A Study Of PF-06647020 For Adult Patients With Advanced S... | NCT02222922 | Trialant
NCT02222922
Sponsor
Pfizer
Status
Completed
Last Update Posted
Dec 17, 2020Actual
Enrollment
138Actual
Phase
Phase 1
Conditions
Neoplasms
Interventions
PF-06647020 Q3W
fluconazole
PF-06647020 Q2W
PF-06647020 combined with Avelumab
Countries
United States
Spain
Protocol Section
Identification Module
NCT ID
NCT02222922
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B7661001
Secondary IDs
ID
Type
Description
Link
2014-003296-36
EudraCT Number
Brief Title
A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors
Official Title
A FIRST-IN-HUMAN PHASE 1, DOSE ESCALATION, SAFETY AND PHARMACOKINETIC STUDY OF PF-06647020 IN ADULT PATIENTS WITH ADVANCED SOLID TUMORS
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Dec 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 17, 2014Actual
Primary Completion Date
Nov 5, 2019Actual
Completion Date
Nov 5, 2019Actual
First Submitted Date
Aug 20, 2014
First Submission Date that Met QC Criteria
Aug 21, 2014
First Posted Date
Aug 22, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 29, 2020
Results First Submitted that Met QC Criteria
Dec 14, 2020
Results First Posted Date
Dec 17, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 14, 2020
Last Update Posted Date
Dec 17, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
To assess the safety and tolerability at increasing dose levels of PF-06647020 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms
Keywords
ADC
PF-06647020
solid tumors
tumors
neoplasm metastasis
TNBC
triple negative breast cancer
NSCLC
non small cell lung cancer
advanced metastatic breast cancer
ovarian cancer
OVCA
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
138Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
PF-06647020 Q3W
Experimental
Investigational drug infused over 60 minutes once every 21 days.
Drug: PF-06647020 Q3W
Drug-drug interaction (DDI)
Experimental
PF-06647020 combined with fluconazole
Drug: fluconazole
PF-06647020 Q2W
Experimental
Investigational drug infused over 60 minutes once every 14 days (28 day cycle)
Drug: PF-06647020 Q2W
PF-06647020 combined with Avelumab
Experimental
PF-06647020 combined with Avelumab administered by infusion
Drug: PF-06647020 combined with Avelumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-06647020 Q3W
Drug
Part 1: PF-06647020 will be administered intravenously every 21 days in cohorts of 2-4 patients starting at a dose of 0.20mg/kg. Increases in dose will continue until MTD is determined.
Part 2: Patients with triple negative breast cancer (pre-selected for PTK7 moderately high to high expression), non small cell lung cancer (pre-selected with moderate to high PTK7 expression) and ovarian cancer patients (unselected for PTK7 expression) will be treated at the MTD or Recommended Phase 2 Dose selected in Part 1.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen
A DLT was any of the following adverse events(AEs) in the first cycle of treatment (within 21 days of first dose or until participant received second infusion if there were treatment delays). (1)Hematologic: including Grade 4 neutropenia lasting >7 days; Febrile neutropenia; Grade >=3 neutropenic infection; Grade 4 anemia; Grade >=3 thrombocytopenia with clinically significant bleeding. (2) Hepatic, including Grade >=3 serum bilirubin, hepatic transaminase or alkaline phosphatase; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=3.0 x upper limit of normal (ULN) concurrent with elevation in bilirubin >=2.0 x ULN; (3) Grade >=3 non-hematologic, non-hepatic major organ toxicities; delayed by >2 weeks in receiving the next scheduled cycle due to persisting toxicities attributable to PF-06647020. A participant was on study for at least 21 days to be evaluable for DLT observation, and could be replaced if they terminated study participation earlier than 21 days.
First Cycle, Day 1 up to Day 21
Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)
Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)
A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
Secondary Outcomes
Measure
Description
Time Frame
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimen
Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06647020 was determined using linear/log trapezoidal method.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Q2W Inclusion Criteria:
Diagnosis of platinum resistant or refractory OVCA having received 2 or fewer prior lines, or recurrent advanced NSCLC having received 3 or fewer prior lines
Performance Status of 0, 1, or 2
Adequate bone marrow, kidney, and liver function
Q2W Exclusion Criteria:
OVCA pts excluded with any of the following: non-epithelial, including malignant mixed mullerian tumors, unresolved bowel obstruction
Brain metastases requiring steroids
Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start
Active and clinically significant bacterial, fungal, or viral infection
Q3W Inclusion Criteria:
Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available
Performance Status of 0 or 1
Adequate bone marrow, kidney, and liver function
Part 2 includes ovarian cancer, target expressing triple negative breast cancer and non small cell lung cancer patients
Q3W Exclusion Criteria:
OVCA pts excluded with any of the following: non-epithelial, including malignant mixed mullerian tumors, prior radiotherapy to pelvis/abdomen, pts with CA-125 only disease, unresolved bowel obstruction
Brain metastases requiring steroids
Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start
Active and clinically significant bacterial, fungal, or viral infection
Johnson M, El-Khoueiry A, Hafez N, Lakhani N, Mamdani H, Rodon J, Sanborn RE, Garcia-Corbacho J, Boni V, Stroh M, Hannah AL, Wang S, Castro H, Spira A. Phase I, First-in-Human Study of the Probody Therapeutic CX-2029 in Adults with Advanced Solid Tumor Malignancies. Clin Cancer Res. 2021 Aug 15;27(16):4521-4530. doi: 10.1158/1078-0432.CCR-21-0194. Epub 2021 Jun 3.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Once every 3 weeks (Q3W) Regimen: A total of 113 participants were enrolled to study treatments and 1 participant in the PF-06647020 2.1 mg/kg treatment group didn't receive any study treatment.
Once every 2 weeks (Q2W) Regimen: A total of 25 participants were enrolled to study treatments and all were treated with study drug.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
PF-06647020 0.2 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Nov 9, 2017
Oct 29, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Not provided
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
PF-06647020 Q3W
fluconazole
Drug
combination drug used for drug-drug interaction sub-study
Drug-drug interaction (DDI)
PF-06647020 Q2W
Drug
Part 1: PF-06647020 will be administered intravenously every 14 days in cohorts of 2-4 patients starting at a dose of 2.1 mg/kg. Increases in dose will continue until MTD is determined.
Part 2: Patients with non-small cell lung cancer (pre-selected for PTK7 moderate to high expression and ovarian cancer patients (unselected for PTK7 expression) will be treated at the MTD or Recommended Phase 2 Dose selected in Part 1.
PF-06647020 Q2W
PF-06647020 combined with Avelumab
Drug
Part 2: Patients with ovarian cancer (unselected for PTK7 expression) will be treated with PF-0664702 plus Avelumab.
PF-06647020 combined with Avelumab
From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. All AEs were graded by the investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.
From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)
Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen
Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameters: absolute neutrophils, lymphopenia, white blood cell, anemia, platelets.
From baseline to end of treatment (approximately 32 months).
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen
Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameters: hypokalemia, hypophosphatemia, aspartate aminotransferase, hyperglycemia, alkaline phosphatase, hyponatremia, alanine aminotransferase, hypoalbuminemia, total bilirubin, hypercalcemia, hypomagnesemia , creatinine, gamma glutamyl transferase, hypocalcemia.
From baseline to end of treatment (approximately 32 months).
Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen
Participants who experienced urinalysis laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with urinalysis laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above.
From baseline to end of treatment (approximately 32 months).
Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen
Participants who experienced coagulation laboratory test abnormalities were summarized according to worst toxicity grade observed for each coagulation laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with coagulation laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameter: partial thromboplastin time.
From baseline to end of treatment (approximately 32 months).
Number of Participants With DLTs - Q2W Regimen
A DLT was any of the following AEs in the first cycle of treatment (within 28 days of first dose or until participant received second infusion if there were treatment delayed) in the single agent dose escalation. (1)Hematologic: including Grade 4 neutropenia lasting >7 days; Febrile neutropenia; Grade >=3 neutropenic infection; Grade 4 thrombocytopenia; treatment delay >14 days because of hematologic AE; (2) Hepatic: including Grade>=3 serum bilirubin, hepatic transaminase or alkaline phosphatase; ALT or AST>=3.0 x ULN concurrent with elevation in bilirubin>=2.0 x ULN; (3) Grade >=3 non-hematologic, non-hepatic major organ toxicities; delayed by >2 weeks in receiving the next scheduled cycle due to persisting toxicities attributable to PF-06647020. Grade >=3 headache lasting >48 hours in presence of supportive care. A participant was on study for at least 28 days to be evaluable for DLT observation, and could be replaced if they terminated study participation earlier than 28 days.
First cycle, Day 1 up to Day 28
Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months)
Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related)
A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months)
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. All AEs were graded by the investigator according to the NCI CTCAE version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.
From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months)
Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen
Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameters: absolute neutrophils, lymphopenia, white blood cell, anemia.
From baseline to end of treatment (approximately 19 months).
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen
Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameters: hypokalemia, hyponatremia, hypomagnesemia, hypoalbuminemia, hypocalcemia, hypophosphatemia, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase.
From baseline to end of treatment (approximately 19 months).
Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q2W Regimen
Participants who experienced urinalysis laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with urinalysis laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above.
Baseline and Day 1 of Cycle 1
Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q2W Regimen
Participants who experienced coagulation laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with coagulation laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameter: prothrombin time international normalized ratio.
From baseline to end of treatment (approximately 19 months).
Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimen
Cmax is maximum observed serum concentration. Cmax for PF-06647020 was observed directly from data.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Clearance (CL) for PF-06647020 - Q3W Regimen
Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance for PF-06647020 was calculated as dose/AUCinf for single dose and dose/AUCtau for multiple dose, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time and AUCtau was the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing).
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimen
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimen
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Observed Accumulation Ratio (Rac) for PF-06647020 - Q3W Regimen
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle).
Time for Cmax (Tmax) for PF-06647020 - Q3W Regimen
Tmax is the time for Cmax. Tmax for PF-06647020 was observed directly from data as time of first occurrence.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimen
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06647020 was determined using linear/log trapezoidal method.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimen
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for PF-06647020 was calculated as AUClast + (Clast*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
AUCtau for PF-06380101 - Q3W Regimen
Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06380101 was determined using linear/log trapezoidal method.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Cmax for PF-06380101 - Q3W Regimen
Cmax is maximum observed serum concentration. Cmax for PF-06380101 was observed directly from data.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
t1/2 for PF-06380101 - Q3W Regimen
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Rac for PF-06380101 - Q3W Regimen
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle).
Tmax for PF-06380101 - Q3W Regimen
Tmax is the time for Cmax. Tmax for PF-06380101 was observed directly from data as time of first occurrence.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
AUClast for PF-06380101 - Q3W Regimen
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06380101 was determined using linear/log trapezoidal method.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
AUCinf for PF-06380101 - Q3W Regimen
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for PF-06380101 was calculated as AUClast + (Clast*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
AUCtau for hu6M024 mAb - Q3W Regimen
Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for hu6M024 mAb was determined using linear/log trapezoidal method.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Cmax for hu6M024 mAb - Q3W Regimen
Cmax is maximum observed serum concentration. Cmax for hu6M024 mAb was observed directly from data.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
t1/2 for hu6M024 mAb - Q3W Regimen
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Rac for hu6M024 mAb - Q3W Regimen
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle).
Tmax for hu6M024 mAb - Q3W Regimen
Tmax is the time for Cmax. Tmax for hu6M024 mAb was observed directly from data as time of first occurrence.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
AUClast for hu6M024 mAb - Q3W Regimen
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for hu6M024 mAb was determined using linear/log trapezoidal method.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
AUCinf for hu6M024 mAb - Q3W Regimen
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for hu6M024 mAb was calculated as AUClast + (Clast*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen
To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06647020.
Prior to the start of treatment on Day 1 of Cycle 1 up to end of treatment (approximately 31 months).
Percentage of Participants With Objective Response - Q3W Regimen
Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).
Duration of Response - Q3W Regimen
Duration of response (DoR) was the time from first documentation of PR or CR to date of first documentation of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).
Disease Control Rate - Q3W Regimen
The disease control rate (DCR) was defined as the percentage of participants with a confirmed CR, PR, non-CR/non-PD or stable disease (SD) according to the appropriate analysis set. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).
Time to Progression - Q3W Regimen
Time to progression (TTP) was the time from start date to the date of the first documentation of PD. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).
Progression Free Survival - Q3W Regimen
Progression free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).
Dose Normalized AUCinf [AUCinf(dn)] for PF-06647020 [DDI Sub-Study]
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
Dose Normalized AUClast [AUClast(dn)] for PF-06647020 [DDI Sub-Study]
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
Dose Normalized AUCtau [AUCtau(dn)] for PF-06647020 [DDI Sub-Study]
AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
Dose Normalized Cmax [Cmax(dn)] for PF-06647020 [DDI Sub-Study]
Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
AUCinf(dn) for PF-06380101 [DDI Sub-Study]
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
AUClast(dn) for PF-06380101 [DDI Sub-Study]
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
AUCtau(dn) for PF-06380101 [DDI Sub-Study]
AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
Cmax(dn) for PF-06380101 [DDI Sub-Study]
Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
AUCinf(dn) for hu6M024 mAb [DDI Sub-Study]
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
AUClast(dn) for hu6M024 mAb [DDI Sub-Study]
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
AUCtau(dn) for hu6M024 mAb [DDI Sub-Study]
AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
Cmax(dn) for hu6M024 mAb [DDI Sub-Study]
Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
AUCtau for PF-06647020 - Q2W Regimen
Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06647020 was determined using linear/log trapezoidal method.
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Cmax for PF-06647020 -Q2W Regimen
Cmax is maximum observed serum concentration. Cmax for PF-06647020 was observed directly from data.
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Vss for PF-06647020 - Q2W Regimen
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
CL for PF-06647020 - Q2W Regimen
Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance for PF-06647020 was calculated as dose/AUCinf for single dose and dose/AUCtau for multiple dose, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time and AUCtau was the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing).
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
t1/2 for PF-06647020 - Q2W Regimen
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Rac for PF-06647020 - Q2W Regimen
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle).
Tmax for PF-06647020 - Q2W Regimen
Tmax is the time for Cmax. Tmax for PF-06647020 was observed directly from data as time of first occurrence.
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
AUClast for PF-06647020 - Q2W Regimen
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06647020 was determined using linear/log trapezoidal method.
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
AUCinf for PF-06647020 - Q2W Regimen
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
AUCtau for PF-06380101 - Q2W Regimen
Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06380101 was determined using linear/log trapezoidal method.
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Cmax for PF-06380101 - Q2W Regimen
Cmax is maximum observed serum concentration. Cmax for PF-06380101 was observed directly from data.
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
t1/2 for PF-06380101 - Q2W Regimen
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Rac for PF-06380101 - Q2W Regimen
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle).
Tmax for PF-06380101 - Q2W Regimen
Tmax is the time for Cmax. Tmax for PF-06380101 was observed directly from data as time of first occurrence.
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
AUClast for PF-06380101- Q2W Regimen
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06380101 was determined using linear/log trapezoidal method.
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
AUCinf for PF-06380101- Q2W Regimen
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
AUCtau for hu6M024 mAb- Q2W Regimen
Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for hu6M024 mA was determined using linear/log trapezoidal method.
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Cmax for hu6M024 mAb -Q2W Regimen
Cmax is maximum observed serum concentration. Cmax for hu6M024 mAb was observed directly from data.
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
t1/2 for hu6M024 mAb - Q2W Regimen
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Rac for hu6M024 mAb - Q2W Regimen
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle).
Tmax for hu6M024 mAb - Q2W Regimen
Tmax is the time for Cmax. Tmax for hu6M024 mAb was observed directly from data as time of first occurrence.
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
AUClast for hu6M024 mAb - Q2W Regimen
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for hu6M024 mAb was determined using linear/log trapezoidal method.
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
AUCinf for hu6M024 mAb - Q2W Regimen
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Number of Participants With ADA and NAb of PF-06647020 - Q2W Regimen
To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06647020.
2 hours before the first dose up to 30 days after the last dose (approximately 18 months).
Percentage of Participants With Objective Response - Q2W Regimen
Percentage of participants with objective response based on assessment of CR or PR according to RECIST version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).
Duration of Response - Q2W Regimen
For participants with an objective response, duration of response (DoR) was the time from first documentation of PR or CR to date of first documentation of PD or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).
Disease Control Rate - Q2W Regimen
The disease control rate (DCR) was defined as the percentage of participants with a confirmed CR, PR or SD according to the appropriate analysis set. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).
Time to Progression - Q2W Regimen
Time to progression (TTP) was the time from start date to the date of the first documentation of PD. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).
Progression Free Survival - Q2W Regimen
Progression free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).
Birmingham
Alabama
35249
United States
Scottsdale Healthcare Hospitals DBA HonorHealth
Scottsdale
Arizona
85258
United States
University of California Davis Comprehensive Cancer Center
Sacramento
California
95817
United States
University of California Davis Medical Center
Sacramento
California
95817
United States
Stanford Cancer Center
Stanford
California
94305
United States
Stanford Hospital and Clinics
Stanford
California
94305
United States
University of Chicago Medicine
Chicago
Illinois
60637
United States
START Midwest
Grand Rapids
Michigan
49503
United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio
Texas
78229
United States
Inova Fairfax Hospital Woodburn GYN Infusion Center
Annandale
Virginia
22003
United States
Mid Atlantic Gynecologic Oncology and Pelvic Surgery Associates (MAGOPSA)
Annandale
Virginia
22003
United States
Fairfax Radiological Consultants
Fairfax
Virginia
22031
United States
Inova Schar Cancer Institute
Fairfax
Virginia
22031
United States
Inova Loudon Hospital
Leesburg
Virginia
20176
United States
Hospital Universitario Fundacion Jimenez Diaz
Madrid
28040
Spain
Hospital Universitario Madrid Sanchinarro
Madrid
28050
Spain
Derived
Maitland ML, Sachdev JC, Sharma MR, Moreno V, Boni V, Kummar S, Stringer-Reasor E, Lakhani N, Moreau AR, Xuan D, Li R, Powell EL, Jackson-Fisher A, Bowers M, Alekar S, Xin X, Tolcher AW, Calvo E. First-in-Human Study of PF-06647020 (Cofetuzumab Pelidotin), an Antibody-Drug Conjugate Targeting Protein Tyrosine Kinase 7, in Advanced Solid Tumors. Clin Cancer Res. 2021 Aug 15;27(16):4511-4520. doi: 10.1158/1078-0432.CCR-20-3757. Epub 2021 Jun 3.
FG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
FG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
FG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
FG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
FG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
FG006
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
FG007
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
FG008
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0035 subjects
FG00496 subjects
FG0056 subjects
FG0063 subjects
FG00710 subjects
FG00812 subjects
Received Treatment
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0034 subjects
FG00496 subjects
FG0056 subjects
FG0063 subjects
FG00710 subjects
FG00812 subjects
COMPLETED
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0032 subjects
FG00458 subjects
FG0053 subjects
FG0061 subjects
FG0076 subjects
FG0086 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0033 subjects
FG00438 subjects
FG0053 subjects
FG0062 subjects
FG0074 subjects
FG0086 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00413 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Participant refused further follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Baseline analysis population included all enrolled participants who received at least 1 full or partial dose of study medication.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
PF-06647020 0.2 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
BG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
BG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
BG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
BG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
BG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
BG006
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
BG007
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
BG008
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0002
BG0012
BG0022
BG0034
BG00496
BG0056
BG0063
BG00710
BG00812
BG009137
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
Mean
Standard Deviation
Years
Title
Denominators
Categories
Q3W Regimen
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG0022
ParticipantsBG003
Age, Customized
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
Count of Participants
Participants
Title
Denominators
Categories
< 18 (Q3W Regimen)
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
Sex: Female, Male
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
Count of Participants
Participants
Title
Denominators
Categories
Q3W Regimen
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
Race (NIH/OMB)
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
Count of Participants
Participants
Title
Denominators
Categories
Q3W Regimen
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
Weight Continuous
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
Mean
Standard Deviation
kilogram (kg)
Title
Denominators
Categories
Q3W Regimen
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
Body Mass Index (BMI) Continuous
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
Q3W Regimen
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen
A DLT was any of the following adverse events(AEs) in the first cycle of treatment (within 21 days of first dose or until participant received second infusion if there were treatment delays). (1)Hematologic: including Grade 4 neutropenia lasting >7 days; Febrile neutropenia; Grade >=3 neutropenic infection; Grade 4 anemia; Grade >=3 thrombocytopenia with clinically significant bleeding. (2) Hepatic, including Grade >=3 serum bilirubin, hepatic transaminase or alkaline phosphatase; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=3.0 x upper limit of normal (ULN) concurrent with elevation in bilirubin >=2.0 x ULN; (3) Grade >=3 non-hematologic, non-hepatic major organ toxicities; delayed by >2 weeks in receiving the next scheduled cycle due to persisting toxicities attributable to PF-06647020. A participant was on study for at least 21 days to be evaluable for DLT observation, and could be replaced if they terminated study participation earlier than 21 days.
Participants enrolled in the dose escalation phase in Q3W regimen who received at least 1 dose of study medication and who did not have major treatment deviations during first cycle with a baseline disease assessment and at least 1 post-baseline disease assessment.
Posted
Count of Participants
Participants
First Cycle, Day 1 up to Day 21
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication.
Posted
Count of Participants
Participants
From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
Primary
Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)
A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication.
Posted
Count of Participants
Participants
From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
Primary
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. All AEs were graded by the investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.
All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication.
Posted
Count of Participants
Participants
From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
Primary
Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen
Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameters: absolute neutrophils, lymphopenia, white blood cell, anemia, platelets.
All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given hematology laboratory test.
Posted
Count of Participants
Participants
From baseline to end of treatment (approximately 32 months).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
Primary
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen
Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameters: hypokalemia, hypophosphatemia, aspartate aminotransferase, hyperglycemia, alkaline phosphatase, hyponatremia, alanine aminotransferase, hypoalbuminemia, total bilirubin, hypercalcemia, hypomagnesemia , creatinine, gamma glutamyl transferase, hypocalcemia.
All participants enrolled in Q3W who received at least 1 full or partial dose of study medication and had at least 1 observation of the given chemistry laboratory test.
Posted
Count of Participants
Participants
From baseline to end of treatment (approximately 32 months).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Primary
Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen
Participants who experienced urinalysis laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with urinalysis laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above.
All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given urinalysis laboratory test.
Posted
Count of Participants
Participants
From baseline to end of treatment (approximately 32 months).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
Primary
Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen
Participants who experienced coagulation laboratory test abnormalities were summarized according to worst toxicity grade observed for each coagulation laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with coagulation laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameter: partial thromboplastin time.
All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given coagulation laboratory test.
Posted
Count of Participants
Participants
From baseline to end of treatment (approximately 32 months).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
Primary
Number of Participants With DLTs - Q2W Regimen
A DLT was any of the following AEs in the first cycle of treatment (within 28 days of first dose or until participant received second infusion if there were treatment delayed) in the single agent dose escalation. (1)Hematologic: including Grade 4 neutropenia lasting >7 days; Febrile neutropenia; Grade >=3 neutropenic infection; Grade 4 thrombocytopenia; treatment delay >14 days because of hematologic AE; (2) Hepatic: including Grade>=3 serum bilirubin, hepatic transaminase or alkaline phosphatase; ALT or AST>=3.0 x ULN concurrent with elevation in bilirubin>=2.0 x ULN; (3) Grade >=3 non-hematologic, non-hepatic major organ toxicities; delayed by >2 weeks in receiving the next scheduled cycle due to persisting toxicities attributable to PF-06647020. Grade >=3 headache lasting >48 hours in presence of supportive care. A participant was on study for at least 28 days to be evaluable for DLT observation, and could be replaced if they terminated study participation earlier than 28 days.
All participants enrolled in Q2W regimen who received at least 1 dose of study medication and who did not have major treatment deviations during first cycle with a baseline disease assessment and at least 1 post baseline disease assessment.
Posted
Count of Participants
Participants
First cycle, Day 1 up to Day 28
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
Primary
Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication.
Posted
Count of Participants
Participants
From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months)
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Primary
Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related)
A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication.
Posted
Count of Participants
Participants
From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months)
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Primary
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. All AEs were graded by the investigator according to the NCI CTCAE version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.
All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication.
Posted
Count of Participants
Participants
From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months)
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
Primary
Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen
Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameters: absolute neutrophils, lymphopenia, white blood cell, anemia.
All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given hematology laboratory test.
Posted
Count of Participants
Participants
From baseline to end of treatment (approximately 19 months).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Primary
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen
Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameters: hypokalemia, hyponatremia, hypomagnesemia, hypoalbuminemia, hypocalcemia, hypophosphatemia, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase.
All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given chemistry laboratory test.
Posted
Count of Participants
Participants
From baseline to end of treatment (approximately 19 months).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Primary
Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q2W Regimen
Participants who experienced urinalysis laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with urinalysis laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above.
All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given urinalysis laboratory test.
Posted
Count of Participants
Participants
Baseline and Day 1 of Cycle 1
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Primary
Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q2W Regimen
Participants who experienced coagulation laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with coagulation laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameter: prothrombin time international normalized ratio.
All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given coagulation laboratory test.
Posted
Count of Participants
Participants
From baseline to end of treatment (approximately 19 months).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Secondary
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimen
Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06647020 was determined using linear/log trapezoidal method.
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram•hour/milliliter (µg•hr/mL)
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
Secondary
Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimen
Cmax is maximum observed serum concentration. Cmax for PF-06647020 was observed directly from data.
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram/milliliter (µg/mL)
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
Secondary
Clearance (CL) for PF-06647020 - Q3W Regimen
Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance for PF-06647020 was calculated as dose/AUCinf for single dose and dose/AUCtau for multiple dose, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time and AUCtau was the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing).
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter/hour (L/hr)
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
Secondary
Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimen
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter (L)
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
Secondary
Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimen
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Mean
Standard Deviation
day
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
OG002
Secondary
Observed Accumulation Ratio (Rac) for PF-06647020 - Q3W Regimen
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
Secondary
Time for Cmax (Tmax) for PF-06647020 - Q3W Regimen
Tmax is the time for Cmax. Tmax for PF-06647020 was observed directly from data as time of first occurrence.
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Median
Full Range
hour
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
OG002
Secondary
Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimen
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06647020 was determined using linear/log trapezoidal method.
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg•hr/mL
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
Secondary
Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimen
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for PF-06647020 was calculated as AUClast + (Clast*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg•hr/mL
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Secondary
AUCtau for PF-06380101 - Q3W Regimen
Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06380101 was determined using linear/log trapezoidal method.
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram•hour/milliliter (ng•hr/mL)
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
Secondary
Cmax for PF-06380101 - Q3W Regimen
Cmax is maximum observed serum concentration. Cmax for PF-06380101 was observed directly from data.
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram/milliliter (ng/mL)
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
Secondary
t1/2 for PF-06380101 - Q3W Regimen
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Mean
Standard Deviation
day
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
OG002
Secondary
Rac for PF-06380101 - Q3W Regimen
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
Secondary
Tmax for PF-06380101 - Q3W Regimen
Tmax is the time for Cmax. Tmax for PF-06380101 was observed directly from data as time of first occurrence.
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Median
Full Range
hour
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
OG002
Secondary
AUClast for PF-06380101 - Q3W Regimen
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06380101 was determined using linear/log trapezoidal method.
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng•hr/mL
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
Secondary
AUCinf for PF-06380101 - Q3W Regimen
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for PF-06380101 was calculated as AUClast + (Clast*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng•hr/mL
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
Secondary
AUCtau for hu6M024 mAb - Q3W Regimen
Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for hu6M024 mAb was determined using linear/log trapezoidal method.
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg•hr/mL
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
Secondary
Cmax for hu6M024 mAb - Q3W Regimen
Cmax is maximum observed serum concentration. Cmax for hu6M024 mAb was observed directly from data.
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
OG002
Secondary
t1/2 for hu6M024 mAb - Q3W Regimen
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Mean
Standard Deviation
day
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
OG002
Secondary
Rac for hu6M024 mAb - Q3W Regimen
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
Secondary
Tmax for hu6M024 mAb - Q3W Regimen
Tmax is the time for Cmax. Tmax for hu6M024 mAb was observed directly from data as time of first occurrence.
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Median
Full Range
hour
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
OG002
Secondary
AUClast for hu6M024 mAb - Q3W Regimen
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for hu6M024 mAb was determined using linear/log trapezoidal method.
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg•hr/mL
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
Secondary
AUCinf for hu6M024 mAb - Q3W Regimen
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for hu6M024 mAb was calculated as AUClast + (Clast*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg•hr/mL
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
Secondary
Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen
To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06647020.
All participants enrolled in Q3W regimen who received at least 1 dose of study treatment and had at least 1 ADA sample collected.
Posted
Count of Participants
Participants
Prior to the start of treatment on Day 1 of Cycle 1 up to end of treatment (approximately 31 months).
ID
Title
Description
OG000
PF-06647020 0.2 mg/kg（Q3W Regimen）
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
OG002
Secondary
Percentage of Participants With Objective Response - Q3W Regimen
Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Participants enrolled in Q3W regimen with measurable disease (non-small cell lung cancer [NSCLC], ovarian cancer [OVCA], triple negative breast cancer [TNBC]) who had received at least 1 dose of study medication and had a baseline tumor assessment.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).
ID
Title
Description
OG000
NSCLC - Q3W Regimen
Participants with NSCLC received PF-06647020 on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
OG001
Secondary
Duration of Response - Q3W Regimen
Duration of response (DoR) was the time from first documentation of PR or CR to date of first documentation of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Participants enrolled in Q3W regimen with measurable disease (NSCLC, OVCA, TNBC) who had received at least 1 dose of study medication and had a baseline tumor assessment. DoR was only for the subset participants with an objective response.
Posted
Median
95% Confidence Interval
month
Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).
ID
Title
Description
OG000
NSCLC - Q3W Regimen
Participants with NSCLC received PF-06647020 on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Secondary
Disease Control Rate - Q3W Regimen
The disease control rate (DCR) was defined as the percentage of participants with a confirmed CR, PR, non-CR/non-PD or stable disease (SD) according to the appropriate analysis set. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Participants enrolled in Q3W regimen with measurable disease (NSCLC, OVCA, TNBC) who had received at least 1 dose of study medication and had a baseline tumor assessment.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).
ID
Title
Description
OG000
NSCLC - Q3W Regimen
Participants with NSCLC received PF-06647020 on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Secondary
Time to Progression - Q3W Regimen
Time to progression (TTP) was the time from start date to the date of the first documentation of PD. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Participants enrolled in Q3W regimen with measurable disease (NSCLC, OVCA, TNBC) who had received at least 1 dose of study medication and had a baseline tumor assessment.
Posted
Median
95% Confidence Interval
month
Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).
ID
Title
Description
OG000
NSCLC - Q3W Regimen
Participants with NSCL received PF-06647020 on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
OG001
OVCA - Q3W Regimen
Participants with OVCA received PF-06647020 on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Secondary
Progression Free Survival - Q3W Regimen
Progression free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Participants enrolled in Q3W regimen with measurable disease (NSCLC, OVCA, TNBC) who had received at least 1 dose of study medication and had a baseline tumor assessment.
Posted
Median
95% Confidence Interval
month
Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).
ID
Title
Description
OG000
NSCLC - Q3W Regimen
Participants with NSCLC received PF-06647020 on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
OG001
OVCA - Q3W Regimen
Participants with OVCA received PF-06647020 on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Secondary
Dose Normalized AUCinf [AUCinf(dn)] for PF-06647020 [DDI Sub-Study]
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose.
The drug-drug interaction (DDI) sub-study was determined to evaluate the effect of multiple dose fluconazole on the PK of PF-06380101 (payload), when fluconazole was co-administered with PF-06647020. The analysis population included participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg•hr/mL/mg
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 2.8 mg/kg (Q3W-DDI)
Participants who participated in the DDI sub-study received a single-dose of PF-06647020 intravenously at 2.8 mg/kg on Cycle 1 Day 1 (Period A).
OG001
PF-06647020 1.4 mg/kg + Fluconazole (Q3W-DDI)
Participants who participated in the DDI sub-study received a single dose of PF-06647020 intravenously at 1.4 mg/kg on Cycle 2 Day 1 (Period B), in combination with fluconazole. Participants started with a loading dose of 400 mg fluconazole by mouth (PO) on the morning of Cycle 1 Day 21 and continued to take fluconazole in the morning at 200 mg PO daily from Cycle 2 Day 1 through Cycle 2 Day 7.
Secondary
Dose Normalized AUClast [AUClast(dn)] for PF-06647020 [DDI Sub-Study]
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose.
Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg•hr/mL/mg
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 2.8 mg/kg (Q3W-DDI)
Participants who participated in the DDI sub-study received a single-dose of PF-06647020 intravenously at 2.8 mg/kg on Cycle 1 Day 1 (Period A).
OG001
PF-06647020 1.4 mg/kg + Fluconazole (Q3W-DDI)
Participants who participated in the DDI sub-study received a single dose of PF-06647020 intravenously at 1.4 mg/kg on Cycle 2 Day 1 (Period B), in combination with fluconazole. Participants started with a loading dose of 400 mg fluconazole by mouth (PO) on the morning of Cycle 1 Day 21 and continued to take fluconazole in the morning at 200 mg PO daily from Cycle 2 Day 1 through Cycle 2 Day 7.
Secondary
Dose Normalized AUCtau [AUCtau(dn)] for PF-06647020 [DDI Sub-Study]
AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose.
Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg•hr/mL/mg
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 2.8 mg/kg (Q3W-DDI)
Participants who participated in the DDI sub-study received a single-dose of PF-06647020 intravenously at 2.8 mg/kg on Cycle 1 Day 1 (Period A).
OG001
PF-06647020 1.4 mg/kg + Fluconazole (Q3W-DDI)
Participants who participated in the DDI sub-study received a single dose of PF-06647020 intravenously at 1.4 mg/kg on Cycle 2 Day 1 (Period B), in combination with fluconazole. Participants started with a loading dose of 400 mg fluconazole by mouth (PO) on the morning of Cycle 1 Day 21 and continued to take fluconazole in the morning at 200 mg PO daily from Cycle 2 Day 1 through Cycle 2 Day 7.
Units
Counts
Secondary
Dose Normalized Cmax [Cmax(dn)] for PF-06647020 [DDI Sub-Study]
Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.
Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL/mg
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 2.8 mg/kg (Q3W-DDI)
Participants who participated in the DDI sub-study received a single-dose of PF-06647020 intravenously at 2.8 mg/kg on Cycle 1 Day 1 (Period A).
OG001
PF-06647020 1.4 mg/kg + Fluconazole (Q3W-DDI)
Participants who participated in the DDI sub-study received a single dose of PF-06647020 intravenously at 1.4 mg/kg on Cycle 2 Day 1 (Period B), in combination with fluconazole. Participants started with a loading dose of 400 mg fluconazole by mouth (PO) on the morning of Cycle 1 Day 21 and continued to take fluconazole in the morning at 200 mg PO daily from Cycle 2 Day 1 through Cycle 2 Day 7.
Units
Counts
Secondary
AUCinf(dn) for PF-06380101 [DDI Sub-Study]
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose.
Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng•hr/mL/mg
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 2.8 mg/kg (Q3W-DDI)
Participants who participated in the DDI sub-study received a single-dose of PF-06647020 intravenously at 2.8 mg/kg on Cycle 1 Day 1 (Period A).
OG001
PF-06647020 1.4 mg/kg + Fluconazole (Q3W-DDI)
Participants who participated in the DDI sub-study received a single dose of PF-06647020 intravenously at 1.4 mg/kg on Cycle 2 Day 1 (Period B), in combination with fluconazole. Participants started with a loading dose of 400 mg fluconazole by mouth (PO) on the morning of Cycle 1 Day 21 and continued to take fluconazole in the morning at 200 mg PO daily from Cycle 2 Day 1 through Cycle 2 Day 7.
Units
Counts
Secondary
AUClast(dn) for PF-06380101 [DDI Sub-Study]
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose.
Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng•hr/mL/mg
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 2.8 mg/kg (Q3W-DDI)
Participants who participated in the DDI sub-study received a single-dose of PF-06647020 intravenously at 2.8 mg/kg on Cycle 1 Day 1 (Period A).
OG001
PF-06647020 1.4 mg/kg + Fluconazole (Q3W-DDI)
Participants who participated in the DDI sub-study received a single dose of PF-06647020 intravenously at 1.4 mg/kg on Cycle 2 Day 1 (Period B), in combination with fluconazole. Participants started with a loading dose of 400 mg fluconazole by mouth (PO) on the morning of Cycle 1 Day 21 and continued to take fluconazole in the morning at 200 mg PO daily from Cycle 2 Day 1 through Cycle 2 Day 7.
Units
Secondary
AUCtau(dn) for PF-06380101 [DDI Sub-Study]
AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose.
Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng•hr/mL/mg
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 2.8 mg/kg (Q3W-DDI)
Participants who participated in the DDI sub-study received a single-dose of PF-06647020 intravenously at 2.8 mg/kg on Cycle 1 Day 1 (Period A).
OG001
PF-06647020 1.4 mg/kg + Fluconazole (Q3W-DDI)
Participants who participated in the DDI sub-study received a single dose of PF-06647020 intravenously at 1.4 mg/kg on Cycle 2 Day 1 (Period B), in combination with fluconazole. Participants started with a loading dose of 400 mg fluconazole by mouth (PO) on the morning of Cycle 1 Day 21 and continued to take fluconazole in the morning at 200 mg PO daily from Cycle 2 Day 1 through Cycle 2 Day 7.
Units
Counts
Secondary
Cmax(dn) for PF-06380101 [DDI Sub-Study]
Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.
Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL/mg
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 2.8 mg/kg (Q3W-DDI)
Participants who participated in the DDI sub-study received a single-dose of PF-06647020 intravenously at 2.8 mg/kg on Cycle 1 Day 1 (Period A).
OG001
PF-06647020 1.4 mg/kg + Fluconazole (Q3W-DDI)
Participants who participated in the DDI sub-study received a single dose of PF-06647020 intravenously at 1.4 mg/kg on Cycle 2 Day 1 (Period B), in combination with fluconazole. Participants started with a loading dose of 400 mg fluconazole by mouth (PO) on the morning of Cycle 1 Day 21 and continued to take fluconazole in the morning at 200 mg PO daily from Cycle 2 Day 1 through Cycle 2 Day 7.
Units
Counts
Participants
Secondary
AUCinf(dn) for hu6M024 mAb [DDI Sub-Study]
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose.
Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg•hr/mL/mg
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 2.8 mg/kg (Q3W-DDI)
Participants who participated in the DDI sub-study received a single-dose of PF-06647020 intravenously at 2.8 mg/kg on Cycle 1 Day 1 (Period A).
OG001
PF-06647020 1.4 mg/kg + Fluconazole (Q3W-DDI)
Participants who participated in the DDI sub-study received a single dose of PF-06647020 intravenously at 1.4 mg/kg on Cycle 2 Day 1 (Period B), in combination with fluconazole. Participants started with a loading dose of 400 mg fluconazole by mouth (PO) on the morning of Cycle 1 Day 21 and continued to take fluconazole in the morning at 200 mg PO daily from Cycle 2 Day 1 through Cycle 2 Day 7.
Units
Counts
Secondary
AUClast(dn) for hu6M024 mAb [DDI Sub-Study]
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose.
Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg•hr/mL/mg
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 2.8 mg/kg (Q3W-DDI)
Participants who participated in the DDI sub-study received a single-dose of PF-06647020 intravenously at 2.8 mg/kg on Cycle 1 Day 1 (Period A).
OG001
PF-06647020 1.4 mg/kg + Fluconazole (Q3W-DDI)
Participants who participated in the DDI sub-study received a single dose of PF-06647020 intravenously at 1.4 mg/kg on Cycle 2 Day 1 (Period B), in combination with fluconazole. Participants started with a loading dose of 400 mg fluconazole by mouth (PO) on the morning of Cycle 1 Day 21 and continued to take fluconazole in the morning at 200 mg PO daily from Cycle 2 Day 1 through Cycle 2 Day 7.
Units
Secondary
AUCtau(dn) for hu6M024 mAb [DDI Sub-Study]
AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose.
Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg•hr/mL/mg
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 2.8 mg/kg (Q3W-DDI)
Participants who participated in the DDI sub-study received a single-dose of PF-06647020 intravenously at 2.8 mg/kg on Cycle 1 Day 1 (Period A).
OG001
PF-06647020 1.4 mg/kg + Fluconazole (Q3W-DDI)
Participants who participated in the DDI sub-study received a single dose of PF-06647020 intravenously at 1.4 mg/kg on Cycle 2 Day 1 (Period B), in combination with fluconazole. Participants started with a loading dose of 400 mg fluconazole by mouth (PO) on the morning of Cycle 1 Day 21 and continued to take fluconazole in the morning at 200 mg PO daily from Cycle 2 Day 1 through Cycle 2 Day 7.
Units
Counts
Secondary
Cmax(dn) for hu6M024 mAb [DDI Sub-Study]
Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.
Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL/mg
pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
ID
Title
Description
OG000
PF-06647020 2.8 mg/kg (Q3W-DDI)
Participants who participated in the DDI sub-study received a single-dose of PF-06647020 intravenously at 2.8 mg/kg on Cycle 1 Day 1 (Period A).
OG001
PF-06647020 1.4 mg/kg + Fluconazole (Q3W-DDI)
Participants who participated in the DDI sub-study received a single dose of PF-06647020 intravenously at 1.4 mg/kg on Cycle 2 Day 1 (Period B), in combination with fluconazole. Participants started with a loading dose of 400 mg fluconazole by mouth (PO) on the morning of Cycle 1 Day 21 and continued to take fluconazole in the morning at 200 mg PO daily from Cycle 2 Day 1 through Cycle 2 Day 7.
Units
Counts
Participants
Secondary
AUCtau for PF-06647020 - Q2W Regimen
Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06647020 was determined using linear/log trapezoidal method.
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg•hr/mL
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Secondary
Cmax for PF-06647020 -Q2W Regimen
Cmax is maximum observed serum concentration. Cmax for PF-06647020 was observed directly from data.
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Secondary
Vss for PF-06647020 - Q2W Regimen
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Secondary
CL for PF-06647020 - Q2W Regimen
Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance for PF-06647020 was calculated as dose/AUCinf for single dose and dose/AUCtau for multiple dose, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time and AUCtau was the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing).
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/hr
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Secondary
t1/2 for PF-06647020 - Q2W Regimen
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Mean
Standard Deviation
day
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
OG002
Secondary
Rac for PF-06647020 - Q2W Regimen
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Secondary
Tmax for PF-06647020 - Q2W Regimen
Tmax is the time for Cmax. Tmax for PF-06647020 was observed directly from data as time of first occurrence.
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Median
Full Range
hour
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
OG002
Secondary
AUClast for PF-06647020 - Q2W Regimen
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06647020 was determined using linear/log trapezoidal method.
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg•hr/mL
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Secondary
AUCinf for PF-06647020 - Q2W Regimen
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg•hr/mL
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Secondary
AUCtau for PF-06380101 - Q2W Regimen
Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06380101 was determined using linear/log trapezoidal method.
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng•hr/mL
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Secondary
Cmax for PF-06380101 - Q2W Regimen
Cmax is maximum observed serum concentration. Cmax for PF-06380101 was observed directly from data.
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Secondary
t1/2 for PF-06380101 - Q2W Regimen
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Mean
Standard Deviation
day
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
OG002
Secondary
Rac for PF-06380101 - Q2W Regimen
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Secondary
Tmax for PF-06380101 - Q2W Regimen
Tmax is the time for Cmax. Tmax for PF-06380101 was observed directly from data as time of first occurrence.
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Median
Full Range
hour
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
OG002
Secondary
AUClast for PF-06380101- Q2W Regimen
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06380101 was determined using linear/log trapezoidal method.
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng•hr/mL
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Secondary
AUCinf for PF-06380101- Q2W Regimen
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng•hr/mL
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Secondary
AUCtau for hu6M024 mAb- Q2W Regimen
Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for hu6M024 mA was determined using linear/log trapezoidal method.
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg•hr/mL
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Secondary
Cmax for hu6M024 mAb -Q2W Regimen
Cmax is maximum observed serum concentration. Cmax for hu6M024 mAb was observed directly from data.
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Secondary
t1/2 for hu6M024 mAb - Q2W Regimen
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Mean
Standard Deviation
day
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
OG002
Secondary
Rac for hu6M024 mAb - Q2W Regimen
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
Ratio
pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Secondary
Tmax for hu6M024 mAb - Q2W Regimen
Tmax is the time for Cmax. Tmax for hu6M024 mAb was observed directly from data as time of first occurrence.
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Median
Full Range
hour
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
OG002
Secondary
AUClast for hu6M024 mAb - Q2W Regimen
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for hu6M024 mAb was determined using linear/log trapezoidal method.
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg•hr/mL
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Secondary
AUCinf for hu6M024 mAb - Q2W Regimen
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg•hr/mL
pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
Secondary
Number of Participants With ADA and NAb of PF-06647020 - Q2W Regimen
To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06647020.
All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had at least 1 ADA sample collected.
Posted
Count of Participants
Participants
2 hours before the first dose up to 30 days after the last dose (approximately 18 months).
ID
Title
Description
OG000
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Secondary
Percentage of Participants With Objective Response - Q2W Regimen
Percentage of participants with objective response based on assessment of CR or PR according to RECIST version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Participants enrolled in Q2W with measurable disease (NSCLC, OVCA) who had received at least 1 dose of study medication and had a baseline tumor assessment.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).
ID
Title
Description
OG000
NSCLC - Q2W Regimen
Participants with NSCLC received PF-06647020 on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
OG001
OVCA - Q2W Regimen
Participants with OVCA received PF-06647020 on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Secondary
Duration of Response - Q2W Regimen
For participants with an objective response, duration of response (DoR) was the time from first documentation of PR or CR to date of first documentation of PD or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Participants enrolled in Q2W regimen with measurable disease (NSCLC, OVCA) who had received at least 1 dose of study medication and had a baseline tumor assessment. DoR was only for the subset participants with an objective response.
Posted
Median
95% Confidence Interval
month
Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).
ID
Title
Description
OG000
NSCLC - Q2W Regimen
Participants with NSCLC received PF-06647020 on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Secondary
Disease Control Rate - Q2W Regimen
The disease control rate (DCR) was defined as the percentage of participants with a confirmed CR, PR or SD according to the appropriate analysis set. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Participants enrolled in Q2W regimen with measurable disease (NSCLC, OVCA) who had received at least 1 dose of study medication and had a baseline tumor assessment.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).
ID
Title
Description
OG000
NSCLC - Q2W Regimen
Participants with NSCLC received PF-06647020 on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
OG001
Secondary
Time to Progression - Q2W Regimen
Time to progression (TTP) was the time from start date to the date of the first documentation of PD. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Participants enrolled in Q2W regimen with measurable disease (NSCLC, OVCA) who had received at least 1 dose of study medication and had a baseline tumor assessment.
Posted
Median
95% Confidence Interval
month
Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).
ID
Title
Description
OG000
NSCLC - Q2W Regimen
Participants with NSCLC received PF-06647020 on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
OG001
OVCA - Q2W Regimen
Participants with OVCA received PF-06647020 on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Secondary
Progression Free Survival - Q2W Regimen
Progression free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Participants enrolled in Q2W regimen with measurable disease (NSCLC, OVCA) who had received at least 1 dose of study medication and had a baseline tumor assessment.
Posted
Median
95% Confidence Interval
month
Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).
ID
Title
Description
OG000
NSCLC - Q2W Regimen
Participants with NSCLC received PF-06647020 on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
OG001
OVCA - Q2W Regimen
Participants with OVCA received PF-06647020 on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Time Frame
From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
Description
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
PF-06647020 0.2 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
0
2
0
2
2
2
EG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
0
2
0
2
2
2
EG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
0
2
0
2
2
2
EG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
0
4
1
4
4
4
EG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
13
96
33
96
93
96
EG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
0
6
2
6
6
6
EG006
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
0
3
1
3
3
3
EG007
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
0
10
4
10
10
10
EG008
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
2
12
7
12
12
12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG0030 affected4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0071 affected10 at risk
EG0080 affected12 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Large intestinal stenosis
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Fatigue
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pyrexia
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Abdominal wall abscess
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Device related infection
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Meningitis viral
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Septic shock
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Syncope
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Respiratory arrest
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypotension
Vascular disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neutropenic infection
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Otitis media
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG0031 affected4 at risk
EG00417 affected96 at risk
EG0052 affected6 at risk
EG0060 affected3 at risk
EG0072 affected10 at risk
EG0083 affected12 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Cataract
Eye disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dry eye
Eye disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Macular oedema
Eye disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Photophobia
Eye disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Swelling of eyelid
Eye disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vision blurred
Eye disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0011 affected2 at risk
EG0021 affected2 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Chest pain
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Chills
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Fatigue
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0022 affected2 at risk
EG003
Gait disturbance
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Localised oedema
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oedema peripheral
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pain
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pyrexia
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Breast cellulitis
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Infection
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 22.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Weight decreased
Investigations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0011 affected2 at risk
EG0021 affected2 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0012 affected2 at risk
EG0020 affected2 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.1
Non-systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Depression
Psychiatric disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypotension
Vascular disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Superior vena cava syndrome
Vascular disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Eye irritation
Eye disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Eyelid rash
Eye disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Catheter site erythema
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Catheter site pain
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Malaise
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oedema
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Candida infection
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Joint instability
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Malignant ascites
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Peripheral sensorimotor neuropathy
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rash vesicular
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hot flush
Vascular disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D005833
Genital Neoplasms, Female
D014565
Urogenital Neoplasms
D000091662
Genital Diseases
D004700
Endocrine System Diseases
D006058
Gonadal Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D015725
Fluconazole
C000609138
avelumab
Ancestor Terms
ID
Term
D014230
Triazoles
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
9 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
10 subjects
FG0052 subjects
FG0062 subjects
FG0074 subjects
FG0081 subjects
6 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0083 subjects
4
ParticipantsBG00496
ParticipantsBG0056
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG009112
Title
Measurements
BG00073.0± 2.8
BG00157.5± 14.8
BG00261.0± 2.8
BG00355.0± 13.6
BG00458.1± 11.8
BG00559.5± 8.4
BG00958.4± 11.6
Q2W Regimen
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG0063
ParticipantsBG00710
ParticipantsBG00812
ParticipantsBG00925
Title
Measurements
BG00664.0± 2.6
BG00765.5± 8.9
BG00865.6± 8.0
BG009
2
ParticipantsBG0034
ParticipantsBG00496
ParticipantsBG0056
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG009112
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
18-44 (Q3W Regimen)
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG0022
ParticipantsBG0034
ParticipantsBG00496
ParticipantsBG0056
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG009112
Title
Measurements
BG0000
BG0010
BG0020
BG003
45-64 (Q3W Regimen)
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG0022
ParticipantsBG0034
ParticipantsBG00496
ParticipantsBG0056
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG009112
Title
Measurements
BG0000
BG0011
BG0022
BG003
>= 65 (Q3W Regimen)
ParticipantsBG0002
ParticipantsBG0012
ParticipantsBG0022
ParticipantsBG0034
ParticipantsBG00496
ParticipantsBG0056
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG009112
Title
Measurements
BG0002
BG0011
BG0020
BG003
< 18 (Q2W Regimen)
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG0063
ParticipantsBG00710
ParticipantsBG00812
ParticipantsBG00925
Title
Measurements
BG0000
BG0010
BG0020
BG003
18-44 (Q2W Regimen)
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG0063
ParticipantsBG00710
ParticipantsBG00812
ParticipantsBG00925
Title
Measurements
BG0000
BG0010
BG0020
BG003
45-64 (Q2W Regimen)
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG0063
ParticipantsBG00710
ParticipantsBG00812
ParticipantsBG00925
Title
Measurements
BG0000
BG0010
BG0020
BG003
>= 65 (Q2W Regimen)
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG0063
ParticipantsBG00710
ParticipantsBG00812
ParticipantsBG00925
Title
Measurements
BG0000
BG0010
BG0020
BG003
2
ParticipantsBG0034
ParticipantsBG00496
ParticipantsBG0056
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG009112
Title
Measurements
Female
BG0002
BG0011
BG0021
BG0033
BG00480
BG0055
BG0060
BG0070
BG0080
BG00992
Male
BG0000
BG0011
BG0021
BG0031
BG004
Q2W Regimen
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG0063
ParticipantsBG00710
ParticipantsBG00812
ParticipantsBG00925
Title
Measurements
Female
BG0000
BG0010
BG0020
BG003
2
ParticipantsBG0034
ParticipantsBG00496
ParticipantsBG0056
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG009112
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0031
BG004
White
BG0002
BG0012
BG0022
BG0033
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Q2W Regimen
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG0063
ParticipantsBG00710
ParticipantsBG00812
ParticipantsBG00925
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG003
2
ParticipantsBG0034
ParticipantsBG00496
ParticipantsBG0056
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG009112
Title
Measurements
BG00049.2± 10.2
BG00168.8± 21.9
BG00268.7± 5.2
BG00380.7± 27.3
BG00469.9± 16.4
BG00572.2± 14.2
BG00970.0± 16.6
Q2W Regimen
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG0063
ParticipantsBG00710
ParticipantsBG00812
ParticipantsBG00925
Title
Measurements
BG00668.4± 23.8
BG00778.1± 25.5
BG00868.3± 22.5
BG009
2
ParticipantsBG0034
ParticipantsBG00496
ParticipantsBG0056
ParticipantsBG0060
ParticipantsBG0070
ParticipantsBG0080
ParticipantsBG009112
Title
Measurements
BG00018.3± 2.0
BG00122.7± 2.7
BG00223.6± 2.0
BG00327.6± 7.7
BG00425.6± 5.5
BG00526.2± 4.7
BG00925.5± 5.5
Q2W Regimen
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG0063
ParticipantsBG00710
ParticipantsBG00812
ParticipantsBG00925
Title
Measurements
BG00624.9± 7.1
BG00729.9± 9.1
BG00825.6± 8.8
BG009
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
4
OG00415
OG0056
0
OG0040
OG0052
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00496
OG0056
Title
Denominators
Categories
AEs
Title
Measurements
OG0002
OG0012
OG0022
OG0034
OG00496
OG0056
SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00496
OG0056
Title
Denominators
Categories
AEs
Title
Measurements
OG0001
OG0011
OG0021
OG0034
OG00484
OG0055
SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG001
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00496
OG0056
Title
Denominators
Categories
Grade 1 (all-causality)
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0046
OG0050
Grade 2 (all-causality)
Title
Measurements
OG0001
OG0012
OG0020
OG003
Grade 3 (all-causality)
Title
Measurements
OG0001
OG0010
OG0021
OG003
Grade 4 (all-causality)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 5 (all-causality)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Missing or Unknown (all-causality)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 1 (treatment-related)
Title
Measurements
OG0000
OG0011
OG0021
OG003
Grade 2 (treatment-related)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3 (treatment-related)
Title
Measurements
OG0001
OG0010
OG0020
OG003
Grade 4 (treatment-related)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 5 (treatment-related)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Missing or Unknown (treatment-related)
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00496
OG0055
Title
Denominators
Categories
Absolute neutrophils
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG00428
OG0052
Lymphopenia
Title
Measurements
OG0001
OG0011
OG0020
OG003
White blood cells
Title
Measurements
OG0000
OG0010
OG0020
OG003
Anemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Platelets
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00496
OG0055
Title
Denominators
Categories
Hypokalemia
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0048
OG0051
Hypophosphatemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Aspartate aminotransferase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hyperglycemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Alkaline phosphatase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hyponatremia
Title
Measurements
OG0001
OG0010
OG0020
OG003
Alanine aminotransferase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypoalbuminemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Total bilirubin
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypercalcemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypomagnesemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatinine
Title
Measurements
OG0000
OG0010
OG0020
OG003
Gamma glutamyl transferase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hypocalcemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00493
OG0055
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00491
OG0055
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG001
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0022
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
AEs
Title
Measurements
OG0003
OG00110
OG00212
SAEs
Title
Measurements
OG0001
OG0014
OG0027
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
AEs
Title
Measurements
OG0003
OG00110
OG00212
SAEs
Title
Measurements
OG0000
OG0012
OG0022
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Grade 1 (all-causality)
Title
Measurements
OG0000
OG0010
OG0020
Grade 2 (all-causality)
Title
Measurements
OG0002
OG0013
OG0022
Grade 3 (all-causality)
Title
Measurements
OG0001
OG0015
OG0027
Grade 4 (all-causality)
Title
Measurements
OG0000
OG0012
OG0022
Grade 5 (all-causality)
Title
Measurements
OG0000
OG0010
OG0021
Missing or Unknown (all-causality)
Title
Measurements
OG0000
OG0010
OG0020
Grade 1 (treatment-related)
Title
Measurements
OG0000
OG0010
OG0020
Grade 2 (treatment-related)
Title
Measurements
OG0003
OG0014
OG0025
Grade 3 (treatment-related)
Title
Measurements
OG0000
OG0014
OG0026
Grade 4 (treatment-related)
Title
Measurements
OG0000
OG0012
OG0021
Grade 5 (treatment-related)
Title
Measurements
OG0000
OG0010
OG0020
Missing or Unknown (treatment-related)
Title
Measurements
OG0000
OG0010
OG0020
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Absolute neutrophils
Title
Measurements
OG0000
OG0013
OG0025
Lymphopenia
Title
Measurements
OG0000
OG0010
OG0024
White blood cells
Title
Measurements
OG0000
OG0012
OG0022
Anemia
Title
Measurements
OG0000
OG0010
OG0021
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Hypokalemia
Title
Measurements
OG0000
OG0011
OG0022
Hyponatremia
Title
Measurements
OG0000
OG0011
OG0022
Hypomagnesemia
Title
Measurements
OG0000
OG0010
OG0022
Hypoalbuminemia
Title
Measurements
OG0000
OG0011
OG0021
Hypocalcemia
Title
Measurements
OG0001
OG0010
OG0021
Hypophosphatemia
Title
Measurements
OG0000
OG0011
OG0020
Alanine aminotransferase
Title
Measurements
OG0000
OG0010
OG0021
Aspartate aminotransferase
Title
Measurements
OG0000
OG0010
OG0021
Alkaline phosphatase
Title
Measurements
OG0000
OG0010
OG0021
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0000
OG0012
OG0021
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00485
OG0056
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00483
ParticipantsOG0055
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4, Multiple Dose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00485
OG0056
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00485
ParticipantsOG0056
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4, Multiple Dose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00485
OG0056
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00482
ParticipantsOG0055
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4, Multiple Dose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00485
OG0056
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00482
ParticipantsOG0055
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4, Multiple Dose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00485
OG0056
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00482
ParticipantsOG0055
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4, Multiple Dose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0001
OG0010
OG0021
OG0033
OG00441
OG0052
Title
Denominators
Categories
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0031.046± 61
OG0041.094± 39
OG005NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00485
OG0056
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00485
ParticipantsOG0056
Title
Measurements
OG000NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4, Multiple Dose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00485
OG0056
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00485
ParticipantsOG0056
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4, Multiple Dose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00485
OG0056
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00482
ParticipantsOG0055
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4, Multiple Dose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00485
OG0056
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00482
ParticipantsOG0055
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4, Multiple Dose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00485
OG0056
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00485
ParticipantsOG0056
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4, Multiple Dose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00485
OG0056
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00481
ParticipantsOG0054
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4, Multiple Dose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0001
OG0010
OG0021
OG0033
OG00442
OG0052
Title
Denominators
Categories
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0030.5454± 40
OG0040.8916± 41
OG005NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00485
OG0056
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00485
ParticipantsOG0056
Title
Measurements
OG000NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4, Multiple Dose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00485
OG0056
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00485
ParticipantsOG0056
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4, Multiple Dose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00485
OG0056
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00481
ParticipantsOG0054
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4, Multiple Dose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00485
OG0056
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00483
ParticipantsOG0055
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4, Multiple Dose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00485
OG0056
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00485
ParticipantsOG0056
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4, Multiple Dose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00485
OG0056
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00481
ParticipantsOG0055
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4, Multiple Dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0001
OG0010
OG0021
OG0033
OG00441
OG0052
Title
Denominators
Categories
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0031.022± 108
OG0040.9865± 48
OG005NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00485
OG0056
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00485
ParticipantsOG0056
Title
Measurements
OG000NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4, Multiple Dose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00485
OG0056
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00485
ParticipantsOG0056
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4, Multiple Dose
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
OG002
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00485
OG0056
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00481
ParticipantsOG0055
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
Cycle 4, Multiple Dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
OG003
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
OG004
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
OG005
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0034
OG00496
OG0056
Title
Denominators
Categories
Overall incidence of ADA
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
ParticipantsOG00493
ParticipantsOG0055
Title
Measurements
OG0001
OG0010
OG0020
OG003
Overall incidence of NAb
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0034
OVCA - Q3W Regimen
Participants with OVCA received PF-06647020 on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
OG002
TNBC - Q3W Regimen
Participants with TNBC received PF-06647020 on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Units
Counts
Participants
OG00025
OG00144
OG00229
Title
Denominators
Categories
Title
Measurements
OG00016.0(4.5 to 36.1)
OG00127.3(15.0 to 42.8)
OG00220.7(8.0 to 39.7)
OG001
OVCA - Q3W Regimen
Participants with OVCA received PF-06647020 on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
OG002
TNBC - Q3W Regimen
Participants with TNBC received PF-06647020 on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Units
Counts
Participants
OG0004
OG00112
OG0026
Title
Denominators
Categories
Title
Measurements
OG0005.7(1.5 to 9.9)
OG0014.2(2.8 to 8.3)
OG0024.3(1.3 to 10.2)
OG001
OVCA - Q3W Regimen
Participants with OVCA received PF-06647020 on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
OG002
TNBC - Q3W Regimen
Participants with TNBC received PF-06647020 on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Units
Counts
Participants
OG00025
OG00144
OG00229
Title
Denominators
Categories
Title
Measurements
OG00056.0(34.93 to 75.60)
OG00172.7(57.21 to 85.04)
OG00248.3(29.45 to 67.47)
OG002
TNBC - Q3W Regimen
Participants with TNBC received PF-06647020 on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Units
Counts
Participants
OG00025
OG00144
OG00229
Title
Denominators
Categories
Title
Measurements
OG0002.9(1.4 to 6.1)
OG0013.1(2.3 to 5.5)
OG0022.2(1.4 to 5.5)
OG002
TNBC - Q3W Regimen
Participants with TNBC received PF-06647020 on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
The ratio and 90% confidence interval were expressed as percentages.
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0003
ParticipantsOG00110
ParticipantsOG00212
Title
Measurements
OG0003627± 62
OG0016541± 38
OG0026319± 45
Cycle 3, Multiple Dose
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG00210
Title
Measurements
OG000
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0003
ParticipantsOG00110
ParticipantsOG00212
Title
Measurements
OG00097.79± 14
OG00199.69± 32
OG00290.28± 32
Cycle 3, Multiple Dose
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG00210
Title
Measurements
OG000
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0019
ParticipantsOG00212
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0012.566± 44
OG0022.953± 36
Cycle 3, Multiple Dose
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG00210
Title
Measurements
OG000
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0019
ParticipantsOG00212
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0010.03075± 49
OG0020.03238± 39
Cycle 3, Multiple Dose
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG00210
Title
Measurements
OG000
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0019
ParticipantsOG00212
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0012.700± 0.625
OG0022.874± 0.385
Cycle 3, Multiple Dose
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG00210
Title
Measurements
OG000
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0001
OG0017
OG00210
Title
Denominators
Categories
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0011.425± 35
OG0021.211± 18
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0003
ParticipantsOG00110
ParticipantsOG00212
Title
Measurements
OG0003.98(0.983 to 4.02)
OG0012.45(0.983 to 23.7)
OG0021.05(0.900 to 4.00)
Cycle 3, Multiple Dose
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG00210
Title
Measurements
OG000
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0003
ParticipantsOG00110
ParticipantsOG00212
Title
Measurements
OG0003641± 62
OG0016490± 39
OG0026342± 46
Cycle 3, Multiple Dose
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG00210
Title
Measurements
OG000
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG0019
ParticipantsOG00212
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0016798± 41
OG0026535± 46
Cycle 3, Multiple Dose
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG00210
Title
Measurements
OG000
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0003
ParticipantsOG00110
ParticipantsOG00212
Title
Measurements
OG000568.9± 12
OG001860.3± 52
OG002740.5± 62
Cycle 3, Multiple Dose
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG00210
Title
Measurements
OG000
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0003
ParticipantsOG00110
ParticipantsOG00212
Title
Measurements
OG0006.084± 59
OG0016.665± 49
OG0025.779± 59
Cycle 3, Multiple Dose
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG00210
Title
Measurements
OG000
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0003
ParticipantsOG00110
ParticipantsOG00212
Title
Measurements
OG0002.507± 0.411
OG0012.646± 0.453
OG0022.592± 0.331
Cycle 3, Multiple Dose
ParticipantsOG0001
ParticipantsOG0016
ParticipantsOG00210
Title
Measurements
OG000
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0001
OG0017
OG00210
Title
Denominators
Categories
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0010.9980± 26
OG0020.9657± 25
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0003
ParticipantsOG00110
ParticipantsOG00212
Title
Measurements
OG0003.98(3.98 to 4.02)
OG0014.05(3.75 to 72.1)
OG00224.7(3.72 to 48.5)
Cycle 3, Multiple Dose
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG00210
Title
Measurements
OG000
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0003
ParticipantsOG00110
ParticipantsOG00212
Title
Measurements
OG000569.9± 12
OG001866.0± 53
OG002743.5± 63
Cycle 3, Multiple Dose
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG00210
Title
Measurements
OG000
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0003
ParticipantsOG00110
ParticipantsOG00212
Title
Measurements
OG000584.4± 11
OG001888.5± 54
OG002763.2± 62
Cycle 3, Multiple Dose
ParticipantsOG0001
ParticipantsOG0016
ParticipantsOG00210
Title
Measurements
OG000
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0003
ParticipantsOG00110
ParticipantsOG00212
Title
Measurements
OG0004089± 52
OG0017325± 47
OG0026911± 44
Cycle 3, Multiple Dose
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG00210
Title
Measurements
OG000
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0003
ParticipantsOG00110
ParticipantsOG00212
Title
Measurements
OG00072.04± 23
OG001102.1± 38
OG00286.26± 27
Cycle 3, Multiple Dose
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG00210
Title
Measurements
OG000
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00212
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0013.436± 0.750
OG0023.645± 0.752
Cycle 3, Multiple Dose
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0027
Title
Measurements
OG000
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0001
OG0017
OG00210
Title
Denominators
Categories
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0011.280± 32
OG0021.301± 35
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0003
ParticipantsOG00110
ParticipantsOG00212
Title
Measurements
OG0003.98(1.00 to 4.02)
OG0013.87(0.983 to 4.35)
OG0021.05(0.900 to 23.8)
Cycle 3, Multiple Dose
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG00210
Title
Measurements
OG000
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0003
ParticipantsOG00110
ParticipantsOG00212
Title
Measurements
OG0004103± 52
OG0017368± 46
OG0026949± 45
Cycle 3, Multiple Dose
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG00210
Title
Measurements
OG000
OG002
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Cycle 1, Single Dose
ParticipantsOG0002
ParticipantsOG00110
ParticipantsOG00212
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0017742± 47
OG0027411± 48
Cycle 3, Multiple Dose
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0027
Title
Measurements
OG000
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
Units
Counts
Participants
OG0003
OG00110
OG00212
Title
Denominators
Categories
Overall incidence of ADA
Title
Measurements
OG0001
OG0010
OG0020
Overall incidence of NAb
Title
Measurements
OG0001
OG0010
OG0020
Units
Counts
Participants
OG0006
OG00119
Title
Denominators
Categories
Title
Measurements
OG00033.3(4.3 to 77.7)
OG00126.3(9.1 to 51.2)
OG001
OVCA - Q2W Regimen
Participants with OVCA received PF-06647020 on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Units
Counts
Participants
OG0002
OG0015
Title
Denominators
Categories
Title
Measurements
OG000NA(3.7 to NA)NA indicates not calculable. Number of participants with confirmed objective response was too small to provide such summary statistics.
OG0016.5(3.9 to 8.3)
OVCA - Q2W Regimen
Participants with OVCA received PF-06647020 on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Units
Counts
Participants
OG0006
OG00119
Title
Denominators
Categories
Title
Measurements
OG00050(11.81 to 88.19)
OG00184.2(60.42 to 96.62)
Units
Counts
Participants
OG0006
OG00119
Title
Denominators
Categories
Title
Measurements
OG0002.7(1.0 to NA)NA indicates not calculable. Number of participants with PD was too small to provide such summary statistics.
OG0013.8(3.1 to 7.4)
Units
Counts
Participants
OG0006
OG00119
Title
Denominators
Categories
Title
Measurements
OG0002.7(1.0 to NA)NA indicates not calculable. Number of participants with PD or death was too small to provide such summary statistics.
OG0013.8(3.1 to 7.4)
0 affected
4 at risk
EG0043 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0081 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0072 affected10 at risk
EG0082 affected12 at risk
0 affected
4 at risk
EG0043 affected96 at risk
EG0051 affected6 at risk
EG0060 affected3 at risk
EG0071 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0043 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0071 affected10 at risk
EG0081 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
1 affected
4 at risk
EG0042 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0071 affected10 at risk
EG0081 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0043 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0081 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0043 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0081 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0042 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0042 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0045 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
1 affected
4 at risk
EG0040 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0071 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0081 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0051 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0041 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
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EG0060 affected3 at risk
EG0070 affected10 at risk
EG0081 affected12 at risk
0 affected
4 at risk
EG0040 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0071 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0040 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0071 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0040 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0071 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0040 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0071 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0040 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0081 affected12 at risk
0 affected
4 at risk
EG0040 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0071 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0040 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0071 affected10 at risk
EG0081 affected12 at risk
0 affected
4 at risk
EG0040 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0071 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0040 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0071 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0040 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0071 affected10 at risk
EG0082 affected12 at risk
0 affected
4 at risk
EG0040 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0081 affected12 at risk
0 affected
4 at risk
EG0040 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0071 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0040 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0081 affected12 at risk
0 affected
4 at risk
EG0040 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0081 affected12 at risk
0 affected
4 at risk
EG0040 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0081 affected12 at risk
0 affected
4 at risk
EG0040 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0071 affected10 at risk
EG0080 affected12 at risk
0 affected
4 at risk
EG0040 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0081 affected12 at risk
0 affected
4 at risk
EG0040 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0081 affected12 at risk
0 affected
4 at risk
EG0040 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0070 affected10 at risk
EG0081 affected12 at risk
0 affected
4 at risk
EG0040 affected96 at risk
EG0050 affected6 at risk
EG0060 affected3 at risk
EG0071 affected10 at risk
EG0080 affected12 at risk
65.4
± 7.8
0
BG00416
BG0050
BG0060
BG0070
BG0080
BG00916
3
BG00449
BG0054
BG0060
BG0070
BG0080
BG00959
1
BG00431
BG0052
BG0060
BG0070
BG0080
BG00937
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
0
BG0040
BG0050
BG0061
BG0075
BG0086
BG00912
0
BG0040
BG0050
BG0062
BG0075
BG0086
BG00913
16
BG0051
BG0060
BG0070
BG0080
BG00920
0
BG0040
BG0050
BG0063
BG00710
BG00811
BG00924
Male
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
BG0091
1
BG0050
BG0060
BG0070
BG0080
BG0091
0
BG0050
BG0060
BG0070
BG0080
BG0090
5
BG0050
BG0060
BG0070
BG0080
BG0096
88
BG0056
BG0060
BG0070
BG0080
BG009103
0
BG0050
BG0060
BG0070
BG0080
BG0090
2
BG0050
BG0060
BG0070
BG0080
BG0092
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
BG0091
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0071
BG0080
BG0091
White
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0062
BG0078
BG00811
BG00921
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0061
BG0071
BG0080
BG0092
72.3
± 23.4
27.2
± 8.7
1
OG00433
OG0052
1
OG0049
OG0050
2
OG00418
OG0051
1
OG00449
OG0055
0
OG00414
OG0050
0
OG0049
OG0050
0
OG0040
OG0050
1
OG00423
OG0051
3
OG00421
OG0051
0
OG00428
OG0053
0
OG00412
OG0050
0
OG0040
OG0050
0
OG0040
OG0050
0
OG00421
OG0052
0
OG00418
OG0051
0
OG0042
OG0050
0
OG0042
OG0050
0
OG0048
OG0051
0
OG0046
OG0050
0
OG0046
OG0050
0
OG0046
OG0050
0
OG0044
OG0050
0
OG0044
OG0050
0
OG0043
OG0050
0
OG0042
OG0050
0
OG0042
OG0050
0
OG0042
OG0050
0
OG0041
OG0050
0
OG0041
OG0050
0
OG0041
OG0050
OG0034570± 30
OG0044782± 61
OG0056929± 80
ParticipantsOG00441
ParticipantsOG0052
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0034201± 95
OG0045834± 60
OG005NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG00365.77± 25
OG00479.77± 45
OG00596.11± 47
ParticipantsOG00442
ParticipantsOG0052
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG00355.41± 53
OG00492.94± 50
OG005NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0030.03464± 27
OG0040.03956± 60
OG0050.03694± 72
ParticipantsOG00441
ParticipantsOG0052
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0030.03640± 42
OG0040.03121± 60
OG005NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0033.498± 26
OG0043.199± 40
OG0053.947± 52
ParticipantsOG00437
ParticipantsOG0052
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0033.230± 46
OG0042.808± 47
OG005NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0033.600± 0.487
OG0043.107± 1.161
OG0053.514± 0.696
ParticipantsOG00437
ParticipantsOG0052
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0034.013± 2.891
OG0044.007± 1.496
OG005NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0032.48(0.950 to 4.17)
OG0041.08(0.950 to 70.3)
OG0052.49(0.983 to 24.1)
ParticipantsOG00442
ParticipantsOG0052
Title
Measurements
OG000NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0033.05(0.967 to 24.0)
OG0041.65(0.917 to 48.2)
OG005NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0034570± 30
OG0044674± 63
OG0054450± 198
ParticipantsOG00442
ParticipantsOG0052
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0034157± 98
OG0045428± 83
OG005NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0034637± 30
OG0044829± 63
OG0057052± 81
ParticipantsOG00437
ParticipantsOG0052
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0034312± 102
OG0046086± 62
OG005NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG003844.6± 46
OG004803.9± 68
OG0051022± 78
ParticipantsOG00442
ParticipantsOG0052
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG003418.3± 106
OG004647.9± 46
OG005NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0037.156± 39
OG0046.934± 69
OG0057.660± 47
ParticipantsOG00442
ParticipantsOG0052
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0033.379± 84
OG0045.746± 60
OG005NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0033.150± 0.426
OG0042.881± 0.604
OG0053.210± 0.473
ParticipantsOG00440
ParticipantsOG0052
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0032.827± 0.391
OG0042.781± 0.676
OG005NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG00323.6(4.00 to 48.0)
OG00423.9(3.90 to 141)
OG00523.4(4.00 to 74.0)
ParticipantsOG00442
ParticipantsOG0052
Title
Measurements
OG000NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG00323.8(23.6 to 24.0)
OG00421.9(3.67 to 96.0)
OG005NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG003844.6± 46
OG004799.3± 68
OG005490.5± 615
ParticipantsOG00442
ParticipantsOG0052
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG003418.5± 106
OG004643.6± 48
OG005NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG003851.4± 45
OG004812.2± 68
OG0051020± 95
ParticipantsOG00440
ParticipantsOG0052
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG003422.9± 105
OG004645.2± 48
OG005NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0036968± 32
OG0045562± 62
OG0058451± 78
ParticipantsOG00441
ParticipantsOG0052
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0036122± 145
OG0046210± 80
OG005NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG00383.33± 20
OG00484.83± 43
OG00599.37± 47
ParticipantsOG00442
ParticipantsOG0052
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG00377.76± 76
OG00482.33± 40
OG005NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0034.505± 0.650
OG0043.674± 1.512
OG0054.386± 0.895
ParticipantsOG00437
ParticipantsOG0052
Title
Measurements
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0035.087± 2.626
OG0045.232± 2.259
OG005NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0034.00(0.950 to 4.17)
OG0043.70(0.933 to 24.1)
OG0052.31(0.983 to 4.00)
ParticipantsOG00442
ParticipantsOG0052
Title
Measurements
OG000NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0033.05(1.00 to 23.6)
OG0043.90(1.00 to 41.8)
OG005NA(NA to NA)NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0036969± 32
OG0045449± 64
OG0055247± 221
ParticipantsOG00442
ParticipantsOG0052
Title
Measurements
OG000NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0036127± 147
OG0045885± 97
OG005NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0037189± 32
OG0045608± 65
OG0058760± 80
ParticipantsOG00437
ParticipantsOG0052
Title
Measurements
OG002NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0036517± 156
OG0046191± 94
OG005NA± NANA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
0
OG00410
OG0050
ParticipantsOG00493
ParticipantsOG0055
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0049
OG0050
NA
± NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0019858± 21
OG0026933± 43
NA
± NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001114.7± 26
OG00281.91± 34
NA
± NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0012.349± 24
OG0023.106± 32
NA
± NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0010.02044± 25
OG0020.02688± 35
NA
± NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0013.633± 0.415
OG0023.600± 0.583
NA
(NA to NA)
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0011.07(0.983 to 23.9)
OG0022.36(0.983 to 4.03)
NA
± NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0019864± 20
OG0027000± 43
NA
± NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG00110570± 22
OG0027445± 44
NA
± NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001731.5± 61
OG002589.8± 33
NA
± NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0014.857± 66
OG0024.248± 34
NA
± NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0012.755± 0.653
OG0023.007± 0.373
NA
(NA to NA)
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG00171.7(3.75 to 166)
OG00222.8(3.75 to 48.3)
NA
± NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001728.9± 60
OG002593.3± 33
NA
± NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001738.8± 69
OG002617.9± 32
NA
± NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG00110440± 25
OG0028432± 42
NA
± NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG001106.6± 37
OG00289.66± 33
NA
± NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0014.734± 0.670
OG0024.124± 1.218
NA
(NA to NA)
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG0011.05(0.950 to 3.92)
OG0022.36(0.983 to 24.1)
NA
± NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
OG00110460± 24
OG0028555± 41
NA
± NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.