A Dose Escalation Study Of PF-06939999 In Participants Wi... | NCT03854227 | Trialant
NCT03854227
Sponsor
Pfizer
Status
Terminated
Last Update Posted
Jan 13, 2025Actual
Enrollment
54Actual
Phase
Phase 1
Conditions
Advanced Solid Tumors
Metastatic Solid Tumors
Interventions
PF-06939999 dose escalation
PF-06939999 monotherapy
PF-06939999 in combination with docetaxel
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03854227
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C3851001
Secondary IDs
Not provided
Brief Title
A Dose Escalation Study Of PF-06939999 In Participants With Advanced Or Metastatic Solid Tumors
Official Title
A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06939999 (PRMT5 INHIBITOR) IN PARTICIPANTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER, HEAD AND NECK SQUAMOUS CELL CARCINOMA, ESOPHAGEAL CANCER, ENDOMETRIAL CANCER, CERVICAL CANCER AND BLADDER CANCER
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Nov 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study has been terminated based on a strategic evaluation within the current Pfizer oncology portfolio. This decision is not due to any safety concerns or requests from any regulatory authorities.
Expanded Access Info
No
Start Date
Mar 14, 2019Actual
Primary Completion Date
Apr 27, 2022Actual
Completion Date
Apr 27, 2022Actual
First Submitted Date
Feb 15, 2019
First Submission Date that Met QC Criteria
Feb 22, 2019
First Posted Date
Feb 26, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Apr 24, 2023
Results First Submitted that Met QC Criteria
Nov 25, 2024
Results First Posted Date
Jan 13, 2025Actual
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
Nov 25, 2024
Last Update Posted Date
Jan 13, 2025Actual
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
This is a Phase 1, open label, multi center, dose escalation and expansion, safety, tolerability, PK, and pharmacodynamics study of PF 06939999 in previously treated patients with advanced or metastatic cancer.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Solid Tumors
Metastatic Solid Tumors
Keywords
Not provided
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
54Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Dose Escalation
Experimental
Participants will receive PF-06939999 orally at escalating doses in 28 day cycles on a continuous basis
Drug: PF-06939999 dose escalation
Non small cell lung cancer monotherapy
Experimental
Participants will receive PF-06939999 at the recommended Phase 2 dose in 28 day cycles on a continuous basis
Drug: PF-06939999 monotherapy
Urothelial carcinoma
Experimental
Participants will receive PF-06939999 at the recommended Phase 2 dose in 28 day cycles on a continuous basis
Drug: PF-06939999 monotherapy
Head and neck squamous cell carcinoma
Experimental
Participants will receive PF-06939999 at the recommended Phase 2 dose in 28 day cycles on a continuous basis
Drug: PF-06939999 monotherapy
Non small cell lung cancer PF-06939999 plus docetaxel
Experimental
Participants will receive PF-06939999 on a continuous basis in combination with docetaxel
Drug: PF-06939999 in combination with docetaxel
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-06939999 dose escalation
Drug
PF-06939999 orally at escalating doses on a continuous basis
Dose Escalation
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1A: Number of Participants With Dose-Limiting Toxicities (DLT)
DLTs=any of the following adverse events (AEs) occurring in the DLT observation period (first treatment cycle):1) Any Grade 4 hematologic AEs; Grade 4 neutropenia, febrile neutropenia, Grade 3 neutropenia with infection, Grade 3 thrombocytopenia with ≥Grade 2 clinically significant bleeding, Grade 3 anemia requiring blood transfusion; 2) Any Grade ≥3 non-hematologic AEs; Grade 3 nausea/vomiting or diarrhea lasting ≥4 days after treatment, confirmed drug induced liver injury meeting Hy's law criteria; a hepatic transaminase or alkaline phosphatase level >10 times the upper limit of normal for participants with Grade 2 hepatic transaminase or alkaline phosphatase levels at baseline as a result of liver/bone metastasis; clinically important or persistent toxicities; 3) Any toxicity causing >2 weeks of dose delay; 4) any dose reduction due to AE during the first cycle. Grades of AEs were defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Baseline through day 29.
Part 1A: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
An AE was any untoward medical occurrence in a participant who received study treatment 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. Grades of AEs were defined by NCI CTCAE version 5.0. Grade 3 events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 events = events that caused participant to be in imminent danger of death. Grade 5 events = death related to an AE.
Baseline up to a minimum of 28 days after last dose of study treatment (maximum of 13 months)
Part 1A: Number of Participants With Laboratory Abnormalities
Laboratory assessments included hematology, chemistry and urinary tests. Participants with maximum Grade 3-4 laboratory abnormalities are reported in this OM. Grades of laboratory results were defined by NCI CTCAE version 5.0. Grade 3 events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 events = events that caused participant to be in imminent danger of death. Some of the Grade 4 events (activated partial thromboplastin time prolonged, anemia, hemoglobin increased, leukocytosis, lymphocyte count increased and hypoalbuminemia) could not be defined/determined based only on lab data, therefore are not reported in this OM.
Secondary Outcomes
Measure
Description
Time Frame
Part 1A: PK Parameters of PF-06939999: Single Dose (SD) - Maximum Observed Plasma Concentration (Cmax)
Maximum plasma concentration of PF-06939999 after the participant received a SD on Cycle 1 Day 1. Cmax was directly observed from data.
Pre-dose and 0.5 hour, 1 hour, 2 hours, 4 hours, 6 hours and 12 hours post the morning dose on Cycle 1 Day 1.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed locally advanced or metastatic NSCLC, urothelial carcinoma or HNSCC
Progressed after at least 1 line of treatment and no more than 3 lines of treatment
At least one measurable lesion as defined by RECIST version 1.1
ECOG Performance Status 0 or 1
Adequate Bone Marrow Function
Adequate Renal Function
Adequate Liver Function
Resolved acute effects of any prior therapy
Exclusion Criteria:
Known active uncontrolled or symptomatic CNS metastases.
Major surgery, radiation therapy, systemic anti-cancer therapy or investigational drug(s) within 4 weeks prior to study entry.
Active, uncontrolled infection, including COVID-19
Known or suspected hypersensitivity to PF-06939999
Guo C, Liao KH, Li M, Wang IM, Shaik N, Yin D. PK/PD model-informed dose selection for oncology phase I expansion: Case study based on PF-06939999, a PRMT5 inhibitor. CPT Pharmacometrics Syst Pharmacol. 2023 Nov;12(11):1619-1625. doi: 10.1002/psp4.12882. Epub 2022 Nov 16.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
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
Twenty-eight participants were enrolled in the dose escalation part (Part 1A) and a 26 participants were enrolled in the dose expansion part (Part 2A, Part 2B and Part 2C). A total of 54 participants were assigned to treatment and treated. The study was terminated during dose expansion part due to strategy reason but not safety concerns. No enrollments occurred in Part 1B and Part 2D prior to study termination. In Part 2B, no enrollments occurred for the food-effect substudy.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1A: PF-06939999 0.5 mg Once Daily (QD)
Part 1 is dose escalation part. Participants received PF-06939999 0.5 mg QD in 28-day cycles up to 2 years or until disease progression.
FG001
Part 1A: PF-06939999 0.5 mg Twice Daily (BID)
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
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
Jun 11, 2020
Apr 24, 2023
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
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Dose Escalation and Dose expansion
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
Non small cell lung cancer dose finding
Experimental
Participants will receive PF-06939999 on a continuous basis at escalating doses in combination with docetaxel
Drug: PF-06939999 in combination with docetaxel
PRMT5 inhibitor
PF-06939999 monotherapy
Drug
PF-06939999 at the recommended Phase 2 dose orally on a continuous basis
Head and neck squamous cell carcinoma
Non small cell lung cancer monotherapy
Urothelial carcinoma
PRMT5 inhibitor
PF-06939999 in combination with docetaxel
Drug
PF-06939999 orally on a continuous basis in combination with docetaxel
Non small cell lung cancer PF-06939999 plus docetaxel
Non small cell lung cancer dose finding
PRMT5 inhibitor
Baseline up to a minimum of 28 days after last dose of study treatment (maximum of 12 months)
Part 2: Number of Participants With TEAEs
An AE was any untoward medical occurrence in a participant who received study treatment 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. Grades of AEs were defined by NCI CTCAE version 5.0. Grade 3 events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 events = events that caused participant to be in imminent danger of death. Grade 5 events = death related to an AE.
Baseline up to a minimum of 28 days after last dose of study treatment (maximum of 15 months)
Part 2: Number of Participants With Laboratory Abnormalities
Laboratory assessments included hematology, chemistry and urinary tests. Participants with maximum Grade 3-4 laboratory abnormalities are reported in this OM. Grades of laboratory results were defined by NCI CTCAE version 5.0. Grade 3 events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 events = events that caused participant to be in imminent danger of death. Some of the Grade 4 events (activated partial thromboplastin time prolonged, anemia, hemoglobin increased, leukocytosis, lymphocyte count increased and hypoalbuminemia) could not be defined/determined based only on lab data, therefore are not reported in this OM.
Baseline up to a minimum of 28 days after last dose of study treatment (maximum of 8 months)
Part 2: Number of Participants With Best Overall Response (BOR) Based on Investigator Assessment (RECIST, Version 1.1)
Number of participants with BOR assessed using Response Evaluation Criteria in Solid Tumor (RECIST) v1.1: Complete Response (CR): disappearance of all lesions (with the exception of nodal disease when assessing target lesions). Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered a sign of progression. Stable disease (SD): does not qualify for CR, PR or PD. Non-CR/Non-PD: Persistence of any non target lesions and/or tumor marker level above the normal limits.
From baseline up to 28 ~ 35 days after end of treatment (maximum of 6 months).
Part 1A: PK Parameters of PF-06939999: SD - Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time to maximum plasma concentration of PF-06939999 after the participant received a SD on Cycle 1 Day 1. Tmax was observed directly from data.
Predose, 0.5, 1, 2, 4, 6 and 12 hours post the morning dose on Cycle 1 Day 1.
Part 1A: PK Parameters of PF-06939999: SD - Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration versus time curve (AUC) from time 0 to the last measured concentration (AUClast) after the participant received a SD of PF-06939999 on Cycle 1 Day 1.
Predose, 0.5, 1, 2, 4, 6 and 12 hours post the morning dose on Cycle 1 Day 1.
Part 1A: PK Parameters of PF-06939999: Multiple Dose (MD) - Steady State Maximum Observed Plasma Concentration (Cmax,ss)
Cmax,ss was the steady-state maximum concentration of PF-06939999 after MD. Cmax,ss was observed directly from the data.
Predose, 0.5, 1, 2, 4, 6 and 12 hours post the morning dose on Cycle 1 Day 15.
Part 1A: PK Parameters of PF-06939999: MD - Steady State Time to Reach Maximum Observed Plasma Concentration (Tmax,ss)
Tmax,ss was the steady-state time to maximum plasma concentration of PF-06939999 after MD. Tmax,ss was observed directly from data.
Predose, 0.5, 1, 2, 4, 6 and 12 hours post the morning dose on Cycle 1 Day 15.
Part 1A: PK Parameters of PF-06939999: MD - Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau,ss)
AUCtau,ss was the steady-state area under the concentration-time profile from time zero to time tau (Ï„) of PF-06939999 after MD.
Predose, 0.5, 1, 2, 4, 6 and 12 hours post the morning dose on Cycle 1 Day 15.
Part 1A: PK Parameters of PF-06939999: MD - Apparent Oral Clearance (CL/F)
Apparent oral plasma clearance of PF-06939999 after MD. CL/F after multiple doses = Dose/AUCtau,ss. AUCtau,ss = area under the concentration-time profile from time zero to time tau after multiple doses.
Predose, 0.5, 1, 2, 4, 6 and 12 hours post the morning dose on Cycle 1 Day 15.
Part 1A: PK Parameters of PF-06939999: MD - Accumulation Ratio (Rac)
Rac was observed accumulation ratio based on AUCtau. Rac was calculated as AUCtau (multiple dose, Cycle 1 Day 15)/ AUCtau (single dose, Cycle 1 Day 1). AUCtau was area under the concentration-time profile from time zero to time tau (Ï„), the dosing interval.
Pre-dose and 0.5 hour, 1 hour, 2 hours, 4 hours, 6 hours and 12 hours post the morning dose on Cycle 1 Day 1; Pre-dose and 0.5, 1, 2, 4, 6 and 12 hours post the morning dose on Cycle 1 Day 15.
Part 2: PK Parameters of PF-06939999: SD - Cmax
Maximum plasma concentration of PF-06939999 after the participant received a SD on Cycle 1 Day 1. Cmax was directly observed from data.
Pre-dose and 0.5 hour, 1 hour, 2 hours and 4 hours post Cycle 1 Day 1 dosing.
Part 2: PK Parameters of PF-06939999: SD - Tmax
Time to maximum plasma concentration of PF-06939999 after the participant received a SD on Cycle 1 Day 1. Tmax was observed directly from data.
Pre-dose and 0.5 hour, 1 hour, 2 hours and 4 hours post Cycle 1 Day 1 dosing.
Part 2: PK Parameters of PF-06939999: MD - Cmax,ss
Cmax,ss was the steady-state maximum concentration of PF-06939999 after MD. Cmax,ss was observed directly from the data.
Pre-dose and 0.5 hour, 1 hour, 2 hours and 4 hours post Cycle 1 Day 15 dosing.
Part 2: PK Parameters of PF-06939999: MD - Tmax,ss
Tmax,ss was the steady-state time to maximum plasma concentration of PF-06939999 after MD. Tmax,ss was observed directly from data.
Pre-dose and 0.5 hour, 1 hour, 2 hours and 4 hours post Cycle 1 Day 15 dosing.
Part 2: PK Parameters of PF-06939999: MD - Trough Concentration (Ctrough).
Ctrough was trough serum concentration of PF-06939999 after MD. Ctrough = Cmin.
Pre-dose and 0.5 hour, 1 hour, 2 hours and 4 hours post Cycle 1 Day 15 dosing.
Part 2B: PK Parameters of PF-06939999 Given With and Without Food - Cmax
Maximum concentration of PF-06939999 given with and without food. On Cycle 1 Day 15, participants enrolled in the food-effect substudy of Part 2B received an oral dose of PF-06939999 under the fasted condition (overnight fasting of at least 10 hours; water permitted). On Cycle 1 Day 16, these participants received another oral dose of PF-06939999 with a high-fat, high-calorie meal (breakfast) following 10-hour overnight fasting (water permitted).
Predose and 0.5, 1, 2, 4, 6 and 12 hours post dose on Cycle 1 Day 15 (fasted condition); predose and 0.5, 1, 2, 4, 6 and 12 hours post dose on Cycle 1 Day 16 (with food).
Part 2B: PK Parameters of PF-06939999 Given With and Without Food - Tmax
Time to maximum plasma concentration of PF-06939999 given with and without food. On Cycle 1 Day 15, participants enrolled in the food-effect substudy of Part 2B received an oral dose of PF-06939999 under the fasted condition (overnight fasting of at least 10 hours; water permitted). On Cycle 1 Day 16, these participants received another oral dose of PF-06939999 with a high-fat, high-calorie meal (breakfast) following 10-hour overnight fasting (water permitted).
Predose and 0.5, 1, 2, 4, 6 and 12 hours post dose on Cycle 1 Day 15 (fasted condition); predose and 0.5, 1, 2, 4, 6 and 12 hours post dose on Cycle 1 Day 16 (with food).
Part 2B: PK Parameters of PF-06939999 Given With and Without Food - AUClast
AUClast of PF-06939999 given with and without food. On Cycle 1 Day 15, participants enrolled in the food-effect substudy of Part 2B received an oral dose of PF-06939999 under the fasted condition (overnight fasting of at least 10 hours; water permitted). On Cycle 1 Day 16, these participants received another oral dose of PF-06939999 with a high-fat, high-calorie meal (breakfast) following 10-hour overnight fasting (water permitted).
Predose and 0.5, 1, 2, 4, 6 and 12 hours post dose on Cycle 1 Day 15 (fasted condition); predose and 0.5, 1, 2, 4, 6 and 12 hours post dose on Cycle 1 Day 16 (with food).
Part 1A: Percentage of Participants With Objective Response Based on Investigator Assessment (RECIST v1.1)
Objective Response Rate (ORR) was defined as the percentage of participants who achieved CR or PR per RECIST 1.1. CR was defined as disappearance of all lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From baseline up to 28 ~ 35 days after end of treatment (maximum of 12 months).
Part 1A: Duration of Response Based on Investigator Assessment (RECIST, v1.1)
Duration of response was defined as the time from start date (which is the date of first documentation of PR or CR) to date of first documentation of objective progression or death. DOR was only applicable to those participants with an objective response (confirmed CR or PR). CR: disappearance of all lesions (with the exception of nodal disease when assessing target lesions). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From baseline up to 28 ~ 35 days after end of treatment (maximum of 12 months).
Part 2: Duration of Response Based on Investigator Assessment (RECIST, v1.1)
Duration of response was defined as the time from start date (which is the date of first documentation of PR or CR) to date of first documentation of objective progression or death. DoR was only applicable to those participants with an objective response (confirmed CR or PR). CR: disappearance of all lesions (with the exception of nodal disease when assessing target lesions). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From baseline up to 28 ~ 35 days after end of treatment (maximum of 6 months).
Part 2: Progression Free Survival Based on Investigator Assessment (RECIST, v1.1)
Progression Free Survival (PFS) was defined as the time from initiation of PF-06939999 therapy to first documentation of tumor progression or to death due to any cause, whichever occurred first.
From baseline up to 28 ~ 35 days after end of treatment (maximum of 6 months).
Part 2: Time to Progression Based on Investigator Assessment (RECIST, v1.1)
Time to Progression (TTP) was defined as the time from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to tumor progression. Disease progression is defined using RECIST v 1.1.
From baseline up to 28 ~ 35 days after end of treatment (maximum of 6 months).
Part 2: Overall Survival
Overall Survival (OS) was defined as the time from the start date (first dose) of study treatment to the date of death due to any cause.
From baseline up to maximum follow up (15 months).
Part 2: Probability of Survival at 6 Months and 1 Year of PF-06939999 Monotherapy
The probability of survival at select times was estimated using the Kaplan Meier method. Although an endpoint of Overall Survival at 2 years of study treatment was defined in the protocol, no data were collected/analyzed for this endpoint due to maximum follow up not reaching 2 year post study treatment.
From baseline up to maximum follow up (15 months).
Scottsdale
Arizona
85258
United States
Keck Hospital of USC
Los Angeles
California
90033
United States
LAC + USC Medical Center
Los Angeles
California
90033
United States
USC Norris Comprehensive Cancer Center
Los Angeles
California
90033
United States
USC/Norris Comprehensive Cancer Center
Los Angeles
California
90033
United States
Keck Medical Center of USC Pasadena
Pasadena
California
91105
United States
AdventHealth Celebration Infusion Center
Celebration
Florida
34747
United States
AdventHealth Medical Group Oncology Research at Celebration
Celebration
Florida
34747
United States
University Of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center
Miami
Florida
33136
United States
AdventHealth Orlando - Investigational Drug Services
Orlando
Florida
32804
United States
AdventHealth Orlando Infusion Center
Orlando
Florida
32804
United States
AdventHealth Orlando
Orlando
Florida
32804
United States
St. Joseph Mercy Hospital
Ann Arbor
Michigan
48106
United States
St. Joseph Mercy Brighton
Brighton
Michigan
48114
United States
Henry-Joyce Cancer Clinic
Nashville
Tennessee
37232
United States
Oncology IDS Pharmacy
Nashville
Tennessee
37232
United States
The University of Texas
Houston
Texas
77030
United States
NEXT Oncology
San Antonio
Texas
78229
United States
Inova Schar Cancer Institute
Fairfax
Virginia
22031
United States
Seattle Cancer Care Alliance
Seattle
Washington
98109
United States
University of Washington Medical Center
Seattle
Washington
98195
United States
Participants received PF-06939999 0.5 mg BID in 28-day cycles up to 2 years or until disease progression.
FG002
Part 1A: PF-06939999 1 mg BID
Participants received PF-06939999 1 mg BID in 28-day cycles up to 2 years or until disease progression.
FG003
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
FG004
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
FG005
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
FG006
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
FG007
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
FG008
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
FG009
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
FG010
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin [MVAC]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
FG011
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0033 subjects
FG0043 subjects
FG0054 subjects
FG0063 subjects
FG0076 subjects
FG0085 subjects
FG00914 subjects
FG0102 subjects
FG01110 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0033 subjects
FG0043 subjects
FG0054 subjects
FG0063 subjects
FG0076 subjects
FG0085 subjects
FG00914 subjects
FG0102 subjects
FG01110 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0093 subjects
FG0100 subjects
FG0111 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive disease
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
Study terminated by sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Disease relapse
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Global deterioration of health status
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Refused further treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Baseline analysis population included all enrolled participants who received at least 1 dose of study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1A: PF-06939999 0.5 mg QD
Part 1 is dose escalation part. Participants received PF-06939999 0.5 mg QD in 28-day cycles up to 2 years or until disease progression.
BG001
Part 1A: PF-06939999 0.5 mg BID
Participants received PF-06939999 0.5 mg BID in 28-day cycles up to 2 years or until disease progression.
BG002
Part 1A: PF-06939999 1 mg BID
Participants received PF-06939999 1 mg BID in 28-day cycles up to 2 years or until disease progression.
BG003
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
BG004
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
BG005
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
BG006
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
BG007
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
BG008
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
BG009
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
BG010
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin [MVAC]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
BG011
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0011
BG0022
BG0033
BG0043
BG0054
BG0063
BG0076
BG0085
BG00914
BG0102
BG01110
BG01254
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00081.00
BG00154.00
BG00265.00± 5.66
BG003
Age, Continuous
Median
Full Range
Years
Title
Denominators
Categories
Title
Measurements
BG00081.00(81 to 81)
BG00154.00(54 to 54)
BG002
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
<18 years
Title
Measurements
BG0000
BG0010
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
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
Part 1A: Number of Participants With Dose-Limiting Toxicities (DLT)
DLTs=any of the following adverse events (AEs) occurring in the DLT observation period (first treatment cycle):1) Any Grade 4 hematologic AEs; Grade 4 neutropenia, febrile neutropenia, Grade 3 neutropenia with infection, Grade 3 thrombocytopenia with ≥Grade 2 clinically significant bleeding, Grade 3 anemia requiring blood transfusion; 2) Any Grade ≥3 non-hematologic AEs; Grade 3 nausea/vomiting or diarrhea lasting ≥4 days after treatment, confirmed drug induced liver injury meeting Hy's law criteria; a hepatic transaminase or alkaline phosphatase level >10 times the upper limit of normal for participants with Grade 2 hepatic transaminase or alkaline phosphatase levels at baseline as a result of liver/bone metastasis; clinically important or persistent toxicities; 3) Any toxicity causing >2 weeks of dose delay; 4) any dose reduction due to AE during the first cycle. Grades of AEs were defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
The analysis population included participants in Part 1A who had at least one dose of study treatment and either experienced DLT or did not have major treatment deviations during the DLT observation period.
Posted
Count of Participants
Participants
Baseline through day 29.
ID
Title
Description
OG000
Part 1A: PF-06939999 0.5 mg QD
Part 1 is dose escalation part. Participants received PF-06939999 0.5 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 1A: PF-06939999 0.5 mg BID
Participants received PF-06939999 0.5 mg BID in 28-day cycles up to 2 years or until disease progression.
OG002
Part 1A: PF-06939999 1 mg BID
Participants received PF-06939999 1 mg BID in 28-day cycles up to 2 years or until disease progression.
OG003
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
OG004
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
OG005
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
OG006
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
OG007
Part 1A: PF-06939999 6 mg QD
Units
Counts
Participants
OG0001
OG0011
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 1A: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
An AE was any untoward medical occurrence in a participant who received study treatment 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. Grades of AEs were defined by NCI CTCAE version 5.0. Grade 3 events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 events = events that caused participant to be in imminent danger of death. Grade 5 events = death related to an AE.
The analysis set included all participants in Part 1A who received at least 1 dose of study treatment.
Posted
Count of Participants
Participants
Baseline up to a minimum of 28 days after last dose of study treatment (maximum of 13 months)
ID
Title
Description
OG000
Part 1A: PF-06939999 0.5 mg QD
Part 1 is dose escalation part. Participants received PF-06939999 0.5 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 1A: PF-06939999 0.5 mg BID
Participants received PF-06939999 0.5 mg BID in 28-day cycles up to 2 years or until disease progression.
Primary
Part 1A: Number of Participants With Laboratory Abnormalities
Laboratory assessments included hematology, chemistry and urinary tests. Participants with maximum Grade 3-4 laboratory abnormalities are reported in this OM. Grades of laboratory results were defined by NCI CTCAE version 5.0. Grade 3 events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 events = events that caused participant to be in imminent danger of death. Some of the Grade 4 events (activated partial thromboplastin time prolonged, anemia, hemoglobin increased, leukocytosis, lymphocyte count increased and hypoalbuminemia) could not be defined/determined based only on lab data, therefore are not reported in this OM.
The analysis set included all participants in Part 1A who received at least 1 dose of study treatment. Number of Participants Analyzed = number of participants evaluable for this outcome measure. Number Analyzed = number of participants evaluable for the specific laboratory test.
Posted
Count of Participants
Participants
Baseline up to a minimum of 28 days after last dose of study treatment (maximum of 12 months)
ID
Title
Description
OG000
Part 1A: PF-06939999 0.5 mg QD
Part 1 is dose escalation part. Participants received PF-06939999 0.5 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 1A: PF-06939999 0.5 mg BID
Participants received PF-06939999 0.5 mg BID in 28-day cycles up to 2 years or until disease progression.
Primary
Part 2: Number of Participants With TEAEs
An AE was any untoward medical occurrence in a participant who received study treatment 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. Grades of AEs were defined by NCI CTCAE version 5.0. Grade 3 events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 events = events that caused participant to be in imminent danger of death. Grade 5 events = death related to an AE.
The analysis set included all participants in Part 2 who received at least 1 dose of study treatment.
Posted
Count of Participants
Participants
Baseline up to a minimum of 28 days after last dose of study treatment (maximum of 15 months)
ID
Title
Description
OG000
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Primary
Part 2: Number of Participants With Laboratory Abnormalities
Laboratory assessments included hematology, chemistry and urinary tests. Participants with maximum Grade 3-4 laboratory abnormalities are reported in this OM. Grades of laboratory results were defined by NCI CTCAE version 5.0. Grade 3 events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 events = events that caused participant to be in imminent danger of death. Some of the Grade 4 events (activated partial thromboplastin time prolonged, anemia, hemoglobin increased, leukocytosis, lymphocyte count increased and hypoalbuminemia) could not be defined/determined based only on lab data, therefore are not reported in this OM.
The analysis set included all participants in Part 2 who received at least 1 dose of study treatment. Number of Participants Analyzed = number of participants evaluable for this outcome measure. Number Analyzed = number of participants evaluable for the specific laboratory test.
Posted
Count of Participants
Participants
Baseline up to a minimum of 28 days after last dose of study treatment (maximum of 8 months)
ID
Title
Description
OG000
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Primary
Part 2: Number of Participants With Best Overall Response (BOR) Based on Investigator Assessment (RECIST, Version 1.1)
Number of participants with BOR assessed using Response Evaluation Criteria in Solid Tumor (RECIST) v1.1: Complete Response (CR): disappearance of all lesions (with the exception of nodal disease when assessing target lesions). Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered a sign of progression. Stable disease (SD): does not qualify for CR, PR or PD. Non-CR/Non-PD: Persistence of any non target lesions and/or tumor marker level above the normal limits.
The analysis population included all participants in Part 2 who received at least one dose of study treatment and had baseline disease assessment or measurable disease at baseline, if applicable and at least one post baseline disease assessment.
Posted
Count of Participants
Participants
From baseline up to 28 ~ 35 days after end of treatment (maximum of 6 months).
ID
Title
Description
OG000
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Secondary
Part 1A: PK Parameters of PF-06939999: Single Dose (SD) - Maximum Observed Plasma Concentration (Cmax)
Maximum plasma concentration of PF-06939999 after the participant received a SD on Cycle 1 Day 1. Cmax was directly observed from data.
The analysis population included enrolled participants in Part 1A treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram per milliliter (ng/mL)
Pre-dose and 0.5 hour, 1 hour, 2 hours, 4 hours, 6 hours and 12 hours post the morning dose on Cycle 1 Day 1.
ID
Title
Description
OG000
Part 1A: PF-06939999 0.5 mg QD
Part 1 is dose escalation part. Participants received PF-06939999 0.5 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 1A: PF-06939999 0.5 mg BID
Participants received PF-06939999 0.5 mg BID in 28-day cycles up to 2 years or until disease progression.
OG002
Part 1A: PF-06939999 1 mg BID
Participants received PF-06939999 1 mg BID in 28-day cycles up to 2 years or until disease progression.
Secondary
Part 1A: PK Parameters of PF-06939999: SD - Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time to maximum plasma concentration of PF-06939999 after the participant received a SD on Cycle 1 Day 1. Tmax was observed directly from data.
The analysis population included enrolled participants in Part 1A treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest.
Posted
Median
Full Range
hours (hr)
Predose, 0.5, 1, 2, 4, 6 and 12 hours post the morning dose on Cycle 1 Day 1.
ID
Title
Description
OG000
Part 1A: PF-06939999 0.5 mg QD
Part 1 is dose escalation part. Participants received PF-06939999 0.5 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 1A: PF-06939999 0.5 mg BID
Participants received PF-06939999 0.5 mg BID in 28-day cycles up to 2 years or until disease progression.
OG002
Part 1A: PF-06939999 1 mg BID
Participants received PF-06939999 1 mg BID in 28-day cycles up to 2 years or until disease progression.
OG003
Secondary
Part 1A: PK Parameters of PF-06939999: SD - Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration versus time curve (AUC) from time 0 to the last measured concentration (AUClast) after the participant received a SD of PF-06939999 on Cycle 1 Day 1.
The analysis population included enrolled participants in Part 1A treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest with evaluable data that contributed to the summary statistics of this outcome measure (OM).
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram*hour per milliliter (ng*hr/mL)
Predose, 0.5, 1, 2, 4, 6 and 12 hours post the morning dose on Cycle 1 Day 1.
ID
Title
Description
OG000
Part 1A: PF-06939999 0.5 mg QD
Part 1 is dose escalation part. Participants received PF-06939999 0.5 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 1A: PF-06939999 0.5 mg BID
Participants received PF-06939999 0.5 mg BID in 28-day cycles up to 2 years or until disease progression.
OG002
Part 1A: PF-06939999 1 mg BID
Participants received PF-06939999 1 mg BID in 28-day cycles up to 2 years or until disease progression.
Secondary
Part 1A: PK Parameters of PF-06939999: Multiple Dose (MD) - Steady State Maximum Observed Plasma Concentration (Cmax,ss)
Cmax,ss was the steady-state maximum concentration of PF-06939999 after MD. Cmax,ss was observed directly from the data.
The analysis population included enrolled participants in Part 1A treated who did not had protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest, with evaluable data that contributed to the summary statistics of this OM.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Predose, 0.5, 1, 2, 4, 6 and 12 hours post the morning dose on Cycle 1 Day 15.
ID
Title
Description
OG000
Part 1A: PF-06939999 0.5 mg QD
Part 1 is dose escalation part. Participants received PF-06939999 0.5 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 1A: PF-06939999 0.5 mg BID
Participants received PF-06939999 0.5 mg BID in 28-day cycles up to 2 years or until disease progression.
OG002
Part 1A: PF-06939999 1 mg BID
Participants received PF-06939999 1 mg BID in 28-day cycles up to 2 years or until disease progression.
Secondary
Part 1A: PK Parameters of PF-06939999: MD - Steady State Time to Reach Maximum Observed Plasma Concentration (Tmax,ss)
Tmax,ss was the steady-state time to maximum plasma concentration of PF-06939999 after MD. Tmax,ss was observed directly from data.
The analysis population included enrolled participants in Part 1A treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest, with evaluable data that contributed to the summary statistics of this OM.
Posted
Median
Full Range
hr
Predose, 0.5, 1, 2, 4, 6 and 12 hours post the morning dose on Cycle 1 Day 15.
ID
Title
Description
OG000
Part 1A: PF-06939999 0.5 mg QD
Part 1 is dose escalation part. Participants received PF-06939999 0.5 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 1A: PF-06939999 0.5 mg BID
Participants received PF-06939999 0.5 mg BID in 28-day cycles up to 2 years or until disease progression.
OG002
Part 1A: PF-06939999 1 mg BID
Participants received PF-06939999 1 mg BID in 28-day cycles up to 2 years or until disease progression.
Secondary
Part 1A: PK Parameters of PF-06939999: MD - Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau,ss)
AUCtau,ss was the steady-state area under the concentration-time profile from time zero to time tau (Ï„) of PF-06939999 after MD.
The analysis population included enrolled participants in Part 1A treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest, with evaluable data that contributed to the summary statistics of this OM.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL
Predose, 0.5, 1, 2, 4, 6 and 12 hours post the morning dose on Cycle 1 Day 15.
ID
Title
Description
OG000
Part 1A: PF-06939999 0.5 mg QD
Part 1 is dose escalation part. Participants received PF-06939999 0.5 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 1A: PF-06939999 0.5 mg BID
Participants received PF-06939999 0.5 mg BID in 28-day cycles up to 2 years or until disease progression.
OG002
Part 1A: PF-06939999 1 mg BID
Participants received PF-06939999 1 mg BID in 28-day cycles up to 2 years or until disease progression.
Secondary
Part 1A: PK Parameters of PF-06939999: MD - Apparent Oral Clearance (CL/F)
Apparent oral plasma clearance of PF-06939999 after MD. CL/F after multiple doses = Dose/AUCtau,ss. AUCtau,ss = area under the concentration-time profile from time zero to time tau after multiple doses.
The analysis population included enrolled participants in Part 1A treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest, with evaluable data that contributed to the summary statistics of this OM.
Posted
Geometric Mean
Geometric Coefficient of Variation
liters per hour (L/hr)
Predose, 0.5, 1, 2, 4, 6 and 12 hours post the morning dose on Cycle 1 Day 15.
ID
Title
Description
OG000
Part 1A: PF-06939999 0.5 mg QD
Part 1 is dose escalation part. Participants received PF-06939999 0.5 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 1A: PF-06939999 0.5 mg BID
Participants received PF-06939999 0.5 mg BID in 28-day cycles up to 2 years or until disease progression.
OG002
Part 1A: PF-06939999 1 mg BID
Participants received PF-06939999 1 mg BID in 28-day cycles up to 2 years or until disease progression.
Secondary
Part 1A: PK Parameters of PF-06939999: MD - Accumulation Ratio (Rac)
Rac was observed accumulation ratio based on AUCtau. Rac was calculated as AUCtau (multiple dose, Cycle 1 Day 15)/ AUCtau (single dose, Cycle 1 Day 1). AUCtau was area under the concentration-time profile from time zero to time tau (Ï„), the dosing interval.
The analysis population included enrolled participants in Part 1A treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest, and contributed to the summary statistics of this OM.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Pre-dose and 0.5 hour, 1 hour, 2 hours, 4 hours, 6 hours and 12 hours post the morning dose on Cycle 1 Day 1; Pre-dose and 0.5, 1, 2, 4, 6 and 12 hours post the morning dose on Cycle 1 Day 15.
ID
Title
Description
OG000
Part 1A: PF-06939999 0.5 mg QD
Part 1 is dose escalation part. Participants received PF-06939999 0.5 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 1A: PF-06939999 0.5 mg BID
Participants received PF-06939999 0.5 mg BID in 28-day cycles up to 2 years or until disease progression.
OG002
Part 1A: PF-06939999 1 mg BID
Secondary
Part 2: PK Parameters of PF-06939999: SD - Cmax
Maximum plasma concentration of PF-06939999 after the participant received a SD on Cycle 1 Day 1. Cmax was directly observed from data.
The analysis population included enrolled participants in Part 2 treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest, with evaluable data that contributed to the summary statistics of this OM.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose and 0.5 hour, 1 hour, 2 hours and 4 hours post Cycle 1 Day 1 dosing.
ID
Title
Description
OG000
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin [MVAC]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Secondary
Part 2: PK Parameters of PF-06939999: SD - Tmax
Time to maximum plasma concentration of PF-06939999 after the participant received a SD on Cycle 1 Day 1. Tmax was observed directly from data.
The analysis population included enrolled participants in Part 2 treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest, with evaluable data that contributed to the summary statistics of this OM.
Posted
Median
Full Range
hr
Pre-dose and 0.5 hour, 1 hour, 2 hours and 4 hours post Cycle 1 Day 1 dosing.
ID
Title
Description
OG000
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin [MVAC]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Secondary
Part 2: PK Parameters of PF-06939999: MD - Cmax,ss
Cmax,ss was the steady-state maximum concentration of PF-06939999 after MD. Cmax,ss was observed directly from the data.
The analysis population included enrolled participants in Part 2 treated who did not have protocol deviations influencing PK assessment, and have sufficient information to estimate at least 1 of the PK parameters of interest, with evaluable data that contributed to the summary statistics of this OM.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose and 0.5 hour, 1 hour, 2 hours and 4 hours post Cycle 1 Day 15 dosing.
ID
Title
Description
OG000
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin [MVAC]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Secondary
Part 2: PK Parameters of PF-06939999: MD - Tmax,ss
Tmax,ss was the steady-state time to maximum plasma concentration of PF-06939999 after MD. Tmax,ss was observed directly from data.
The analysis population included enrolled participants in Part 2 treated who did not have protocol deviations influencing PK assessment, and have sufficient information to estimate at least 1 of the PK parameters of interest, with evaluable data that contributed to the summary statistics of this OM.
Posted
Median
Full Range
hr
Pre-dose and 0.5 hour, 1 hour, 2 hours and 4 hours post Cycle 1 Day 15 dosing.
ID
Title
Description
OG000
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin [MVAC]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Secondary
Part 2: PK Parameters of PF-06939999: MD - Trough Concentration (Ctrough).
Ctrough was trough serum concentration of PF-06939999 after MD. Ctrough = Cmin.
The analysis population included enrolled participants in Part 2 treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest, with evaluable data that contributed to the summary statistics of this OM.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose and 0.5 hour, 1 hour, 2 hours and 4 hours post Cycle 1 Day 15 dosing.
ID
Title
Description
OG000
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin [MVAC]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Secondary
Part 2B: PK Parameters of PF-06939999 Given With and Without Food - Cmax
Maximum concentration of PF-06939999 given with and without food. On Cycle 1 Day 15, participants enrolled in the food-effect substudy of Part 2B received an oral dose of PF-06939999 under the fasted condition (overnight fasting of at least 10 hours; water permitted). On Cycle 1 Day 16, these participants received another oral dose of PF-06939999 with a high-fat, high-calorie meal (breakfast) following 10-hour overnight fasting (water permitted).
The analysis population included participants enrolled and treated in the food-effect substudy of Part 2B who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest. Food-effect cohort in Part 2B was not enrolled.
Posted
Predose and 0.5, 1, 2, 4, 6 and 12 hours post dose on Cycle 1 Day 15 (fasted condition); predose and 0.5, 1, 2, 4, 6 and 12 hours post dose on Cycle 1 Day 16 (with food).
ID
Title
Description
OG000
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin [MVAC]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Secondary
Part 2B: PK Parameters of PF-06939999 Given With and Without Food - Tmax
Time to maximum plasma concentration of PF-06939999 given with and without food. On Cycle 1 Day 15, participants enrolled in the food-effect substudy of Part 2B received an oral dose of PF-06939999 under the fasted condition (overnight fasting of at least 10 hours; water permitted). On Cycle 1 Day 16, these participants received another oral dose of PF-06939999 with a high-fat, high-calorie meal (breakfast) following 10-hour overnight fasting (water permitted).
The analysis population included participants enrolled and treated in the food-effect substudy of Part 2B who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest. Food-effect cohort in Part 2B was not enrolled.
Posted
Predose and 0.5, 1, 2, 4, 6 and 12 hours post dose on Cycle 1 Day 15 (fasted condition); predose and 0.5, 1, 2, 4, 6 and 12 hours post dose on Cycle 1 Day 16 (with food).
ID
Title
Description
OG000
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin [MVAC]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Secondary
Part 2B: PK Parameters of PF-06939999 Given With and Without Food - AUClast
AUClast of PF-06939999 given with and without food. On Cycle 1 Day 15, participants enrolled in the food-effect substudy of Part 2B received an oral dose of PF-06939999 under the fasted condition (overnight fasting of at least 10 hours; water permitted). On Cycle 1 Day 16, these participants received another oral dose of PF-06939999 with a high-fat, high-calorie meal (breakfast) following 10-hour overnight fasting (water permitted).
The analysis population included participants enrolled and treated in the food-effect substudy of Part 2B who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest. Food-effect cohort in Part 2B was not enrolled.
Posted
Predose and 0.5, 1, 2, 4, 6 and 12 hours post dose on Cycle 1 Day 15 (fasted condition); predose and 0.5, 1, 2, 4, 6 and 12 hours post dose on Cycle 1 Day 16 (with food).
ID
Title
Description
OG000
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin [MVAC]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Secondary
Part 1A: Percentage of Participants With Objective Response Based on Investigator Assessment (RECIST v1.1)
Objective Response Rate (ORR) was defined as the percentage of participants who achieved CR or PR per RECIST 1.1. CR was defined as disappearance of all lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
The analysis population included all participants in Part 1A who received at least one dose of study treatment and had baseline disease assessment or measurable disease at baseline, if applicable and at least one post baseline disease assessment.
Posted
Number
95% Confidence Interval
Percentage of participants
From baseline up to 28 ~ 35 days after end of treatment (maximum of 12 months).
ID
Title
Description
OG000
Part 1A: PF-06939999 0.5 mg QD
Part 1 is dose escalation part. Participants received PF-06939999 0.5 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 1A: PF-06939999 0.5 mg BID
Participants received PF-06939999 0.5 mg BID in 28-day cycles up to 2 years or until disease progression.
OG002
Part 1A: PF-06939999 1 mg BID
Participants received PF-06939999 1 mg BID in 28-day cycles up to 2 years or until disease progression.
Secondary
Part 1A: Duration of Response Based on Investigator Assessment (RECIST, v1.1)
Duration of response was defined as the time from start date (which is the date of first documentation of PR or CR) to date of first documentation of objective progression or death. DOR was only applicable to those participants with an objective response (confirmed CR or PR). CR: disappearance of all lesions (with the exception of nodal disease when assessing target lesions). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
The analysis population included all participants in Part 1A who received at least one dose of study treatment and had baseline disease assessment or measurable disease at baseline, if applicable and at least one post baseline disease assessment, with confirmed CR or PR.
Posted
Median
95% Confidence Interval
Months
From baseline up to 28 ~ 35 days after end of treatment (maximum of 12 months).
ID
Title
Description
OG000
Part 1A: PF-06939999 0.5 mg QD
Part 1 is dose escalation part. Participants received PF-06939999 0.5 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 1A: PF-06939999 0.5 mg BID
Participants received PF-06939999 0.5 mg BID in 28-day cycles up to 2 years or until disease progression.
OG002
Secondary
Part 2: Duration of Response Based on Investigator Assessment (RECIST, v1.1)
Duration of response was defined as the time from start date (which is the date of first documentation of PR or CR) to date of first documentation of objective progression or death. DoR was only applicable to those participants with an objective response (confirmed CR or PR). CR: disappearance of all lesions (with the exception of nodal disease when assessing target lesions). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
The analysis population included all participants in Part 2 who received at least one dose of study treatment and had baseline disease assessment or measurable disease at baseline, if applicable and at least one post baseline disease assessment, with confirmed CR or PR.
Posted
Median
95% Confidence Interval
Months
From baseline up to 28 ~ 35 days after end of treatment (maximum of 6 months).
ID
Title
Description
OG000
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin [MVAC]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Secondary
Part 2: Progression Free Survival Based on Investigator Assessment (RECIST, v1.1)
Progression Free Survival (PFS) was defined as the time from initiation of PF-06939999 therapy to first documentation of tumor progression or to death due to any cause, whichever occurred first.
The analysis population included all participants in Part 2 who received at least one dose of study treatment and had baseline disease assessment or measurable disease at baseline, if applicable and at least one post baseline disease assessment.
Posted
Median
95% Confidence Interval
Months
From baseline up to 28 ~ 35 days after end of treatment (maximum of 6 months).
ID
Title
Description
OG000
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin [MVAC]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Secondary
Part 2: Time to Progression Based on Investigator Assessment (RECIST, v1.1)
Time to Progression (TTP) was defined as the time from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to tumor progression. Disease progression is defined using RECIST v 1.1.
The analysis population included all participants in Part 2 who received at least one dose of study treatment and had baseline disease assessment or measurable disease at baseline, if applicable and at least one post baseline disease assessment.
Posted
Median
95% Confidence Interval
Months
From baseline up to 28 ~ 35 days after end of treatment (maximum of 6 months).
ID
Title
Description
OG000
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin [MVAC]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Secondary
Part 2: Overall Survival
Overall Survival (OS) was defined as the time from the start date (first dose) of study treatment to the date of death due to any cause.
The analysis set included all participants in Part 2 who received at least 1 dose of study treatment.
Posted
Median
95% Confidence Interval
Months
From baseline up to maximum follow up (15 months).
ID
Title
Description
OG000
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin [MVAC]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG002
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
Secondary
Part 2: Probability of Survival at 6 Months and 1 Year of PF-06939999 Monotherapy
The probability of survival at select times was estimated using the Kaplan Meier method. Although an endpoint of Overall Survival at 2 years of study treatment was defined in the protocol, no data were collected/analyzed for this endpoint due to maximum follow up not reaching 2 year post study treatment.
The analysis set included all participants in Part 2 who received at least 1 dose of study treatment.
Posted
Number
95% Confidence Interval
probability of survival
From baseline up to maximum follow up (15 months).
ID
Title
Description
OG000
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG001
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin [MVAC]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Time Frame
Baseline up to a minimum of 28 days after last dose of study treatment (part 1 maximum of 13 months, part 2 maximum of 15 months)
Description
The same event may appear as both an AE and a 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
Part 1A: PF-06939999 0.5 mg QD
Part 1 is dose escalation part. Participants received PF-06939999 0.5 mg QD in 28-day cycles up to 2 years or until disease progression.
0
1
0
1
1
1
EG001
Part 1A: PF-06939999 0.5 mg BID
Participants received PF-06939999 0.5 mg BID in 28-day cycles up to 2 years or until disease progression.
0
1
0
1
1
1
EG002
Part 1A: PF-06939999 1 mg BID
Participants received PF-06939999 1 mg BID in 28-day cycles up to 2 years or until disease progression.
0
2
0
2
2
2
EG003
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
0
3
1
3
3
3
EG004
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
0
3
0
3
3
3
EG005
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
2
4
3
4
4
4
EG006
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
1
3
1
3
3
3
EG007
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
0
6
2
6
6
6
EG008
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
1
5
2
5
5
5
EG009
Part 2A: [2L+ Non-small Cell Lung Cancer (NSCLC)] PF-06939999 6mg QD
Part 2 is dose expansion part. Participants with NSCLC who had progressed after at least 1 line of checkpoint inhibitors and 1 line of platinum based chemotherapy (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
9
14
7
14
12
14
EG010
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin [MVAC]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
0
2
1
2
2
2
EG011
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
4
10
5
10
10
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected3 at risk
EG0040 affected3 at risk
EG0050 affected4 at risk
EG0060 affected3 at risk
EG0070 affected6 at risk
EG0080 affected5 at risk
EG0090 affected14 at risk
EG0101 affected2 at risk
EG0111 affected10 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Disease progression
General disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Fatigue
General disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Abscess neck
Infections and infestations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Sepsis
Infections and infestations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Urosepsis
Infections and infestations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Radiation necrosis
Injury, poisoning and procedural complications
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Syncope
Nervous system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Arterial rupture
Vascular disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Embolism
Vascular disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Hypertension
Vascular disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Hypotension
Vascular disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 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 v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected2 at risk
EG0031 affected3 at risk
EG0042 affected3 at risk
EG0052 affected4 at risk
EG0061 affected3 at risk
EG0073 affected6 at risk
EG0083 affected5 at risk
EG0094 affected14 at risk
EG0101 affected2 at risk
EG0115 affected10 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected2 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Cataract
Eye disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Scleral oedema
Eye disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected2 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected2 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected2 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Glossitis
Gastrointestinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Pancreatic failure
Gastrointestinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected2 at risk
EG003
Chest discomfort
General disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Chest pain
General disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Chills
General disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Fatigue
General disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected2 at risk
EG003
Influenza like illness
General disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Malaise
General disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Mucosal inflammation
General disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected2 at risk
EG003
Oedema peripheral
General disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Pain
General disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Pyrexia
General disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Cystitis
Infections and infestations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Ear infection
Infections and infestations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Infection
Infections and infestations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Influenza
Infections and infestations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Skin candida
Infections and infestations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Animal scratch
Injury, poisoning and procedural complications
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Tendon injury
Injury, poisoning and procedural complications
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Amylase increased
Investigations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Blood creatinine increased
Investigations
MedDRA v25.0
Non-systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Blood glucose decreased
Investigations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Lipase increased
Investigations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Platelet count decreased
Investigations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Weight decreased
Investigations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Weight increased
Investigations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
White blood cell count decreased
Investigations
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA v25.0
Non-systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0021 affected2 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Coccydynia
Musculoskeletal and connective tissue disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected2 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected2 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected2 at risk
EG003
Headache
Nervous system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Migraine
Nervous system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Presyncope
Nervous system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Somnolence
Nervous system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Syncope
Nervous system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Tremor
Nervous system disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Device malfunction
Product Issues
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Depression
Psychiatric disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected2 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected2 at risk
EG003
Irritability
Psychiatric disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected2 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Nephropathy
Renal and urinary disorders
MedDRA v25.0
Non-systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0001 affected1 at risk
EG0011 affected1 at risk
EG0020 affected2 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Pharyngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected2 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected2 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Hypertension
Vascular disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Hypotension
Vascular disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected2 at risk
EG003
Orthostatic hypertension
Vascular disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA v25.0
Non-systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG003
The study was terminated based on a strategic decision. This decision was not due to any safety concerns or requests from any regulatory authorities.
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.
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG008
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
2
OG0043
OG0052
OG0063
OG0076
OG0084
0
OG0040
OG0052
OG0061
OG0071
OG0080
OG002
Part 1A: PF-06939999 1 mg BID
Participants received PF-06939999 1 mg BID in 28-day cycles up to 2 years or until disease progression.
OG003
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
OG004
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
OG005
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
OG006
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
OG007
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG008
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0022
OG0033
OG0043
OG0054
OG0063
OG0076
OG0085
Title
Denominators
Categories
All-Causality TEAEs
Title
Measurements
OG0001
OG0011
OG0022
OG0033
OG0043
OG0054
OG0063
OG0076
OG0085
All-Causality SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
Maximum Grade 3 or 4 All-Causality AEs
Title
Measurements
OG0000
OG0010
OG0021
OG003
Maximum Grade 5 All-Causality AEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
All-causality TEAEs Leading to Discontinuation From Study
Title
Measurements
OG0000
OG0010
OG0020
OG003
Treatment-related TEAEs
Title
Measurements
OG0001
OG0011
OG0021
OG003
Treatment-related SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
Maximum Grade 3 or 4 Treatment-related AEs
Title
Measurements
OG0000
OG0010
OG0021
OG003
Maximum Grade 5 Treatment-related AEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
Treatment-related TEAEs leading to discontinuation form study
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
Part 1A: PF-06939999 1 mg BID
Participants received PF-06939999 1 mg BID in 28-day cycles up to 2 years or until disease progression.
OG003
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
OG004
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
OG005
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
OG006
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
OG007
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG008
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0022
OG0033
OG0043
OG0054
OG0063
OG0076
OG0085
Title
Denominators
Categories
Activated Partial Thromboplastin Time Prolonged (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0032
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0076
ParticipantsOG0084
Title
Measurements
OG0000
OG0010
OG0020
OG003
Anemia (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Hemoglobin Increased (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Leukocytosis (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
Lymphocyte Count Decreased (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Lymphocyte Count Decreased (Grade 4)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Lymphocyte Count Increased (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Neutrophil Count Decreased (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Neutrophil Count Decreased (Grade 4)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Platelet Count Decreased (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Platelet Count Decreased (Grade 4)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
White Blood Cell Decreased (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
White Blood Cell Decreased (Grade 4)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
Alanine Aminotransferase Increased (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Alanine Aminotransferase Increased (Grade 4)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Alkaline Phosphatase Increased (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Alkaline Phosphatase Increased (Grade 4)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Aspartate Aminotransferase Increased (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Aspartate Aminotransferase Increased (Grade 4)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Blood Bilirubin Increased (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Blood Bilirubin Increased (Grade 4)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Creatinine Increased (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Creatinine Increased (Grade 4)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Hypercalcemia (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Hypercalcemia (Grade 4)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Hyperkalemia (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Hyperkalemia (Grade 4)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Hypermagnesemia (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Hypermagnesemia (Grade 4)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Hypernatremia (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Hypernatremia (Grade 4)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Hypoalbuminemia (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Hypocalcemia (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Hypocalcemia (Grade 4)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Hypoglycemia (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Hypoglycemia (Grade 4)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Hypokalemia (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Hypokalemia (Grade 4)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Hypomagnesemia (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Hypomagnesemia (Grade 4)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Hyponatremia (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Hyponatremia (Grade 4)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Lipase Increased (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Lipase Increased (Grade 4)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Serum Amylase Increased (Grade 3)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Serum Amylase Increased (Grade 4)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0033
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin [MVAC]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG002
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG00014
OG0012
OG00210
Title
Denominators
Categories
All-Causality TEAEs
Title
Measurements
OG00014
OG0012
OG00210
All-Causality SAEs
Title
Measurements
OG0007
OG0011
OG0025
Maximum Grade 3 or 4 All-Causality AEs
Title
Measurements
OG00011
OG0012
OG0025
Maximum Grade 5 All-Causality AEs
Title
Measurements
OG0003
OG0010
OG0022
All-causality TEAEs Leading to Discontinuation From Study
Title
Measurements
OG0003
OG0010
OG0022
Treatment-related TEAEs
Title
Measurements
OG00010
OG0012
OG0029
Treatment related SAEs
Title
Measurements
OG0001
OG0011
OG0021
Maximum Grade 3 or 4 Treatment-related AEs
Title
Measurements
OG0005
OG0012
OG0024
Maximum Grade 5 Treatment-related AEs
Title
Measurements
OG0000
OG0010
OG0020
Treatment-related TEAEs leading to discontinuation form study
Title
Measurements
OG0000
OG0010
OG0020
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin [MVAC]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG002
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG00014
OG0012
OG00210
Title
Denominators
Categories
Activated Partial Thromboplastin Time Prolonged (Grade 3)
ParticipantsOG00011
ParticipantsOG0012
ParticipantsOG0028
Title
Measurements
OG0001
OG0010
OG0021
Anemia (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Hemoglobin Increased (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Leukocytosis (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Lymphocyte Count Decreased (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Lymphocyte Count Decreased (Grade 4)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Lymphocyte Count Increased (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Neutrophil Count Decreased (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Neutrophil Count Decreased (Grade 4)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Platelet Count Decreased (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Platelet Count Decreased (Grade 4)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
White Blood Cell Decreased (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
White Blood Cell Decreased (Grade 4)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Alanine Aminotransferase Increased (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Alanine Aminotransferase Increased (Grade 4)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Alkaline Phosphatase Increased (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Alkaline Phosphatase Increased (Grade 4)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Aspartate Aminotransferase Increased (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Aspartate Aminotransferase Increased (Grade 4)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Blood Bilirubin Increased (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Blood Bilirubin Increased (Grade 4)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Creatinine Increased (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Creatinine Increased (Grade 4)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Hypercalcemia (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Hypercalcemia (Grade 4)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Hyperkalemia (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Hyperkalemia (Grade 4)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Hypermagnesemia (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Hypermagnesemia (Grade 4)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Hypernatremia (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Hypernatremia (Grade 4)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Hypoalbuminemia (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Hypocalcemia (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Hypocalcemia (Grade 4)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Hypoglycemia (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Hypoglycemia (Grade 4)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Hypokalemia (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Hypokalemia (Grade 4)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Hypomagnesemia (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Hypomagnesemia (Grade 4)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Hyponatremia (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Hyponatremia (Grade 4)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Lipase Increased (Grade 3)
ParticipantsOG00011
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Lipase Increased (Grade 4)
ParticipantsOG00011
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Serum Amylase Increased (Grade 3)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
Serum Amylase Increased (Grade 4)
ParticipantsOG00013
ParticipantsOG0012
ParticipantsOG00210
Title
Measurements
OG000
OG001
Part 2B: (2L+ Urothelial Carcinoma) PF-06939999 6mg QD
Participants with urothelial carcinoma who had progressed after at least 1 line of standard of care systemic chemotherapy (cisplatin/carboplatin+ Gemcitabine; or methotrexate/vinblastine sulfate/doxorubicin hydrochloride/cisplatin [MVAC]) and checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG002
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG00011
OG0012
OG0028
Title
Denominators
Categories
Title
Measurements
Complete response (CR)
OG0000
OG0010
OG0020
Partial response (PR)
OG0001
OG0010
OG0020
Stable disease (SD)
OG0004
OG0012
OG0024
Non-CR/Non-PD
OG0000
OG0010
OG0020
Progressive disease (PD)
OG0004
OG0010
OG0024
Not evaluable (NE)
OG0002
OG0010
OG0020
OG003
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
OG004
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
OG005
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
OG006
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
OG007
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG008
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0022
OG0033
OG0043
OG0054
OG0063
OG0076
OG0085
Title
Denominators
Categories
Title
Measurements
OG000NA± NAGeometric mean and geometric coefficient of variation (CV) are not applicable due to n\<3.
OG001NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG002NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG0036.295± 13
OG00426.33± 70
OG00526.64± 63
OG00652.96± 85
OG00728.56± 72
OG00821.63± 82
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
OG004
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
OG005
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
OG006
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
OG007
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG008
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0022
OG0033
OG0043
OG0054
OG0063
OG0076
OG0085
Title
Denominators
Categories
Title
Measurements
OG0000.9(0.9 to 0.9)
OG0012.0(2.0 to 2.0)
OG0022.1(2.1 to 2.1)
OG0031.0(0.5 to 2.1)
OG0041.0(0.5 to 3.7)
OG0051.5(0.5 to 4.0)
OG0062.0(1.0 to 2.1)
OG0071.5(0.7 to 2.2)
OG0080.9(0.5 to 4.3)
OG003
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
OG004
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
OG005
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
OG006
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
OG007
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG008
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG0000
OG0010
OG0022
OG0033
OG0043
OG0054
OG0062
OG0074
OG0084
Title
Denominators
Categories
Title
Measurements
OG002NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG00320.52± 15
OG00493.77± 61
OG00588.94± 51
OG006NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG007256.7± 75
OG008136.4± 94
OG003
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
OG004
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
OG005
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
OG006
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
OG007
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG008
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0022
OG0032
OG0043
OG0051
OG0062
OG0076
OG0083
Title
Denominators
Categories
Title
Measurements
OG000NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG001NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG002NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG003NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG00459.78± 37
OG005NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG006NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG00759.32± 26
OG00829.39± 99
OG003
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
OG004
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
OG005
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
OG006
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
OG007
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG008
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0022
OG0032
OG0043
OG0051
OG0062
OG0076
OG0083
Title
Denominators
Categories
Title
Measurements
OG0000.5(0.5 to 0.5)
OG0015.6(5.6 to 5.6)
OG0020.75(0.5 to 1.0)
OG0031.6(1.0 to 2.2)
OG0040.5(0.5 to 1.9)
OG0051.0(1.0 to 1.0)
OG0061.5(1.0 to 2.0)
OG0071.0(0.5 to 2.2)
OG0081.9(0.5 to 2.1)
OG003
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
OG004
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
OG005
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
OG006
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
OG007
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG008
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0022
OG0032
OG0043
OG0051
OG0062
OG0076
OG0083
Title
Denominators
Categories
Title
Measurements
OG000NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG001NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG002NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG003NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG004437.4± 31
OG005NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG006NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG007718.3± 38
OG008360.6± 98
OG003
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
OG004
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
OG005
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
OG006
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
OG007
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG008
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0022
OG0032
OG0043
OG0051
OG0062
OG0076
OG0083
Title
Denominators
Categories
Title
Measurements
OG000NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG001NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG002NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG003NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG0049.163± 31
OG005NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG006NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG0078.358± 38
OG00811.09± 98
Participants received PF-06939999 1 mg BID in 28-day cycles up to 2 years or until disease progression.
OG003
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
OG004
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
OG005
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
OG006
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
OG007
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG008
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG0000
OG0010
OG0022
OG0032
OG0042
OG0051
OG0061
OG0074
OG0083
Title
Denominators
Categories
Title
Measurements
OG002NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG003NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG004NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG005NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG006NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG0073.262± 52
OG0082.526± 20
OG002
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG00013
OG0012
OG00210
Title
Denominators
Categories
Title
Measurements
OG00038.60± 93
OG001NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG00230.89± 50
OG002
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG00013
OG0012
OG00210
Title
Denominators
Categories
Title
Measurements
OG0000.9(0.5 to 2.2)
OG0011.25(0.5 to 2.0)
OG0021.0(0.9 to 2.0)
OG002
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG0009
OG0012
OG0027
Title
Denominators
Categories
Title
Measurements
OG00081.27± 57
OG001NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG00250.22± 40
OG002
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG0009
OG0012
OG0027
Title
Denominators
Categories
Title
Measurements
OG0001.1(0.5 to 4.0)
OG0012.05(2.0 to 2.1)
OG0022.1(1.0 to 4.0)
OG002
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG0009
OG0012
OG0027
Title
Denominators
Categories
Title
Measurements
OG00021.55± 93
OG001NA± NAGeometric mean and geometric CV are not applicable due to n\<3.
OG00217.33± 61
Counts
Participants
OG0000
Title
Denominators
Categories
Cmax with food
Cmax without food
Counts
Participants
OG0000
Title
Denominators
Categories
Tmax with food
Tmax without food
Participants
OG0000
Title
Denominators
Categories
AUClast with food
AUClast without food
OG003
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
OG004
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
OG005
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
OG006
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
OG007
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG008
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG0001
OG0011
OG0022
OG0032
OG0043
OG0052
OG0062
OG0076
OG0084
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 79.3)
OG0010(0.0 to 79.3)
OG0020(0.0 to 65.8)
OG00350.0(9.5 to 90.5)
OG00433.3(6.1 to 79.2)
OG0050(0.0 to 65.8)
OG0060(0.0 to 65.8)
OG0070(0.0 to 39.0)
OG0080(0.0 to 49.0)
Part 1A: PF-06939999 1 mg BID
Participants received PF-06939999 1 mg BID in 28-day cycles up to 2 years or until disease progression.
OG003
Part 1A: PF-06939999 2 mg BID
Participants received PF-06939999 2 mg BID in 28-day cycles up to 2 years or until disease progression.
OG004
Part 1A: PF-06939999 4 mg BID
Participants received PF-06939999 4 mg BID in 28-day cycles up to 2 years or until disease progression.
OG005
Part 1A: PF-06939999 6 mg BID
Participants received PF-06939999 6 mg BID in 28-day cycles up to 2 years or until disease progression.
OG006
Part 1A: PF-06939999 8 mg QD
Participants received PF-06939999 8 mg QD in 28-day cycles up to 2 years or until disease progression.
OG007
Part 1A: PF-06939999 6 mg QD
Participants received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
OG008
Part 1A: PF-06939999 4 mg QD
Participants received PF-06939999 4 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0031
OG0041
OG0050
OG0060
OG0070
OG0080
Title
Denominators
Categories
Title
Measurements
OG0034.3(NA to NA)95% Confidence Interval (CI) is not applicable due to n = 1.
OG0044.7(NA to NA)95% CI is not applicable due to n = 1.
OG002
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG0001
OG0010
OG0020
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and 95% CI are not applicable due to insufficient number of participants with events.
OG002
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG00011
OG0012
OG0028
Title
Denominators
Categories
Title
Measurements
OG0003.4(1.1 to NA)The upper limit of 95% CI is not applicable due to insufficient number of participants with events.
OG0015.5(NA to NA)95% CI is not applicable due to insufficient number of participants with events.
OG0021.9(1.6 to 5.6)
OG002
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG00011
OG0012
OG0028
Title
Denominators
Categories
Title
Measurements
OG0003.4(1.1 to NA)The upper limit of 95% CI is not applicable due to insufficient number of participants with events.
OG0015.5(NA to NA)95% CI is not applicable due to insufficient number of participants with events.
OG0021.9(1.6 to 5.6)
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG00014
OG0012
OG00210
Title
Denominators
Categories
Title
Measurements
OG0006.0(1.0 to NA)The upper limit of 95% CI is not applicable due to insufficient number of participants with events.
OG001NA(NA to NA)Median and 95% CI are not applicable due to insufficient number of participants with events.
OG00214.6(0.8 to NA)The upper limit of 95% CI is not applicable due to insufficient number of participants with events.
OG002
Part 2C: [2L+ Head and Neck Squamous Cell Carcinoma (HNSCC)] PF-06939999 6mg QD
Participants with HNSCC who had progressed after at least 1 line of standard of care systemic chemotherapy and 1 line of checkpoint inhibitor (2L+) received PF-06939999 6 mg QD in 28-day cycles up to 2 years or until disease progression.
Units
Counts
Participants
OG00014
OG0012
OG00210
Title
Denominators
Categories
6 Months
Title
Measurements
OG0000.550(0.258 to 0.768)
OG0011.000(1.000 to 1.000)
OG0020.778(0.365 to 0.939)
1 Year
Title
Measurements
OG0000.283(0.073 to 0.543)
OG001NA(NA to NA)Probability of survival and 95% CI are not applicable due to insufficient number of participants with events.