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The study was terminated due to a change in sponsor prioritization.
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To assess the safety and tolerability at increasing dose levels of PF-06650808 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06650808 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06650808 | Drug | Dose Escalation Phase [Part 1] - PF-06650808 will be administered at doses starting at 0.2 mg/kg. Increases in dose will continue until MTD is determined. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLT) (Part 1) | Severity of AEs (adverse events ) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs which were not considered related to disease progression occurring in the first cycle of treatment (21 days) were classified as DLTs: 1) Hematologic: Grade 4 neutropenia lasting >7 days; Febrile neutropenia; Grade>=3 neutropenia with infection; Any grade thrombocytopenia associated with clinically significant or life threatening bleeding; Grade 4 thrombocytopenia >=72 hours or platelets<=10,000/mm3 regardless of duration. 2) Non hematologic: Grade>=3 toxicities except those that had not been maximally treated; Delayed by more than 2 weeks in receiving the next scheduled cycle due to persisting toxicities not attributable to disease progression. 3) clinically important or persistent toxicities may have been considered a DLT following review by the Sponsor and the investigators. | Day 1 up to Day 21 |
| Percentage of Participants With Objective Response (Part 1 and Part 2) | Assessment of response was made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant achieved complete response (CR) if both target and non-target lesions achieved CR, no new lesions; achieved partial response (PR) if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits. The overall objective response was defined as confirmed CR and PR. | Day 1 and every 6 weeks until disease progression, unacceptable toxicity, or up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2) | AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ronald Reagan UCLA Medical Center, Drug Information Center | Los Angeles | California | 90095 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30887250 | Derived | Rosen LS, Wesolowski R, Baffa R, Liao KH, Hua SY, Gibson BL, Pirie-Shepherd S, Tolcher AW. A phase I, dose-escalation study of PF-06650808, an anti-Notch3 antibody-drug conjugate, in patients with breast cancer and other advanced solid tumors. Invest New Drugs. 2020 Feb;38(1):120-130. doi: 10.1007/s10637-019-00754-y. Epub 2019 Mar 18. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-06650808 0.2 mg/kg (Part 1) | PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| FG001 | PF-06650808 0.4 mg/kg (Part 1) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 7, 2014 | Jun 13, 2018 |
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| PF-06650808 | Drug | Dose Expansion Phase [Part 2] - Patients will be treated at the MTD or Recommended Phase 2 dose selected in Part 1. |
|
| 3 years |
| Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Hematology) (Part 1 and Part 2) | Hematology evaluation included hemoglobin, platelets, white blood cell, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils and absolute basophils. The participants who experienced laboratory test abnormalities were determined by investigators. | 3 years |
| Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2) | Chemistry evaluation included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, sodium, potassium, magnesium, chloride, calcium, total bilirubin, blood urea nitrogen (BUN) or urea, creatinine, uric acid, glucose (non-fasted), albumin, phosphorus, bicarbonate or carbon dioxide, total protein and lactate dehydrogenase. The participants who experienced laboratory test abnormalities were determined by investigators. | 3 years |
| Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Urinalysis) (Part 1 and Part 2) | Urinalysis included urine protein. Microscopic analyses were performed if dipstick was abnormal. The participants who experienced laboratory test abnormalities were determined by investigators. | 3 years |
| Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2) | Vital Signs tests included systolic and diastolic blood pressure (BP) and pulse rate of seated supine and standing . Vital signs categorical summarization criteria were 1), supine and standing BP: systolic (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from baseline, diastolic <50 mm Hg; 2), supine and standing pulse rate <40 or greater than (>) 120 beats per minute (bpm). | 3 years |
| Maximum Observed Serum Concentration (Cmax) (Part 1 and Part 2) | Maximum observed serum concentration (Cmax) of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were observed directly from data. PF-06650808 is comprised of an antibody (PF-06460005) and a cytotoxic agent (PF-06380101). | Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4 |
| Time to Reach Maximum Observed Serum Concentration (Tmax) (Part 1 and Part 2) | Tmax of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were observed directly from data as time of first occurrence. | Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4 |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) (Part 1 and Part 2) | Tau refers to the dosing interval, and it equals to 504 hours (3 weeks) of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were determined using linear/log trapezoidal method. | Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4 |
| Clearance (CL) (Part 1 and Part 2) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL was calculated as dose/AUCinf, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time. CL was only for PF-06650808 (ADC) and Cycle 1. | Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 |
| Volume of Distribution at Steady State (Vss) (Part 1 and Part 2) | Vss was calculated as dose/(AUCinf × kel), where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Vss was only for PF-06650808 (ADC) and Cycle 1. | Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 |
| Terminal Elimination Half-Life (t1/2) (Part 1 and Part 2) | Terminal elimination half-life was defined as the time measured for the serum concentration to decrease by one half, and calculated as loge(2)/kel. | Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4 |
| Number of Participants With the Presence of Anti-PF-06650808 Antibodies (Part 1 and Part 2) | Assays to assess for anti drug (anti PF-06650808) antibodies (ADA) were performed. Positive ADA: titer>=1.88. | 3 years |
| Progression Free Survival and Overall Survival (Part 2) | Progression Free Survival was defined as the time from Cycle 1 Day 1 (C1D1) to first documentation of disease progression or to death due to any cause, whichever occurs first. Overall survival was defined as the time from initial dose until death from any cause, and is measured in the intent to treat population. | 3 years |
| Ronald Reagan UCLA Medical Center |
| Los Angeles |
| California |
| 90095 |
| United States |
| UCLA Hematology/Oncology | Los Angeles | California | 90095 | United States |
| Westwood Bowyer Clinic | Los Angeles | California | 90095 | United States |
| Santa Monica - UCLA Medical Center & Orthopaedic Hospital | Santa Monica | California | 90404 | United States |
| UCLA Hematology/Oncology - Santa Monica | Santa Monica | California | 90404 | United States |
| The Ohio State University James Cancer Hospital | Columbus | Ohio | 43210 | United States |
| The OSU Investigational Drug Services | Columbus | Ohio | 43210 | United States |
| The OSU Stephanie Spielman Comprehensive Breast Center | Columbus | Ohio | 43212 | United States |
| The Ohio State University Martha Morehouse Medical Plaza | Columbus | Ohio | 43221 | United States |
| South Texas Accelerated Research Therapeutics, LLC (START) | San Antonio | Texas | 78229 | United States |
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| FG002 | PF-06650808 0.8 mg/kg (Part 1) | PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| FG003 | PF-06650808 1.6 mg/kg (Part 1) | PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| FG004 | PF-06650808 2.0 mg/kg (Part 1) | PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| FG005 | PF-06650808 2.4 mg/kg (Part 1) | PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| FG006 | PF-06650808 3.0 mg/kg (Part 1) | PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| FG007 | PF-06650808 3.6 mg/kg (Part 1) | PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| FG008 | PF-06650808 4.68 mg/kg (Part 1) | PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| FG009 | PF-06650808 2.4mg/kg (Part 2) | Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the maximum tolerated dose (MTD). The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Baseline analysis population included all participants who received at least 1 dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-06650808 0.2 mg/kg (Part 1) | PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| BG001 | PF-06650808 0.4 mg/kg (Part 1) | PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| BG002 | PF-06650808 0.8 mg/kg (Part 1) | PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| BG003 | PF-06650808 1.6 mg/kg (Part 1) | PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| BG004 | PF-06650808 2.0 mg/kg (Part 1) | PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| BG005 | PF-06650808 2.4 mg/kg (Part 1) | PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| BG006 | PF-06650808 3.0 mg/kg (Part 1) | PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| BG007 | PF-06650808 3.6 mg/kg (Part 1) | PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| BG008 | PF-06650808 4.68 mg/kg (Part 1) | PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| BG009 | PF-06650808 2.4 mg/kg (Part 2) | Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study. |
| BG010 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose-limiting Toxicities (DLT) (Part 1) | Severity of AEs (adverse events ) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs which were not considered related to disease progression occurring in the first cycle of treatment (21 days) were classified as DLTs: 1) Hematologic: Grade 4 neutropenia lasting >7 days; Febrile neutropenia; Grade>=3 neutropenia with infection; Any grade thrombocytopenia associated with clinically significant or life threatening bleeding; Grade 4 thrombocytopenia >=72 hours or platelets<=10,000/mm3 regardless of duration. 2) Non hematologic: Grade>=3 toxicities except those that had not been maximally treated; Delayed by more than 2 weeks in receiving the next scheduled cycle due to persisting toxicities not attributable to disease progression. 3) clinically important or persistent toxicities may have been considered a DLT following review by the Sponsor and the investigators. | The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. | Posted | Count of Participants | Participants | Day 1 up to Day 21 |
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| Primary | Percentage of Participants With Objective Response (Part 1 and Part 2) | Assessment of response was made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant achieved complete response (CR) if both target and non-target lesions achieved CR, no new lesions; achieved partial response (PR) if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits. The overall objective response was defined as confirmed CR and PR. | The analysis population included all participants who received at least 1 dose of study medication and had both baseline and at least 1 post-baseline tumor assessments. The study was prematurely terminated prior to the start of dose expansion phase (Part 2). | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 and every 6 weeks until disease progression, unacceptable toxicity, or up to 3 years |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2) | AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. | The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2). | Posted | Count of Participants | Participants | 3 years |
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| Secondary | Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Hematology) (Part 1 and Part 2) | Hematology evaluation included hemoglobin, platelets, white blood cell, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils and absolute basophils. The participants who experienced laboratory test abnormalities were determined by investigators. | The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2). | Posted | Count of Participants | Participants | 3 years |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2) | Chemistry evaluation included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, sodium, potassium, magnesium, chloride, calcium, total bilirubin, blood urea nitrogen (BUN) or urea, creatinine, uric acid, glucose (non-fasted), albumin, phosphorus, bicarbonate or carbon dioxide, total protein and lactate dehydrogenase. The participants who experienced laboratory test abnormalities were determined by investigators. | The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2). | Posted | Count of Participants | Participants | 3 years |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Urinalysis) (Part 1 and Part 2) | Urinalysis included urine protein. Microscopic analyses were performed if dipstick was abnormal. The participants who experienced laboratory test abnormalities were determined by investigators. | The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2). | Posted | Count of Participants | Participants | 3 years |
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| Secondary | Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2) | Vital Signs tests included systolic and diastolic blood pressure (BP) and pulse rate of seated supine and standing . Vital signs categorical summarization criteria were 1), supine and standing BP: systolic (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from baseline, diastolic <50 mm Hg; 2), supine and standing pulse rate <40 or greater than (>) 120 beats per minute (bpm). | The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2). | Posted | Count of Participants | Participants | 3 years |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Observed Serum Concentration (Cmax) (Part 1 and Part 2) | Maximum observed serum concentration (Cmax) of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were observed directly from data. PF-06650808 is comprised of an antibody (PF-06460005) and a cytotoxic agent (PF-06380101). | The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2). | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4 |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Reach Maximum Observed Serum Concentration (Tmax) (Part 1 and Part 2) | Tmax of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were observed directly from data as time of first occurrence. | The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2). | Posted | Median | Full Range | hr | Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4 |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) (Part 1 and Part 2) | Tau refers to the dosing interval, and it equals to 504 hours (3 weeks) of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were determined using linear/log trapezoidal method. | The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2). | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4 |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clearance (CL) (Part 1 and Part 2) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL was calculated as dose/AUCinf, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time. CL was only for PF-06650808 (ADC) and Cycle 1. | The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2). | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Volume of Distribution at Steady State (Vss) (Part 1 and Part 2) | Vss was calculated as dose/(AUCinf × kel), where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Vss was only for PF-06650808 (ADC) and Cycle 1. | The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2). | Posted | Geometric Mean | Geometric Coefficient of Variation | L | Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Terminal Elimination Half-Life (t1/2) (Part 1 and Part 2) | Terminal elimination half-life was defined as the time measured for the serum concentration to decrease by one half, and calculated as loge(2)/kel. | The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2). | Posted | Mean | Standard Deviation | hr | Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4 |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Presence of Anti-PF-06650808 Antibodies (Part 1 and Part 2) | Assays to assess for anti drug (anti PF-06650808) antibodies (ADA) were performed. Positive ADA: titer>=1.88. | The analysis population included all participants who received at least 1 dose of study medication and had at least 1 post-dose ADA measurements. The study was prematurely terminated prior to the start of dose expansion phase (Part 2). | Posted | Count of Participants | Participants | 3 years |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival and Overall Survival (Part 2) | Progression Free Survival was defined as the time from Cycle 1 Day 1 (C1D1) to first documentation of disease progression or to death due to any cause, whichever occurs first. Overall survival was defined as the time from initial dose until death from any cause, and is measured in the intent to treat population. | The study was prematurely terminated prior to the start of dose expansion phase (Part 2). | Posted | 3 years |
|
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-06650808 0.2 mg/kg | PF-06650808 0.2 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG001 | PF-06650808 0.4 mg/kg | PF-06650808 0.4 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG002 | PF-06650808 0.8 mg/kg | PF-06650808 0.8 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG003 | PF-06650808 1.6 mg/kg | PF-06650808 1.6 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG004 | PF-06650808 2.0 mg/kg | PF-06650808 2.0 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. | 1 | 7 | 1 | 7 | 7 | 7 |
| EG005 | PF-06650808 2.4 mg/kg | PF-06650808 2.4 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. | 1 | 11 | 3 | 11 | 11 | 11 |
| EG006 | PF-06650808 3.0 mg/kg | PF-06650808 3.0 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. | 0 | 6 | 3 | 6 | 6 | 6 |
| EG007 | PF-06650808 3.6 mg/kg | PF-06650808 3.6 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. | 0 | 6 | 3 | 6 | 6 | 6 |
| EG008 | PF-06650808 4.68 mg/kg | PF-06650808 4.68 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes. | 0 | 2 | 2 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Foreign body sensation in eyes | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rectal tenesmus | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Induration | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Blood parathyroid hormone increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| White blood cell count | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nystagmus | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Menopausal symptoms | Reproductive system and breast disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Systolic hypertension | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
The study was prematurely terminated as a business decision prior to the start of the dose expansion stage.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 17, 2014 | Jun 13, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000711077 | PF-06650808 |
Not provided
Not provided
Not provided
| Male |
|
| Black |
|
| Asian |
|
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG007 | PF-06650808 3.6 mg/kg (Part 1) | PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG008 | PF-06650808 4.68 mg/kg (Part 1) | PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| No |
|
| OG001 | PF-06650808 0.4 mg/kg (Part 1) | PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG002 | PF-06650808 0.8 mg/kg (Part 1) | PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG003 | PF-06650808 1.6 mg/kg (Part 1) | PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG004 | PF-06650808 2.0 mg/kg (Part 1) | PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG005 | PF-06650808 2.4 mg/kg (Part 1) | PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG006 | PF-06650808 3.0 mg/kg (Part 1) | PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG007 | PF-06650808 3.6 mg/kg (Part 1) | PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG008 | PF-06650808 4.68 mg/kg (Part 1) | PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG009 | PF-06650808 2.4 mg/kg (Part 2) | Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study. |
|
|
| PF-06650808 0.4 mg/kg (Part 1) |
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG002 | PF-06650808 0.8 mg/kg (Part 1) | PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG003 | PF-06650808 1.6 mg/kg (Part 1) | PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG004 | PF-06650808 2.0 mg/kg (Part 1) | PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG005 | PF-06650808 2.4 mg/kg (Part 1) | PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG006 | PF-06650808 3.0 mg/kg (Part 1) | PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG007 | PF-06650808 3.6 mg/kg (Part 1) | PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG008 | PF-06650808 4.68 mg/kg (Part 1) | PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG009 | PF-06650808 2.4 mg/kg (Part 2) | Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study. |
|
|
| OG003 | PF-06650808 1.6 mg/kg (Part 1) | PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG004 | PF-06650808 2.0 mg/kg (Part 1) | PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG005 | PF-06650808 2.4 mg/kg (Part 1) | PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG006 | PF-06650808 3.0 mg/kg (Part 1) | PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG007 | PF-06650808 3.6 mg/kg (Part 1) | PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG008 | PF-06650808 4.68 mg/kg (Part 1) | PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG009 | PF-06650808 2.4 mg/kg (Part 2) | Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study. |
|
|
| PF-06650808 0.8 mg/kg (Part 1) |
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG003 | PF-06650808 1.6 mg/kg (Part 1) | PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG004 | PF-06650808 2.0 mg/kg (Part 1) | PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG005 | PF-06650808 2.4 mg/kg (Part 1) | PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG006 | PF-06650808 3.0 mg/kg (Part 1) | PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG007 | PF-06650808 3.6 mg/kg (Part 1) | PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG008 | PF-06650808 4.68 mg/kg (Part 1) | PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG009 | PF-06650808 2.4 mg/kg (Part 2) | Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study. |
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| OG003 | PF-06650808 1.6 mg/kg (Part 1) | PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG004 | PF-06650808 2.0 mg/kg (Part 1) | PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG005 | PF-06650808 2.4 mg/kg (Part 1) | PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG006 | PF-06650808 3.0 mg/kg (Part 1) | PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG007 | PF-06650808 3.6 mg/kg (Part 1) | PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG008 | PF-06650808 4.68 mg/kg (Part 1) | PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG009 | PF-06650808 2.4 mg/kg (Part 2) | Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study. |
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| PF-06650808 0.8 mg/kg (Part 1) |
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG003 | PF-06650808 1.6 mg/kg (Part 1) | PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG004 | PF-06650808 2.0 mg/kg (Part 1) | PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG005 | PF-06650808 2.4 mg/kg (Part 1) | PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG006 | PF-06650808 3.0 mg/kg (Part 1) | PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG007 | PF-06650808 3.6 mg/kg (Part 1) | PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG008 | PF-06650808 4.68 mg/kg (Part 1) | PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG009 | PF-06650808 2.4 mg/kg (Part 2) | Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study. |
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|
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
| OG003 | PF-06650808 1.6 mg/kg (Part 1) | PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG004 | PF-06650808 2.0 mg/kg (Part 1) | PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG005 | PF-06650808 2.4 mg/kg (Part 1) | PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG006 | PF-06650808 3.0 mg/kg (Part 1) | PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG007 | PF-06650808 3.6 mg/kg (Part 1) | PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG008 | PF-06650808 4.68 mg/kg (Part 1) | PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG009 | PF-06650808 2.4 mg/kg (Part 2) | Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study. |
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|
| OG003 | PF-06650808 1.6 mg/kg (Part 1) | PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG004 | PF-06650808 2.0 mg/kg (Part 1) | PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG005 | PF-06650808 2.4 mg/kg (Part 1) | PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG006 | PF-06650808 3.0 mg/kg (Part 1) | PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG007 | PF-06650808 3.6 mg/kg (Part 1) | PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG008 | PF-06650808 4.68 mg/kg (Part 1) | PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG009 | PF-06650808 2.4 mg/kg (Part 2) | Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study. |
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|
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
| OG003 | PF-06650808 1.6 mg/kg (Part 1) | PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG004 | PF-06650808 2.0 mg/kg (Part 1) | PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG005 | PF-06650808 2.4 mg/kg (Part 1) | PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG006 | PF-06650808 3.0 mg/kg (Part 1) | PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG007 | PF-06650808 3.6 mg/kg (Part 1) | PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG008 | PF-06650808 4.68 mg/kg (Part 1) | PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG009 | PF-06650808 2.4 mg/kg (Part 2) | Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study. |
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|
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
| OG003 | PF-06650808 1.6 mg/kg (Part 1) | PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG004 | PF-06650808 2.0 mg/kg (Part 1) | PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG005 | PF-06650808 2.4 mg/kg (Part 1) | PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG006 | PF-06650808 3.0 mg/kg (Part 1) | PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG007 | PF-06650808 3.6 mg/kg (Part 1) | PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG008 | PF-06650808 4.68 mg/kg (Part 1) | PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG009 | PF-06650808 2.4 mg/kg (Part 2) | Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study. |
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|
| OG003 | PF-06650808 1.6 mg/kg (Part 1) | PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG004 | PF-06650808 2.0 mg/kg (Part 1) | PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG005 | PF-06650808 2.4 mg/kg (Part 1) | PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG006 | PF-06650808 3.0 mg/kg (Part 1) | PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG007 | PF-06650808 3.6 mg/kg (Part 1) | PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG008 | PF-06650808 4.68 mg/kg (Part 1) | PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG009 | PF-06650808 2.4 mg/kg (Part 2) | Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study. |
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|
| OG003 | PF-06650808 1.6 mg/kg (Part 1) | PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG004 | PF-06650808 2.0 mg/kg (Part 1) | PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG005 | PF-06650808 2.4 mg/kg (Part 1) | PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG006 | PF-06650808 3.0 mg/kg (Part 1) | PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG007 | PF-06650808 3.6 mg/kg (Part 1) | PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG008 | PF-06650808 4.68 mg/kg (Part 1) | PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG009 | PF-06650808 2.4 mg/kg (Part 2) | Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study. |
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|
| OG003 | PF-06650808 1.6 mg/kg (Part 1) | PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG004 | PF-06650808 2.0 mg/kg (Part 1) | PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG005 | PF-06650808 2.4 mg/kg (Part 1) | PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG006 | PF-06650808 3.0 mg/kg (Part 1) | PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG007 | PF-06650808 3.6 mg/kg (Part 1) | PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG008 | PF-06650808 4.68 mg/kg (Part 1) | PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred. |
| OG009 | PF-06650808 2.4 mg/kg (Part 2) | Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study. |
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