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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002704-84 | EudraCT Number |
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The study was prematurely discontinued due to a business-related decision on 09-FEB-2016. The decision to terminate the trial was based on the overall results.
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To assess the safety and tolerability at increasing dose levels of PF-06664178 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-06664178 | Experimental | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06664178 | Drug | Part 1 - PF-06664178 will be administered intravenously every 21 days in cohorts of 2 or more patients starting at a dose of 0.15 mg/kg. Increases in dose will continue until MTD is determined. |
| Measure | Description | Time Frame |
|---|---|---|
| First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD) | Number of participants that experienced dose limiting toxicities(DLTs) at given dose level. | Day 1 up to Day 21 |
| Number of Patients With All-Causality Treatment-Emergent Adverse Events(TEAEs) [Part 2 & 3] | An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug. | Day 1 up to Day 21 |
| Number of Participants With Laboratory Abnormalities [Part 2 & 3] | Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology( hemoglobin, platelets, white blood cell count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils), chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate), coagulation (prothrombin time or International normalized ratio, partial thromboplastin time), Urinalysis (urine protein, urine blood) and pregnancy test. | On Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs ) [Part 1] | An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug. |
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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 |
|---|---|---|---|---|---|---|
| Keck Hospital of USC | Los Angeles | California | 90033 | United States | ||
| LAC&USC Medical Center |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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A total of 38 patients were screened, among which 31 were assigned to study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-06664178 0.15 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. |
| FG001 | PF-06664178 0.30 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| FG002 | PF-06664178 0.60 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| FG003 | PF-06664178 1.20 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| FG004 | PF-06664178 2.40 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| FG005 | PF-06664178 3.60 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| FG006 | PF-06664178 4.20 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| FG007 | PF-06664178 4.80 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1: Dose Escalation |
|
| ||||||||||||||||||
| Part 2: Maximum Tolerated Dose |
| |||||||||||||||||||
| Part 3: Expansion |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-06664178 0.15 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD) | Number of participants that experienced dose limiting toxicities(DLTs) at given dose level. | All enrolled participants who started treatment. One of participants that experienced DLTs in PF-06664178 4.80mg/kg group was a late DLT that occurred at the beginning of Cycle 2 and was classified as a late DLT. | Posted | Number | participants | Day 1 up to Day 21 |
|
From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
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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-06664178 0.15 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
The study was terminated prematurely for business reasons
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D010051 | Ovarian Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002283 | Carcinoma, Bronchogenic |
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| PF-06664178 | Drug | Part 2 - patients with select tumor types (Non Small Cell Lung Cancer ovarian cancer, and breast cancer ) will be treated at the MTD selected in Part 1. |
|
| From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(At least 28 days and no more than 35 days after discontinuation of treatment) |
| Number of Participants With Laboratory Abnormalities[Part 1] | Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology( hemoglobin, platelets, white blood cell count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils), chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate), coagulation (prothrombin time or International normalized ratio, partial thromboplastin time), Urinalysis (urine protein, urine blood) and pregnancy test. | Screening; on Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued) |
| Overall Incidence of Anti-PF-06664178-Antibodies[Part 1] | Number of participants with the presence of anti-PF-06664178 antibodies | Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment |
| Overall Incidence of Anti-PF-06664178-Antibodies [Part 2 & 3] | Number of participants with the presence of anti-PF-06664178 antibodies | Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment |
| Overall Number of Participants With Objective Tumor Response[Part 1] | Objective tumor response, was assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 by calculating the Overall Response Rate, and Prolonged Stable Disease. The criterion is defined as: Objective Progression(PD):20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5mm; Stable (SD): All target lesions must be assessed. Stable can follow PR only in the rare case that the sum increases by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds; symptomatic deterioration(Sym):Participants with a global deterioration of health status requiring discontinuation of treatment without objective evidence of disease progression at that time; Indeterminate (In):Progression has not been determined and one, or more non-target sites were not assessed, or assessment methods were inconsistent with those used at baseline. | Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months |
| Overall Number of Participants With Objective Tumor Response [Part 2 & 3] | Objective tumor response, as assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 by calculating the Overall Response Rate (ORR), and Prolonged Stable Disease (SD).No Progression Free Survival (PFS) was completed. The criterion is as follow: Objective Progression(PD), Stable (SD), symptomatic deterioration(Sym), and Indeterminate (In) | Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months |
| Maximum Observed Plasma Concentration (Cmax) for PF-06664178 [Part 1 ,2 & 3] | Cmax of PF-06664178 was observed directly from data | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
| Maximum Observed Plasma Concentration (Cmax) for Total Antibody (PF-06479118) [Part 1 ,2 & 3] | Cmax of total antibody PF-06479118 was observed directly from data | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
| Maximum Observed Plasma Concentration (Cmax) for Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] | Cmax of unconjugated payload PF-06380101 was observed directly from data | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
| Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of PF-06664178 [Part 1 ,2 & 3] | AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
| Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of Total Antibody(PF-06479118) [Part 1 ,2 & 3] | AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval. | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
| Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of Unconjugated Payload(PF-06380101) [Part 1 ,2 & 3] | AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval. | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
| Systemic Clearance (CL) of PF-06664178 [Part 1 ,2 & 3] | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
| Systemic Clearance (CL) of Total Antibody (PF-06479118) [Part 1 ,2 & 3] | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
| Systemic Clearance (CL) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
| Volume of Distribution (Vss) of PF-06664178 [Part 1 ,2 & 3] | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
| Volume of Distribution (Vss) of Total Antibody (PF-06479118) [Part 1 ,2 & 3] | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
| Volume of Distribution (Vss) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
| Terminal Elimination Half-Life (t1/2) of PF-06664178 [Part 1 ,2 & 3] | Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
| Terminal Elimination Half-Life (t1/2) of Total Antibody (PF-06479118)[Part 1 ,2 & 3] | Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
| Terminal Elimination Half-Life (t1/2) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] | Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
| Trop-2 Expression Levels on Archived Tissue [Part 2 & 3] | Number of participents meeting the following criterion for Trop-2 expression assessment : low expression, medium expression and high expression | Day 1 |
| Accumulation Ratio (Rac) of PF-06664178 [Part 1 ,2 & 3] | Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval. | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
| Accumulation Ratio (Rac) of Total Antibody (PF-06479118) [Part 1 ,2 & 3] | Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval. | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
| Accumulation Ratio (Rac) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] | Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval. | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
| Los Angeles |
| California |
| 90033 |
| United States |
| USC/Norris Comprehensive Cancer Center / Investigational Drug Services | Los Angeles | California | 90033 | United States |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | United States |
| University of Colorado Denver CTO (CTRC) | Aurora | Colorado | 80045 | United States |
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Swedish Medical Center | Seattle | Washington | 98104 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Other |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | PF-06664178 0.30 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| BG002 | PF-06664178 0.60 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| BG003 | PF-06664178 1.20 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| BG004 | PF-06664178 2.40 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| BG005 | PF-06664178 3.60 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| BG006 | PF-06664178 4.20 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| BG007 | PF-06664178 4.80 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | PF-06664178 0.30 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| OG002 | PF-06664178 0.60 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| OG003 | PF-06664178 1.20 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| OG004 | PF-06664178 2.40 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| OG005 | PF-06664178 3.60 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| OG006 | PF-06664178 4.20 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
| OG007 | PF-06664178 4.80 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. |
|
|
| Primary | Number of Patients With All-Causality Treatment-Emergent Adverse Events(TEAEs) [Part 2 & 3] | An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug. | No participant was analyzed due to study termination | Posted | Day 1 up to Day 21 |
|
|
| Primary | Number of Participants With Laboratory Abnormalities [Part 2 & 3] | Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology( hemoglobin, platelets, white blood cell count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils), chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate), coagulation (prothrombin time or International normalized ratio, partial thromboplastin time), Urinalysis (urine protein, urine blood) and pregnancy test. | No participant was analyzed due to study termination | Posted | On Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued) |
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| Secondary | Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs ) [Part 1] | An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug. | All enrolled participants who started treatment | Posted | Number | participants | From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(At least 28 days and no more than 35 days after discontinuation of treatment) |
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| Secondary | Number of Participants With Laboratory Abnormalities[Part 1] | Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology( hemoglobin, platelets, white blood cell count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils), chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate), coagulation (prothrombin time or International normalized ratio, partial thromboplastin time), Urinalysis (urine protein, urine blood) and pregnancy test. | All enrolled participants who started treatment. | Posted | Number | participants | Screening; on Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued) |
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| Secondary | Overall Incidence of Anti-PF-06664178-Antibodies[Part 1] | Number of participants with the presence of anti-PF-06664178 antibodies | All enrolled participants who started treatment | Posted | Number | participants | Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment |
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| Secondary | Overall Incidence of Anti-PF-06664178-Antibodies [Part 2 & 3] | Number of participants with the presence of anti-PF-06664178 antibodies | No participant was analyzed due to study termination | Posted | Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment |
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| Secondary | Overall Number of Participants With Objective Tumor Response[Part 1] | Objective tumor response, was assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 by calculating the Overall Response Rate, and Prolonged Stable Disease. The criterion is defined as: Objective Progression(PD):20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5mm; Stable (SD): All target lesions must be assessed. Stable can follow PR only in the rare case that the sum increases by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds; symptomatic deterioration(Sym):Participants with a global deterioration of health status requiring discontinuation of treatment without objective evidence of disease progression at that time; Indeterminate (In):Progression has not been determined and one, or more non-target sites were not assessed, or assessment methods were inconsistent with those used at baseline. | Of all enrolled 31 patients who were treated, 1 participant from the 0.60mg/kg cohort and 1 participant from the 4.20mg/kg cohort did not have post-dose tumor evaluations for they were discontinued form study prior to having disease assessment . | Posted | Number | participants | Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months |
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| Secondary | Overall Number of Participants With Objective Tumor Response [Part 2 & 3] | Objective tumor response, as assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 by calculating the Overall Response Rate (ORR), and Prolonged Stable Disease (SD).No Progression Free Survival (PFS) was completed. The criterion is as follow: Objective Progression(PD), Stable (SD), symptomatic deterioration(Sym), and Indeterminate (In) | No participant was analyzed due to study termination | Posted | Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) for PF-06664178 [Part 1 ,2 & 3] | Cmax of PF-06664178 was observed directly from data | Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination | Posted | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) for Total Antibody (PF-06479118) [Part 1 ,2 & 3] | Cmax of total antibody PF-06479118 was observed directly from data | Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination | Posted | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) for Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] | Cmax of unconjugated payload PF-06380101 was observed directly from data | Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination | Posted | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
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| Secondary | Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of PF-06664178 [Part 1 ,2 & 3] | AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval | Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination | Posted | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
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| Secondary | Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of Total Antibody(PF-06479118) [Part 1 ,2 & 3] | AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval. | Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination | Posted | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
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| Secondary | Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of Unconjugated Payload(PF-06380101) [Part 1 ,2 & 3] | AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval. | Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination | Posted | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
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| Secondary | Systemic Clearance (CL) of PF-06664178 [Part 1 ,2 & 3] | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination | Posted | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
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|
| Secondary | Systemic Clearance (CL) of Total Antibody (PF-06479118) [Part 1 ,2 & 3] | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination | Posted | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
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|
| Secondary | Systemic Clearance (CL) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination | Posted | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
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| Secondary | Volume of Distribution (Vss) of PF-06664178 [Part 1 ,2 & 3] | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. | Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination | Posted | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
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| Secondary | Volume of Distribution (Vss) of Total Antibody (PF-06479118) [Part 1 ,2 & 3] | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. | Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination | Posted | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
|
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| Secondary | Volume of Distribution (Vss) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. | Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination | Posted | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
|
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| Secondary | Terminal Elimination Half-Life (t1/2) of PF-06664178 [Part 1 ,2 & 3] | Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half | Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination | Posted | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
|
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| Secondary | Terminal Elimination Half-Life (t1/2) of Total Antibody (PF-06479118)[Part 1 ,2 & 3] | Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half | Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination | Posted | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
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|
| Secondary | Terminal Elimination Half-Life (t1/2) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] | Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half | Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination | Posted | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
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| Secondary | Trop-2 Expression Levels on Archived Tissue [Part 2 & 3] | Number of participents meeting the following criterion for Trop-2 expression assessment : low expression, medium expression and high expression | No participant was analyzed due to study termination | Posted | Day 1 |
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| Secondary | Accumulation Ratio (Rac) of PF-06664178 [Part 1 ,2 & 3] | Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval. | Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination | Posted | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
|
|
| Secondary | Accumulation Ratio (Rac) of Total Antibody (PF-06479118) [Part 1 ,2 & 3] | Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval. | Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination | Posted | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
|
|
| Secondary | Accumulation Ratio (Rac) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] | Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval. | Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination | Posted | 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment |
|
|
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | PF-06664178 0.30 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | 1 | 2 | 2 | 2 |
| EG002 | PF-06664178 0.60 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | 2 | 4 | 4 | 4 |
| EG003 | PF-06664178 1.20 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | 0 | 4 | 4 | 4 |
| EG004 | PF-06664178 2.40 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | 1 | 4 | 4 | 4 |
| EG005 | PF-06664178 3.60 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | 3 | 6 | 6 | 6 |
| EG006 | PF-06664178 4.20 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | 1 | 1 | 1 | 1 |
| EG007 | PF-06664178 4.80 mg/kg | Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis. | 5 | 8 | 8 | 8 |
| EG008 | Total | Treatment Group Description TBD | 13 | 31 | 31 | 31 |
| Disease progression | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Lip blister | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Palatal disorder | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Tongue disorder | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Early satiety | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Face oedema | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Local swelling | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 19.1 | Non-systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 19.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Hallucination, auditory | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Scrotal erythema | Reproductive system and breast disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Facial wasting | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Red man syndrome | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Skin striae | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 19.1 | Non-systematic Assessment |
|
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.
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| PD |
|
| Sym |
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| In |
|