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A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02222922
Recruitment Status : Completed
First Posted : August 22, 2014
Results First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
To assess the safety and tolerability at increasing dose levels of PF-06647020 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: PF-06647020 Q3W Drug: fluconazole Drug: PF-06647020 Q2W Drug: PF-06647020 combined with Avelumab Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A FIRST-IN-HUMAN PHASE 1, DOSE ESCALATION, SAFETY AND PHARMACOKINETIC STUDY OF PF-06647020 IN ADULT PATIENTS WITH ADVANCED SOLID TUMORS
Actual Study Start Date : October 17, 2014
Actual Primary Completion Date : November 5, 2019
Actual Study Completion Date : November 5, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PF-06647020 Q3W
Investigational drug infused over 60 minutes once every 21 days.
Drug: PF-06647020 Q3W

Part 1: PF-06647020 will be administered intravenously every 21 days in cohorts of 2-4 patients starting at a dose of 0.20mg/kg. Increases in dose will continue until MTD is determined.

Part 2: Patients with triple negative breast cancer (pre-selected for PTK7 moderately high to high expression), non small cell lung cancer (pre-selected with moderate to high PTK7 expression) and ovarian cancer patients (unselected for PTK7 expression) will be treated at the MTD or Recommended Phase 2 Dose selected in Part 1.


Experimental: Drug-drug interaction (DDI)
PF-06647020 combined with fluconazole
Drug: fluconazole
combination drug used for drug-drug interaction sub-study

Experimental: PF-06647020 Q2W
Investigational drug infused over 60 minutes once every 14 days (28 day cycle)
Drug: PF-06647020 Q2W

Part 1: PF-06647020 will be administered intravenously every 14 days in cohorts of 2-4 patients starting at a dose of 2.1 mg/kg. Increases in dose will continue until MTD is determined.

Part 2: Patients with non-small cell lung cancer (pre-selected for PTK7 moderate to high expression and ovarian cancer patients (unselected for PTK7 expression) will be treated at the MTD or Recommended Phase 2 Dose selected in Part 1.


Experimental: PF-06647020 combined with Avelumab
PF-06647020 combined with Avelumab administered by infusion
Drug: PF-06647020 combined with Avelumab
Part 2: Patients with ovarian cancer (unselected for PTK7 expression) will be treated with PF-0664702 plus Avelumab.




Primary Outcome Measures :
  1. Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen [ Time Frame: First Cycle, Day 1 up to Day 21 ]
    A DLT was any of the following adverse events(AEs) in the first cycle of treatment (within 21 days of first dose or until participant received second infusion if there were treatment delays). (1)Hematologic: including Grade 4 neutropenia lasting >7 days; Febrile neutropenia; Grade >=3 neutropenic infection; Grade 4 anemia; Grade >=3 thrombocytopenia with clinically significant bleeding. (2) Hepatic, including Grade >=3 serum bilirubin, hepatic transaminase or alkaline phosphatase; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=3.0 x upper limit of normal (ULN) concurrent with elevation in bilirubin >=2.0 x ULN; (3) Grade >=3 non-hematologic, non-hepatic major organ toxicities; delayed by >2 weeks in receiving the next scheduled cycle due to persisting toxicities attributable to PF-06647020. A participant was on study for at least 21 days to be evaluable for DLT observation, and could be replaced if they terminated study participation earlier than 21 days.

  2. Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality) [ Time Frame: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months) ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.

  3. Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related) [ Time Frame: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months) ]
    A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.

  4. Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) [ Time Frame: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months) ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. All AEs were graded by the investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.

  5. Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen [ Time Frame: From baseline to end of treatment (approximately 32 months). ]
    Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameters: absolute neutrophils, lymphopenia, white blood cell, anemia, platelets.

  6. Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen [ Time Frame: From baseline to end of treatment (approximately 32 months). ]
    Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameters: hypokalemia, hypophosphatemia, aspartate aminotransferase, hyperglycemia, alkaline phosphatase, hyponatremia, alanine aminotransferase, hypoalbuminemia, total bilirubin, hypercalcemia, hypomagnesemia , creatinine, gamma glutamyl transferase, hypocalcemia.

  7. Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen [ Time Frame: From baseline to end of treatment (approximately 32 months). ]
    Participants who experienced urinalysis laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with urinalysis laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above.

  8. Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen [ Time Frame: From baseline to end of treatment (approximately 32 months). ]
    Participants who experienced coagulation laboratory test abnormalities were summarized according to worst toxicity grade observed for each coagulation laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with coagulation laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameter: partial thromboplastin time.

  9. Number of Participants With DLTs - Q2W Regimen [ Time Frame: First cycle, Day 1 up to Day 28 ]
    A DLT was any of the following AEs in the first cycle of treatment (within 28 days of first dose or until participant received second infusion if there were treatment delayed) in the single agent dose escalation. (1)Hematologic: including Grade 4 neutropenia lasting >7 days; Febrile neutropenia; Grade >=3 neutropenic infection; Grade 4 thrombocytopenia; treatment delay >14 days because of hematologic AE; (2) Hepatic: including Grade>=3 serum bilirubin, hepatic transaminase or alkaline phosphatase; ALT or AST>=3.0 x ULN concurrent with elevation in bilirubin>=2.0 x ULN; (3) Grade >=3 non-hematologic, non-hepatic major organ toxicities; delayed by >2 weeks in receiving the next scheduled cycle due to persisting toxicities attributable to PF-06647020. Grade >=3 headache lasting >48 hours in presence of supportive care. A participant was on study for at least 28 days to be evaluable for DLT observation, and could be replaced if they terminated study participation earlier than 28 days.

  10. Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality) [ Time Frame: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months) ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.

  11. Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related) [ Time Frame: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months) ]
    A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.

  12. Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) [ Time Frame: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months) ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. All AEs were graded by the investigator according to the NCI CTCAE version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.

  13. Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen [ Time Frame: From baseline to end of treatment (approximately 19 months). ]
    Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameters: absolute neutrophils, lymphopenia, white blood cell, anemia.

  14. Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen [ Time Frame: From baseline to end of treatment (approximately 19 months). ]
    Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameters: hypokalemia, hyponatremia, hypomagnesemia, hypoalbuminemia, hypocalcemia, hypophosphatemia, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase.

  15. Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q2W Regimen [ Time Frame: Baseline and Day 1 of Cycle 1 ]
    Participants who experienced urinalysis laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with urinalysis laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above.

  16. Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q2W Regimen [ Time Frame: From baseline to end of treatment (approximately 19 months). ]
    Participants who experienced coagulation laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with coagulation laboratory abnormalities that were shifted from <=Grade 2 at baseline to Grade 3 or above, including the following parameter: prothrombin time international normalized ratio.


Secondary Outcome Measures :
  1. Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimen [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). ]
    Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06647020 was determined using linear/log trapezoidal method.

  2. Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimen [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). ]
    Cmax is maximum observed serum concentration. Cmax for PF-06647020 was observed directly from data.

  3. Clearance (CL) for PF-06647020 - Q3W Regimen [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). ]
    Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance for PF-06647020 was calculated as dose/AUCinf for single dose and dose/AUCtau for multiple dose, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time and AUCtau was the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing).

  4. Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimen [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). ]
    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.

  5. Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimen [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). ]
    Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.

  6. Observed Accumulation Ratio (Rac) for PF-06647020 - Q3W Regimen [ Time Frame: pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle). ]
    Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).

  7. Time for Cmax (Tmax) for PF-06647020 - Q3W Regimen [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). ]
    Tmax is the time for Cmax. Tmax for PF-06647020 was observed directly from data as time of first occurrence.

  8. Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimen [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). ]
    AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06647020 was determined using linear/log trapezoidal method.

  9. Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimen [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). ]
    AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for PF-06647020 was calculated as AUClast + (Clast*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

  10. AUCtau for PF-06380101 - Q3W Regimen [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). ]
    Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06380101 was determined using linear/log trapezoidal method.

  11. Cmax for PF-06380101 - Q3W Regimen [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). ]
    Cmax is maximum observed serum concentration. Cmax for PF-06380101 was observed directly from data.

  12. t1/2 for PF-06380101 - Q3W Regimen [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). ]
    Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.

  13. Rac for PF-06380101 - Q3W Regimen [ Time Frame: pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle). ]
    Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).

  14. Tmax for PF-06380101 - Q3W Regimen [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). ]
    Tmax is the time for Cmax. Tmax for PF-06380101 was observed directly from data as time of first occurrence.

  15. AUClast for PF-06380101 - Q3W Regimen [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). ]
    AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06380101 was determined using linear/log trapezoidal method.

  16. AUCinf for PF-06380101 - Q3W Regimen [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). ]
    AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for PF-06380101 was calculated as AUClast + (Clast*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

  17. AUCtau for hu6M024 mAb - Q3W Regimen [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). ]
    Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for hu6M024 mAb was determined using linear/log trapezoidal method.

  18. Cmax for hu6M024 mAb - Q3W Regimen [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). ]
    Cmax is maximum observed serum concentration. Cmax for hu6M024 mAb was observed directly from data.

  19. t1/2 for hu6M024 mAb - Q3W Regimen [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). ]
    Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.

  20. Rac for hu6M024 mAb - Q3W Regimen [ Time Frame: pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle). ]
    Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).

  21. Tmax for hu6M024 mAb - Q3W Regimen [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). ]
    Tmax is the time for Cmax. Tmax for hu6M024 mAb was observed directly from data as time of first occurrence.

  22. AUClast for hu6M024 mAb - Q3W Regimen [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). ]
    AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for hu6M024 mAb was determined using linear/log trapezoidal method.

  23. AUCinf for hu6M024 mAb - Q3W Regimen [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). ]
    AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for hu6M024 mAb was calculated as AUClast + (Clast*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

  24. Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen [ Time Frame: Prior to the start of treatment on Day 1 of Cycle 1 up to end of treatment (approximately 31 months). ]
    To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06647020.

  25. Percentage of Participants With Objective Response - Q3W Regimen [ Time Frame: Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months). ]
    Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.

  26. Duration of Response - Q3W Regimen [ Time Frame: Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months). ]
    Duration of response (DoR) was the time from first documentation of PR or CR to date of first documentation of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.

  27. Disease Control Rate - Q3W Regimen [ Time Frame: Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months). ]
    The disease control rate (DCR) was defined as the percentage of participants with a confirmed CR, PR, non-CR/non-PD or stable disease (SD) according to the appropriate analysis set. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

  28. Time to Progression - Q3W Regimen [ Time Frame: Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months). ]
    Time to progression (TTP) was the time from start date to the date of the first documentation of PD. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.

  29. Progression Free Survival - Q3W Regimen [ Time Frame: Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months). ]
    Progression free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.

  30. Dose Normalized AUCinf [AUCinf(dn)] for PF-06647020 [DDI Sub-Study] [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). ]
    AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose.

  31. Dose Normalized AUClast [AUClast(dn)] for PF-06647020 [DDI Sub-Study] [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). ]
    AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose.

  32. Dose Normalized AUCtau [AUCtau(dn)] for PF-06647020 [DDI Sub-Study] [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). ]
    AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose.

  33. Dose Normalized Cmax [Cmax(dn)] for PF-06647020 [DDI Sub-Study] [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). ]
    Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.

  34. AUCinf(dn) for PF-06380101 [DDI Sub-Study] [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). ]
    AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose.

  35. AUClast(dn) for PF-06380101 [DDI Sub-Study] [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). ]
    AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose.

  36. AUCtau(dn) for PF-06380101 [DDI Sub-Study] [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). ]
    AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose.

  37. Cmax(dn) for PF-06380101 [DDI Sub-Study] [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). ]
    Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.

  38. AUCinf(dn) for hu6M024 mAb [DDI Sub-Study] [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). ]
    AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose.

  39. AUClast(dn) for hu6M024 mAb [DDI Sub-Study] [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). ]
    AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose.

  40. AUCtau(dn) for hu6M024 mAb [DDI Sub-Study] [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). ]
    AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose.

  41. Cmax(dn) for hu6M024 mAb [DDI Sub-Study] [ Time Frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). ]
    Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.

  42. AUCtau for PF-06647020 - Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). ]
    Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06647020 was determined using linear/log trapezoidal method.

  43. Cmax for PF-06647020 -Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). ]
    Cmax is maximum observed serum concentration. Cmax for PF-06647020 was observed directly from data.

  44. Vss for PF-06647020 - Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). ]
    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.

  45. CL for PF-06647020 - Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). ]
    Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance for PF-06647020 was calculated as dose/AUCinf for single dose and dose/AUCtau for multiple dose, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time and AUCtau was the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing).

  46. t1/2 for PF-06647020 - Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). ]
    Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.

  47. Rac for PF-06647020 - Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle). ]
    Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).

  48. Tmax for PF-06647020 - Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). ]
    Tmax is the time for Cmax. Tmax for PF-06647020 was observed directly from data as time of first occurrence.

  49. AUClast for PF-06647020 - Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). ]
    AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06647020 was determined using linear/log trapezoidal method.

  50. AUCinf for PF-06647020 - Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). ]
    AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

  51. AUCtau for PF-06380101 - Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). ]
    Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06380101 was determined using linear/log trapezoidal method.

  52. Cmax for PF-06380101 - Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). ]
    Cmax is maximum observed serum concentration. Cmax for PF-06380101 was observed directly from data.

  53. t1/2 for PF-06380101 - Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). ]
    Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.

  54. Rac for PF-06380101 - Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle). ]
    Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).

  55. Tmax for PF-06380101 - Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). ]
    Tmax is the time for Cmax. Tmax for PF-06380101 was observed directly from data as time of first occurrence.

  56. AUClast for PF-06380101- Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). ]
    AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06380101 was determined using linear/log trapezoidal method.

  57. AUCinf for PF-06380101- Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). ]
    AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

  58. AUCtau for hu6M024 mAb- Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). ]
    Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for hu6M024 mA was determined using linear/log trapezoidal method.

  59. Cmax for hu6M024 mAb -Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). ]
    Cmax is maximum observed serum concentration. Cmax for hu6M024 mAb was observed directly from data.

  60. t1/2 for hu6M024 mAb - Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). ]
    Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.

  61. Rac for hu6M024 mAb - Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle). ]
    Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau[dn]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).

  62. Tmax for hu6M024 mAb - Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). ]
    Tmax is the time for Cmax. Tmax for hu6M024 mAb was observed directly from data as time of first occurrence.

  63. AUClast for hu6M024 mAb - Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). ]
    AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for hu6M024 mAb was determined using linear/log trapezoidal method.

  64. AUCinf for hu6M024 mAb - Q2W Regimen [ Time Frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). ]
    AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

  65. Number of Participants With ADA and NAb of PF-06647020 - Q2W Regimen [ Time Frame: 2 hours before the first dose up to 30 days after the last dose (approximately 18 months). ]
    To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06647020.

  66. Percentage of Participants With Objective Response - Q2W Regimen [ Time Frame: Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months). ]
    Percentage of participants with objective response based on assessment of CR or PR according to RECIST version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.

  67. Duration of Response - Q2W Regimen [ Time Frame: Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months). ]
    For participants with an objective response, duration of response (DoR) was the time from first documentation of PR or CR to date of first documentation of PD or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.

  68. Disease Control Rate - Q2W Regimen [ Time Frame: Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months). ]
    The disease control rate (DCR) was defined as the percentage of participants with a confirmed CR, PR or SD according to the appropriate analysis set. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

  69. Time to Progression - Q2W Regimen [ Time Frame: Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months). ]
    Time to progression (TTP) was the time from start date to the date of the first documentation of PD. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.

  70. Progression Free Survival - Q2W Regimen [ Time Frame: Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months). ]
    Progression free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Q2W Inclusion Criteria:

  • Diagnosis of platinum resistant or refractory OVCA having received 2 or fewer prior lines, or recurrent advanced NSCLC having received 3 or fewer prior lines
  • Performance Status of 0, 1, or 2
  • Adequate bone marrow, kidney, and liver function

Q2W Exclusion Criteria:

  • OVCA pts excluded with any of the following: non-epithelial, including malignant mixed mullerian tumors, unresolved bowel obstruction
  • Brain metastases requiring steroids
  • Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start
  • Active and clinically significant bacterial, fungal, or viral infection

Q3W Inclusion Criteria:

  • Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available
  • Performance Status of 0 or 1
  • Adequate bone marrow, kidney, and liver function
  • Part 2 includes ovarian cancer, target expressing triple negative breast cancer and non small cell lung cancer patients

Q3W Exclusion Criteria:

  • OVCA pts excluded with any of the following: non-epithelial, including malignant mixed mullerian tumors, prior radiotherapy to pelvis/abdomen, pts with CA-125 only disease, unresolved bowel obstruction
  • Brain metastases requiring steroids
  • Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start
  • Active and clinically significant bacterial, fungal, or viral infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02222922


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
United States, Arizona
Scottsdale Healthcare Hospitals DBA HonorHealth
Scottsdale, Arizona, United States, 85258
United States, California
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
University of California Davis Medical Center
Sacramento, California, United States, 95817
Stanford Cancer Center
Stanford, California, United States, 94305
Stanford Hospital and Clinics
Stanford, California, United States, 94305
United States, Illinois
University of Chicago Medicine
Chicago, Illinois, United States, 60637
United States, Michigan
START Midwest
Grand Rapids, Michigan, United States, 49503
United States, Texas
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229
United States, Virginia
Inova Fairfax Hospital Woodburn GYN Infusion Center
Annandale, Virginia, United States, 22003
Mid Atlantic Gynecologic Oncology and Pelvic Surgery Associates (MAGOPSA)
Annandale, Virginia, United States, 22003
Fairfax Radiological Consultants
Fairfax, Virginia, United States, 22031
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Inova Loudon Hospital
Leesburg, Virginia, United States, 20176
Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Hospital Universitario Madrid Sanchinarro
Madrid, Spain, 28050
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] November 9, 2017
Statistical Analysis Plan  [PDF] December 4, 2018

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02222922    
Other Study ID Numbers: B7661001
2014-003296-36 ( EudraCT Number )
First Posted: August 22, 2014    Key Record Dates
Results First Posted: December 17, 2020
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
ADC
PF-06647020
solid tumors
tumors
neoplasm metastasis
TNBC
triple negative breast cancer
NSCLC
non small cell lung cancer
advanced metastatic breast cancer
ovarian cancer
OVCA
Additional relevant MeSH terms:
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Neoplasms
Fluconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors