Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Breast Neoplasms

Triple Negative Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Avelumab

Fluconazole

Cofetuzumab pelidotin

Antineoplastic Agents, Immunological

Clotrimazole

Miconazole

Antifungal Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Hormones

Hormone Antagonists

Immunoconjugates

Immunologic Factors

Investigational drug infused over 60 minutes once every 21 days.

Investigational drug infused over 60 minutes once every 14 days (28 day cycle)

PF-06647020 combined with Avelumab administered by infusion

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.

PF-06647020 Q3W

combination drug used for drug-drug interaction sub-study

fluconazole

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

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

PF-06647020 Q2W

Part 2: Patients with ovarian cancer (unselected for PTK7 expression) will be treated with PF-0664702 plus Avelumab.

PF-06647020 combined with Avelumab

Pfizer CT.gov Call Center

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.

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

A FIRST-IN-HUMAN PHASE 1, DOSE ESCALATION, SAFETY AND PHARMACOKINETIC STUDY OF PF-06647020 IN ADULT PATIENTS WITH ADVANCED SOLID TUMORS

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Cmax is maximum observed serum concentration. Cmax for PF-06647020 was observed directly from data.

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).

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.

Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.

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).

Tmax is the time for Cmax. Tmax for PF-06647020 was observed directly from data as time of first occurrence.

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.

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.

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.

Cmax is maximum observed serum concentration. Cmax for PF-06380101 was observed directly from data.

Tmax is the time for Cmax. Tmax for PF-06380101 was observed directly from data as time of first occurrence.

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.

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.

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.

Cmax is maximum observed serum concentration. Cmax for hu6M024 mAb was observed directly from data.

Tmax is the time for Cmax. Tmax for hu6M024 mAb was observed directly from data as time of first occurrence.

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.

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.

To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06647020.

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.

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.

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.

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.

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.

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.

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.

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.

Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.

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.

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).

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).

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.

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.

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.

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.

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.

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.

Pfizer

MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.

Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.

PF-06647020 0.2 mg/kg (Q3W Regimen)

Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.

PF-06647020 0.5 mg/kg (Q3W Regimen)

Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.

PF-06647020 1.25 mg/kg (Q3W Regimen)

Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.

PF-06647020 2.1 mg/kg (Q3W Regimen)

Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.

PF-06647020 2.8 mg/kg (Q3W Regimen)

Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.

PF-06647020 3.7 mg/kg (Q3W Regimen)

Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.

PF-06647020 2.1 mg/kg (Q2W Regimen)

Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.

PF-06647020 2.8 mg/kg (Q2W Regimen)

Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.

PF-06647020 3.2 mg/kg (Q2W Regimen)

Total

Q3W Regimen

Q2W Regimen

Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.

Age, Continuous

< 18 (Q3W Regimen)

18-44 (Q3W Regimen)

45-64 (Q3W Regimen)

>= 65 (Q3W Regimen)

< 18 (Q2W Regimen)

18-44 (Q2W Regimen)

45-64 (Q2W Regimen)

>= 65 (Q2W Regimen)

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

Weight Continuous

Body Mass Index (BMI) Continuous

Baseline analysis population included all enrolled participants who received at least 1 full or partial dose of study medication.

Pfizer ClinicalTrials.gov Call Center

Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

PF-06647020 0.2 mg/kg（Q3W Regimen）

Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

Participants enrolled in the dose escalation phase in Q3W regimen who received at least 1 dose of study medication and who did not have major treatment deviations during first cycle with a baseline disease assessment and at least 1 post-baseline disease assessment.

Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen

SAEs

All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication.

Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)

Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)

Grade 1 (all-causality)

Grade 2 (all-causality)

Grade 3 (all-causality)

Grade 4 (all-causality)

Grade 5 (all-causality)

Missing or Unknown (all-causality)

Grade 1 (treatment-related)

Grade 2 (treatment-related)

Grade 3 (treatment-related)

Grade 4 (treatment-related)

Grade 5 (treatment-related)

Missing or Unknown (treatment-related)

Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)

Absolute neutrophils

Lymphopenia

White blood cells

Anemia

Platelets

All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given hematology laboratory test.

Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen

Hypokalemia

Hypophosphatemia

Aspartate aminotransferase

Hyperglycemia

Alkaline phosphatase

Hyponatremia

Alanine aminotransferase

Hypoalbuminemia

Total bilirubin

Hypercalcemia

Hypomagnesemia

Creatinine

Gamma glutamyl transferase

Hypocalcemia

All participants enrolled in Q3W who received at least 1 full or partial dose of study medication and had at least 1 observation of the given chemistry laboratory test.

Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen

All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given urinalysis laboratory test.

Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen

All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given coagulation laboratory test.

Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen

All participants enrolled in Q2W regimen who received at least 1 dose of study medication and who did not have major treatment deviations during first cycle with a baseline disease assessment and at least 1 post baseline disease assessment.

Number of Participants With DLTs - Q2W Regimen

All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication.

Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality)

Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related)

Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)

All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given hematology laboratory test.

Spots Global Cancer Trial Database for A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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