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NCT Number: NCT02222922

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

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.

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Key information

Conditions

Neoplasms Adnexal Diseases Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms by Site Neoplastic Processes Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Triple Negative Breast Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital Universitario Fundacion Jimenez Diaz, Madrid, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-06647020 Q3W

Drug

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.

Fluconazole

Drug

combination drug used for drug-drug interaction sub-study

PF-06647020 Q2W

Drug

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 combined with Avelumab

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Aug 22, 2014
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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