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Trial record 1 of 1 for:    NCT02222922
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A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02222922
Recruitment Status : Active, not recruiting
First Posted : August 22, 2014
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE August 20, 2014
First Posted Date  ICMJE August 22, 2014
Last Update Posted Date June 19, 2019
Actual Study Start Date  ICMJE October 17, 2014
Estimated Primary Completion Date July 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2017)
  • Number of participants with Dose-limiting toxicities (DLT) {Part1} [ Time Frame: Day 1 up to Day 21 ]
    First cycle DLTs in order to determine maximum tolerated dose
  • Number of Q2W participants with Dose-limiting toxicities (DLT) {Part1} [ Time Frame: Day 1 up to Day 28 ]
    First cycle DLTs in order to determine maximum tolerated dose
Original Primary Outcome Measures  ICMJE
 (submitted: August 21, 2014)
Number of participants with Dose-limiting toxicities (DLT) {Part1} [ Time Frame: Day 1 up to Day 21 ]
First cycle DLTs in order to determine maximum tolerated dose
Change History Complete list of historical versions of study NCT02222922 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2017)
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-06647020 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Maximum Observed Concentration (Cmax) for PF-06647020 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Systemic Clearance (CL) for PF-06647020 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Volume of distribution at steady state (Vss) for PF-06647020 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Terminal half-life (t1/2) for PF-06647020 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Accumulation ratio (Rac) for PF-06647020 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Time to Reach Maximum Observed Concentration (Tmax) for PF-06647020 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for PF-06647020 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Incidence of anti-drug antibodies [ Time Frame: Days 1, 15, 21, and every 21 days thereafter up to 24 months ]
    Number of participants with the presence of anti-PF-06647020 antibodies
  • Number of participants with objective response (Part 1) [ Time Frame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months ]
    Number of participants with objective response based on assessment of response rate (RR)
  • Number of participants with objective response (Part 2) [ Time Frame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months ]
    Number of participants with objective response based on assessment of overall response rate (ORR) and progression free survival (PFS)
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-06380101 [DDI sub-study] [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Maximum Observed Concentration (Cmax) for PF-06380101 [DDI sub-study] [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Systemic Clearance (CL) for PF-06380101 [DDI sub-study] [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Terminal half-life (t1/2) for PF-06380101 [DDI sub-study] [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-06380101 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Maximum Observed Concentration (Cmax) for PF-06380101 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Volume of distribution at steady state (Vss) for PF-06380101 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Terminal half-life (t1/2) for PF-06380101 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Accumulation ratio (Rac) for PF-06380101 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Time to Reach Maximum Observed Concentration (Tmax) for PF-06380101 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for PF-06380101 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for hu6M024 mAb [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Maximum Observed Concentration (Cmax) for hu6M024 mAb [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Systemic Clearance (CL) for hu6M024 mAb [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Volume of distribution at steady state (Vss) for hu6M024 mAb [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Terminal half-life (t1/2) for hu6M024 mAb [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Accumulation ratio (Rac) for hu6M024 mAb [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Time to Reach Maximum Observed Concentration (Tmax) for hu6M024 mAb [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for hu6M024 mAb [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-06647020 [DDI sub-study] [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Maximum Observed Concentration (Cmax) for PF-06647020 [DDI sub-study] [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Volume of distribution at steady state (Vss) for PF-06647020 [DDI sub-study] [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Terminal half-life (t1/2) for PF-06647020 [DDI sub-study] [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for hu6M024 mAb [DDI sub-study] [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Maximum Observed Concentration (Cmax) for hu6M024 mAb [DDI sub-study] [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Volume of distribution at steady state (Vss) for hu6M024 mAb [DDI sub-study] [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Terminal half-life (t1/2) for hu6M024 mAb [DDI sub-study] [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-06647020 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Maximum Observed Concentration (Cmax) for PF-06647020 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Systemic Clearance (CL) for PF-06647020 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Volume of distribution at steady state (Vss) for PF-06647020 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Terminal half-life (t1/2) for PF-06647020 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Accumulation ratio (Rac) for PF-06647020 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Time to Reach Maximum Observed Concentration (Tmax) for PF-06647020 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for PF-06647020 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Incidence of anti-drug antibodies [ Time Frame: Days 1, 15, 28, and every 28 days thereafter up to 24 months ]
    Number of participants with the presence of anti-PF-06647020 antibodies
  • Number of Q2W participants with objective response (single agent) [ Time Frame: Baseline, every 8 weeks until disease progression or unacceptable toxicity up to 24 months ]
    Number of participants with objective response based on assessment of response rate (RR)
  • Number of combination participants with objective response (PF-06647020 + avelumab) [ Time Frame: Baseline, every 8 weeks until disease progression or unacceptable toxicity up to 24 months ]
    Number of participants with objective response based on assessment of overall response rate (ORR) and progression free survival (PFS)
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-06380101 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Maximum Observed Concentration (Cmax) for PF-06380101 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Systemic Clearance (CL) for PF-06380101 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Volume of distribution at steady state (Vss) for PF-06380101 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Terminal half-life (t1/2) for PF-06380101 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Accumulation ratio (Rac) for PF-06380101 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Time to Reach Maximum Observed Concentration (Tmax) for PF-06380101 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for PF-06380101 [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for hu6M024 mAb [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Maximum Observed Concentration (Cmax) for hu6M024 mAb [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Systemic Clearance (CL) for hu6M024 mAb [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Volume of distribution at steady state (Vss) for hu6M024 mAb [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Terminal half-life (t1/2) for hu6M024 mAb [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Accumulation ratio (Rac) for hu6M024 mAb [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Time to Reach Maximum Observed Concentration (Tmax) for hu6M024 mAb [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for hu6M024 mAb [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 28 days thereafter for up to 24 months ]
  • Incidence of anti-drug antibodies (avelumab) [ Time Frame: Days 1, 15, 28, and every 28 days thereafter up to 24 months ]
    Number of participants with the presence of anti-avelumab antibodies
Original Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2014)
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Systemic Clearance (CL) [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
    CL is a quantitative measure of the rate at which a drug substance is removed from the body.
  • Volume of distribution (Vd) [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Accumulation ratio (Rac) [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: Scheduled timepoints from Day 1 up to Day 84 and then every 21 days thereafter for up to 24 months ]
    AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
  • Incidence of anti-drug antibodies [ Time Frame: Days 1, 15, 21, and every 21 days thereafter up to 24 months ]
    Number of participants with the presence of anti-PF-06647020 antibodies
  • Number of participants with objective response (Part 1) [ Time Frame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months ]
    Number of participants with objective response based on assessment of response rate (RR)
  • Number of participants with objective response (Part 2) [ Time Frame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months ]
    Number of participants with objective response based on assessment of overall response rate (ORR) and progression free survival (PFS)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors
Official Title  ICMJE A FIRST-IN-HUMAN PHASE 1, DOSE ESCALATION, SAFETY AND PHARMACOKINETIC STUDY OF PF-06647020 IN ADULT PATIENTS WITH ADVANCED SOLID TUMORS
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms
Intervention  ICMJE
  • 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.

  • Drug: fluconazole
    combination drug used for drug-drug interaction sub-study
  • 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.

  • Drug: PF-06647020 combined with Avelumab
    Part 2: Patients with ovarian cancer (unselected for PTK7 expression) will be treated with PF-0664702 plus Avelumab.
Study Arms  ICMJE
  • Experimental: PF-06647020 Q3W
    Investigational drug infused over 60 minutes once every 21 days.
    Intervention: Drug: PF-06647020 Q3W
  • Experimental: Drug-drug interaction (DDI)
    PF-06647020 combined with fluconazole
    Intervention: Drug: fluconazole
  • Experimental: PF-06647020 Q2W
    Investigational drug infused over 60 minutes once every 14 days (28 day cycle)
    Intervention: Drug: PF-06647020 Q2W
  • Experimental: PF-06647020 combined with Avelumab
    PF-06647020 combined with Avelumab administered by infusion
    Intervention: Drug: PF-06647020 combined with Avelumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 15, 2019)
138
Original Estimated Enrollment  ICMJE
 (submitted: August 21, 2014)
82
Estimated Study Completion Date  ICMJE July 29, 2019
Estimated Primary Completion Date July 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02222922
Other Study ID Numbers  ICMJE B7661001
2014-003296-36 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP