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

This study is currently recruiting participants.
Verified September 2017 by Pfizer
Sponsor:
ClinicalTrials.gov Identifier:
NCT02222922
First Posted: August 22, 2014
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
To assess the safety and tolerability at increasing dose levels of PF-06647020 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Condition Intervention Phase
Neoplasms Drug: PF-06647020 Drug: fluconazole Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A First-in-human Phase 1, Dose Escalation, Safety And Pharmacokinetic Study Of Pf-06647020 In Adult Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 Plasma 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 ]
    CL is a quantitative measure of the rate at which a drug substance is removed from the body.

  • Volume of distribution (Vd) 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 ]
  • Plasma Decay 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 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  • 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 Plasma 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 ]
    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)

  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-06380101 when PF-06647020 is combined with fluconazole [ 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) for PF-06380101 when PF-06647020 is combined with fluconazole [ 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 when PF-06647020 is combined with fluconazole [ 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) for PF-06380101 when PF-06647020 is combined with fluconazole [ 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) for PF-06380101 when PF-06647020 is combined with fluconazole [ 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) for PF-06380101 when PF-06647020 is combined with fluconazole [ 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) for PF-06380101 when PF-06647020 is combined with fluconazole [ 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 when PF-06647020 is combined with fluconazole [ 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)

  • 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 Plasma 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 ]
  • Systemic Clearance (CL) 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 ]
    CL is a quantitative measure of the rate at which a drug substance is removed from the body.

  • Volume of distribution (Vd) 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 ]
  • Plasma Decay 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 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  • 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 Plasma 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 ]
    AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

  • 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 Plasma 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 ]
    CL is a quantitative measure of the rate at which a drug substance is removed from the body.

  • Volume of distribution (Vd) 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 ]
  • Plasma Decay 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 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  • 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 Plasma 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 ]
    AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-06647020 when combined with fluconazole [ 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) for PF-06647020 when combined with fluconazole [ 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 when combined with fluconazole [ 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) for PF-06647020 when combined with fluconazole [ 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) for PF-06647020 when combined with fluconazole [ 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) for PF-06647020 when combined with fluconazole [ 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) for PF-06647020 when combined with fluconazole [ 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 when combined with fluconazole [ 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)

  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for hu6M024 mAb when combined with fluconazole [ 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) for hu6M024 mAb when combined with fluconazole [ 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 when combined with fluconazole [ 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) for hu6M024 mAb when combined with fluconazole [ 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) for hu6M024 mAb when combined with fluconazole [ 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) for hu6M024 mAb when combined with fluconazole [ 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) for hu6M024 mAb when combined with fluconazole [ 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 when combined with fluconazole [ 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)


Estimated Enrollment: 190
Actual Study Start Date: October 17, 2014
Estimated Study Completion Date: July 24, 2019
Estimated Primary Completion Date: July 24, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-06647020
Investigational drug infused over 60 minutes once every 21 days.
Drug: PF-06647020
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.
Drug: PF-06647020
Part 2: Patients with triple negative breast cancer (pre-selected for PTK7 moderately high to high expression), non small cell lung cancer (pre-selected with moderate to high PTK7 expression) and ovarian cancer patients (unselected for PTK7 expression) will be treated at the MTD or Recommended Phase 2 Dose selected in Part 1.
Experimental: Drug-drug interaction
PF-06647020 combined with fluconazole
Drug: PF-06647020
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

  Eligibility

Information from the National Library of Medicine

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


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

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
  • OVCA pts must have progressed while receiving or within 6mos after completion of at least 4 cycles of platinum-containing regimen. Prior line of therapy up to 3 regimens.

Exclusion Criteria:

  • OVCA pts excluded with any of the following: non-epithelial, inlcuding malignant mixed mullerian tumors, prior radiotherapy to pelvis/abdomen, pts with CA-125 only disease, unresolved bowel obstruction, including sub-occlusive disease, related to underlying disdease and history of abdominal fistula, GI perforation or itra-abdominal abscess.
  • Brain metastases requiring steroids
  • Drug-drug interaction includes advanced metastatic breast cancer, ovarian cancer, or non small cell lung cancer patients
  • 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
  Contacts and Locations
Information from the National Library of Medicine

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

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


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
United States, Arizona
Scottsdale Healthcare Hospitals DBA HonorHealth Recruiting
Scottsdale, Arizona, United States, 85258
Virginia G. Piper Cancer Center Pharmacy Recruiting
Scottsdale, Arizona, United States, 85258
United States, California
Clinical Translational Research Unit (CTRU) Recruiting
Palo Alto, California, United States, 94305
Stanford Cancer Center Recruiting
Stanford, California, United States, 94305
Stanford Hospital and Clinics Recruiting
Stanford, California, United States, 94305
United States, Illinois
The University of Chicago Medical Center, CCD Recruiting
Chicago, Illinois, United States, 60637
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
United States, Michigan
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
United States, Texas
South Texas Accelerated Research Therapeutics, LLC Active, not recruiting
San Antonio, Texas, United States, 78229
United States, Virginia
Fairfax Radiology Consultants- Woodburn Recruiting
Annandale, Virginia, United States, 22003
Inova Fairfax Hospital Woodburn GYN Infusion Center Recruiting
Annandale, Virginia, United States, 22003
Inova Fairfax Hospital Woodburn Pharmacy Recruiting
Annandale, Virginia, United States, 22003
Mid Atlantic Gynecologic Oncology and Pelvic Surgery Associates (MAGOPSA) Recruiting
Annandale, Virginia, United States, 22042
Inova Schar Cancer Institute Recruiting
Fairfax, Virginia, United States, 22031
Inova Loudon Hospital Recruiting
Leesburg, Virginia, United States, 20176
Spain
Hospital Universitario Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
Hospital Universitario Madrid Sanchinarro Recruiting
Madrid, Spain, 28050
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02222922     History of Changes
Other Study ID Numbers: B7661001
2014-003296-36 ( EudraCT Number )
First Submitted: August 20, 2014
First Posted: August 22, 2014
Last Update Posted: October 2, 2017
Last Verified: September 2017

Keywords provided by Pfizer:
ADC
PF-06647020
solid tumors
tumors
neoplasm metastasis
TNBC
triple negative breast cancer
NSCLC
non small cell lung cancer
advanced metastatic breast cancer
ovarian cancer
OVCA

Additional relevant MeSH terms:
Fluconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors