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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02222922
First received: August 20, 2014
Last updated: June 8, 2017
Last verified: June 2017
August 20, 2014
June 8, 2017
October 2014
July 2019   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02222922 on ClinicalTrials.gov Archive Site
  • 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)
  • 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)
Not Provided
Not Provided
 
A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors
A First-in-human Phase 1, Dose Escalation, Safety And Pharmacokinetic Study Of Pf-06647020 In Adult Patients With Advanced Solid Tumors
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Masking: No masking
Primary Purpose: Treatment
Neoplasms
  • 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.
  • Drug: fluconazole
    combination drug used for drug-drug interaction sub-study
  • Experimental: PF-06647020
    Investigational drug infused over 60 minutes once every 21 days.
    Interventions:
    • Drug: PF-06647020
    • Drug: PF-06647020
  • Experimental: Drug-drug interaction
    PF-06647020 combined with fluconazole
    Interventions:
    • Drug: PF-06647020
    • Drug: fluconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
190
July 2019
July 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain,   United States
 
 
NCT02222922
B7661001
2014-003296-36 ( EudraCT Number )
No
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2017

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