A Study Of PF-06647263 In Patients With Advanced Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02078752
First received: March 3, 2014
Last updated: September 8, 2014
Last verified: September 2014

March 3, 2014
September 8, 2014
April 2014
October 2016   (final data collection date for primary outcome measure)
  • Number of participants with Dose-limiting toxicities (DLT) [ Time Frame: Baseline up to Cycle 2 Day 1 (22 days) ] [ Designated as safety issue: Yes ]
    First cycle DLTs in order to determine maximum tolerated dose
  • Number of Participants With Objective Response [Part 2] [ Time Frame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months ] [ Designated as safety issue: No ]
    Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.
Same as current
Complete list of historical versions of study NCT02078752 on ClinicalTrials.gov Archive Site
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Cycles 1 and 4, Day 1: pre-dose, 1, 4 and 24 hours post dose, Day 4, 8, and 15; Every other cycle, pre-dose and 0 hrs post dose. ] [ Designated as safety issue: No ]
    Tmax will be calculated for PF-06647263, total antibody and unconjugated payload
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Cycles 1 and 4, Day 1: pre-dose, 1, 4 and 24 hours post dose, Day 4, 8, and 15; Every other cycle, pre-dose and 0 hrs post dose. ] [ Designated as safety issue: No ]
    Cmax will be calculated for PF-06647263, total antibody and unconjugated payload
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: Cycles 1 and 4, Day 1: pre-dose, 1, 4 and 24 hours post dose, Day 4, 8, and 15; Every other cycle, pre-dose and 0 hrs post dose. ] [ Designated as safety issue: No ]
    AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
  • Systemic Clearance (CL) [ Time Frame: Cycles 1 and 4, Day 1: pre-dose, 1, 4 and 24 hours post dose, Day 4, 8, and 15; Every other cycle, pre-dose and 0 hrs post dose. ] [ Designated as safety issue: No ]
    CL is a quantitative measure of the rate at which a drug substance is removed from the body.
  • Volume of Distribution at Steady State (Vss) [ Time Frame: Cycles 1 and 4, Day 1: pre-dose, 1, 4 and 24 hours post dose, Day 4, 8, and 15; Every other cycle, pre-dose and 0 hrs post dose. ] [ Designated as safety issue: No ]
    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.
  • Plasma Decay Half-Life (t1/2) [ Time Frame: Cycles 1 and 4, Day 1: pre-dose, 1, 4 and 24 hours post dose, Day 4, 8, and 15; Every other cycle, pre-dose and 0 hrs post dose. ] [ Designated as safety issue: No ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Incidence of anti-drug antibodies [ Time Frame: Day 1 of every cycle pre-dose, and Day 15 of Cycle 1. ] [ Designated as safety issue: Yes ]
    Number of participants with the presence of anti-PF-06647263 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 ] [ Designated as safety issue: No ]
    Number of participants with objective response based on assessment of overall response rate (ORR), clinical benefit response rate (CBRR), progression free survival, and overall survival according to RECIST.
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Cycles 1 and 4, Day 1: pre-dose, 0, 4 and 24 hours post dose, Day 4, 8, and 15; Every other cycle, pre-dose and 0 hrs post dose. ] [ Designated as safety issue: No ]
    Tmax will be calculated for PF-06647263, total antibody and unconjugated payload
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Cycles 1 and 4, Day 1: pre-dose, 0, 4 and 24 hours post dose, Day 4, 8, and 15; Every other cycle, pre-dose and 0 hrs post dose. ] [ Designated as safety issue: No ]
    Cmax will be calculated for PF-06647263, total antibody and unconjugated payload
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: Cycles 1 and 4, Day 1: pre-dose, 0, 4 and 24 hours post dose, Day 4, 8, and 15; Every other cycle, pre-dose and 0 hrs post dose. ] [ Designated as safety issue: No ]
    AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
  • Systemic Clearance (CL) [ Time Frame: Cycles 1 and 4, Day 1: pre-dose, 0, 4 and 24 hours post dose, Day 4, 8, and 15; Every other cycle, pre-dose and 0 hrs post dose. ] [ Designated as safety issue: No ]
    CL is a quantitative measure of the rate at which a drug substance is removed from the body.
  • Volume of Distribution at Steady State (Vss) [ Time Frame: Cycles 1 and 4, Day 1: pre-dose, 0, 4 and 24 hours post dose, Day 4, 8, and 15; Every other cycle, pre-dose and 0 hrs post dose. ] [ Designated as safety issue: No ]
    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.
  • Plasma Decay Half-Life (t1/2) [ Time Frame: Cycles 1 and 4, Day 1: pre-dose, 0, 4 and 24 hours post dose, Day 4, 8, and 15; Every other cycle, pre-dose and 0 hrs post dose. ] [ Designated as safety issue: No ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Incidence of anti-drug antibodies [ Time Frame: Day 1 of every cycle pre-dose, and Day 15 of Cycle 1. ] [ Designated as safety issue: Yes ]
    Number of participants with the presence of anti-PF-06647263 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 ] [ Designated as safety issue: No ]
    Number of participants with objective response based on assessment of overall response rate (ORR), clinical benefit response rate (CBRR), progression free survival, and overall survival according to RECIST.
Not Provided
Not Provided
 
A Study Of PF-06647263 In Patients With Advanced Solid Tumors
A First-In-Human Phase 1, Dose Escalation, Safety And Pharmacokinetic Study Of PF-06647263 In Adult Patients With Advanced Solid Tumors

To assess the safety and tolerability at increasing dose levels of PF-06647263 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
  • Drug: PF-06647263
    Part 1- PF-06647263 will be administered intravenously in either a 21 day cycle or weekly in cohorts of 2 or more patients starting at a dose of 0.015 mg/kg. Increases in dose will continue until MTD is determined.
  • Drug: PF-06647263
    Part 2- Patients with select tumor types (triple negative breast cancer and ovarian cancer) will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.
Experimental: Part 1
Interventions:
  • Drug: PF-06647263
  • Drug: PF-06647263
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
October 2016
October 2016   (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 target expressing triple negative breast cancer or advanced epithelial ovarian cancer patients

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States
 
NCT02078752
B7521001
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2014

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