Clinical Trials /

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

NCT02078752

Description:

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.

Related Conditions:
  • Breast Carcinoma
  • Fallopian Tube Carcinoma
  • Malignant Solid Tumor
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study Of PF-06647263 In Patients With Advanced Solid Tumors
  • Official Title: A First-in-human Phase 1, Dose Escalation, Safety And Pharmacokinetic Study Of Pf-06647263 In Adult Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: B7521001
  • NCT ID: NCT02078752

Conditions

  • Neoplasms
  • Triple-Negative Breast Cancer

Interventions

DrugSynonymsArms
PF-06647263Part 1
PF-06647263Part 1

Purpose

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.

Detailed Description

      The clinical study will include 2 parts. Part 1 will estimate the MTD in dose escalation
      cohorts in patients with advanced solid tumors for whom no standard therapy is available in
      order to establish the RP2D. Part 2 will include patients with previously treated metastatic
      triple negative breast cancer (TNBC).
    

Trial Arms

NameTypeDescriptionInterventions
Part 1Experimental
  • PF-06647263
  • PF-06647263

Eligibility 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 advanced triple negative breast 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with Dose-limiting toxicities (DLT)
Time Frame:Baseline up to Cycle 2 Day 1 (22 days)
Safety Issue:
Description:First cycle DLTs in order to determine maximum tolerated dose

Secondary Outcome Measures

Measure: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.
Safety Issue:
Description:Tmax will be calculated for PF-06647263, total antibody and unconjugated payload
Measure: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.
Safety Issue:
Description:Cmax will be calculated for PF-06647263, total antibody and unconjugated payload
Measure: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.
Safety Issue:
Description:AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Measure: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.
Safety Issue:
Description:CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Measure: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.
Safety Issue:
Description: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.
Measure: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.
Safety Issue:
Description:Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measure:Incidence of anti-drug antibodies
Time Frame:Day 1 of every cycle pre-dose, and Day 15 of Cycle 1.
Safety Issue:
Description:Number of participants with the presence of anti-PF-06647263 antibodies
Measure:Number of participants with objective response [Part 1]
Time Frame:Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
Safety Issue:
Description:Number of participants with objective response based Objective tumor response, as assessed using RECIST version 1.1 by calculating the Overall Response Rate (ORR), Clinical Benefit Response Rate (CBRR), Progression Free Survival (PFS), and Overall Survival (OS)- in Part 2 only stratifying for EFNA4 expression.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Pfizer

Trial Keywords

  • ADC
  • PF-06647263
  • solid tumors
  • tumors
  • neoplasm metastasis
  • TNBC
  • Triple negative breast cancer

Last Updated

July 11, 2017