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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02078752
First received: March 3, 2014
Last updated: May 22, 2017
Last verified: May 2017
  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.

Condition Intervention Phase
Neoplasms Triple-Negative Breast Cancer Drug: PF-06647263 Phase 1

Study Type: Interventional
Study Design: Masking: No masking
Primary Purpose: Treatment
Official Title: A First-in-human Phase 1, Dose Escalation, Safety And Pharmacokinetic Study Of Pf-06647263 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) [ Time Frame: Baseline up to Cycle 2 Day 1 (22 days) ]
    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 ]
    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.


Secondary Outcome Measures:
  • 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. ]
    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. ]
    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. ]
    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. ]
    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. ]
    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. ]
    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. ]
    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 ]
    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.


Estimated Enrollment: 109
Actual Study Start Date: April 2014
Estimated Study Completion Date: May 2017
Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1 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 triple negative breast cancer will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.

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).
  Eligibility

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 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02078752

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham & Women's Hospital (BWH)
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Nevada
Comprehensive Cancer Centers Of Nevada
Las Vegas, Nevada, United States, 89169
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Hospital / University of Utah
Salt Lake City, Utah, United States, 84112
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Washington
LabCorp
Redmond, Washington, United States, 98052-1022
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02078752     History of Changes
Other Study ID Numbers: B7521001
Study First Received: March 3, 2014
Last Updated: May 22, 2017

Keywords provided by Pfizer:
ADC
PF-06647263
solid tumors
tumors
neoplasm metastasis
TNBC
Triple negative breast cancer

Additional relevant MeSH terms:
Triple Negative Breast Neoplasms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 23, 2017