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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02078752
First received: March 3, 2014
Last updated: October 30, 2014
Last verified: October 2014
  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
Drug: PF-06647263
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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) ] [ 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.


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. ] [ 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.


Estimated Enrollment: 100
Study Start Date: April 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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
  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

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
United States, Massachusetts
Brigham & Women's Hospital (BWH) Recruiting
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute (DFCI) Recruiting
Boston, Massachusetts, United States, 02215
United States, Tennessee
Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37203
Tennessee Oncology, PPLC Recruiting
Nashville, Tennessee, United States, 37203
The Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Hospital / University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
University of Utah, Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02078752     History of Changes
Other Study ID Numbers: B7521001
Study First Received: March 3, 2014
Last Updated: October 30, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 30, 2014