A Safety And Efficacy Study Of The Combination Of Oral PF-00299804 And Intravenous CP-751,871 Given Every 3 Weeks

April 18, 2024 updated by: Pfizer

Phase 1 Targeted Combination Trial Of PF-00299804 And CP-751,871 In Patients With Advanced Solid Tumors

This study will explore the combination of the oral drug PF-00299804 and intravenous CP-751,871 in patients with advanced solid tumor. Each of these drugs have been given separately to patients in prior studies, and this study is to establish the safety and efficacy of the combination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Villejuif, France, 94805
        • Pfizer Investigational Site
  • Spain
      • Madrid, Spain, 28050
        • Pfizer Investigational Site
  • United States
    • New York
      • Amherst, New York, United States, 14221
        • Pfizer Investigational Site
      • Buffalo, New York, United States, 14263
        • Pfizer Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically documented advanced cancer, Eastern Cooperative Oncology Group (ECOG) 0-1;
  • Platelets > 100,000, ANC > 1500;
  • Ccr > 60 or serum creat. <1.5
  • Non-small cell cancer cohort:
  • Eastern Cooperative Oncology Group (ECOG) 0-2, prior platin, < 4 prior chemotherapy regimen
  • HgA1C <5.7%

Exclusion Criteria:

  • Active Central Nervous System (CNS) metastases;
  • prior IGF1-R targeted therapy
  • Any history of unstable angina, myocardial infarction or symptomatic congestive heart failure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: PF-00299804
CP-751,871 at recommended dose on Day 1 and 2 of cycle 1, then on Day 1 every 3 weeks; and PF-00299804 orally at recommended dose once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall safety profile characterized by type, frequency, severity (as graded using NCI CTC AE v. 3.0), timing, seriousness and relationship to trial treatment of adverse events and laboratory abnormalities.
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma Pharmacokinetic Parameters of PF-00299804 and CP-751,871
Time Frame: 12 months
12 months
Progression Free Survival (PFS)
Time Frame: 15 months
15 months
Best overall response (OR) defined according to RECIST guidelines.
Time Frame: 12 months
12 months
Duration of response (DR)
Time Frame: 15 months
15 months
Anti-Drug Antibodies (ADA) response;
Time Frame: 18 months
18 months
KRAS mutation and EGFR gene amplification and mutation status in available NSCLC tumor tissue (fresh or archived) (NSCLC MTD Expansion Cohort
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2008

Primary Completion (Actual)

August 9, 2011

Study Completion (Actual)

January 29, 2013

Study Registration Dates

First Submitted

July 31, 2008

First Submitted That Met QC Criteria

August 4, 2008

First Posted (Estimated)

August 5, 2008

Study Record Updates

Last Update Posted (Estimated)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A7471004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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