Study Of CP-751,871 In Patients With Ewing's Sarcoma Family Of Tumors

October 6, 2015 updated by: Pfizer

A Phase 1/Phase 2 Study Of CP-751,871 In Patients With Relapsed And/Or Refractory Ewing's Sarcoma Family Of Tumors

Define the efficacy of CP-751,871 in patients with Ewing's sarcoma family of tumors

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 2
  • 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

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Pfizer Investigational Site
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Pfizer Investigational Site
  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04023-062
        • Pfizer Investigational Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Pfizer Investigational Site
  • Chile
    • Santiago, RM
      • Providencia, Santiago, RM, Chile, 7500539
        • Pfizer Investigational Site
  • France
      • Lille Cedex, France, 59020
        • Pfizer Investigational Site
      • Lyon, France, 69373
        • Pfizer Investigational Site
      • Paris, France, 75005
        • Pfizer Investigational Site
      • Villejuif, France, 94805
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 13353
        • Pfizer Investigational Site
      • Freiburg, Germany, 79106
        • Pfizer Investigational Site
      • Muenchen, Germany, 80804
        • Pfizer Investigational Site
      • Muenster, Germany, 48149
        • Pfizer Investigational Site
  • Israel
      • Jerusalem, Israel, 91120
        • Pfizer Investigational Site
      • Petach Tikva, Israel, 49202
        • Pfizer Investigational Site
  • Italy
      • Bologna, Italy, 40136
        • Pfizer Investigational Site
      • Milano, Italy, 20133
        • Pfizer Investigational Site
      • Torino, Italy, 10126
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • Pfizer Investigational Site
      • Madrid, Spain, 28046
        • Pfizer Investigational Site
      • Valencia, Spain, 46026
        • Pfizer Investigational Site
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Spain, 08950
        • Pfizer Investigational Site
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • Pfizer Investigational Site
      • London, United Kingdom, NW1 2PG
        • Pfizer Investigational Site
      • Oxford, United Kingdom, OX3 9DU
        • Pfizer Investigational Site
      • Oxford, United Kingdom, OX3 7LJ
        • Pfizer Investigational Site
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Pfizer Investigational Site
  • United States
    • Florida
      • Tampa, Florida, United States, 33612-9497
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Pfizer Investigational Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10032
        • Pfizer Investigational Site
      • New York, New York, United States, 10065
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4399
        • Pfizer Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75235
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98105
        • 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

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ewing's family of tumors
  • Current disease state for which there is no curative therapy

Exclusion Criteria:

  • Prior anti-IGF-1R therapy
  • Concurrent treatment with other anti-cancer agents

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: CP-751,871
Final dose 30 mg/kg IV on Day 1 of each 28 day cycle until either progression or toxicity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Baseline and every cycle (4 weeks), for up to 6 cycles
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease and no new lesions. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions.
Baseline and every cycle (4 weeks), for up to 6 cycles

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Baseline and every cycle (4 weeks), until progression or death
PFS was the time in months from start date to date of first documentation of progression, death due to any cause or symptomatic deterioration (global deterioration of health status requiring discontinuation of treatment).
Baseline and every cycle (4 weeks), until progression or death
Overall Survival (OS)
Time Frame: Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment
Time in months from enrollment to death. For participants who are alive, overall survival was censored at the last contact.
Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1
Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1
Minimum Observed Plasma Trough Concentration (Cmin)
Time Frame: Cycle 6: predose on Day 1
Cmin is the concentration at the end of treatment cycle (next cycle predose).
Cycle 6: predose on Day 1
Plasma Concentration at End of Infusion (Cendinf)
Time Frame: Cycle 1 Day 2 and Cycle 5 Day 1
Cycle 1 Day 2 and Cycle 5 Day 1
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Time Frame: Cycle 5: 1 hour post-infusion on Day 1
The dosing interval was 1 cycle (4 weeks) in this study.
Cycle 5: 1 hour post-infusion on Day 1
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time Frame: Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1
AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.
Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1
Number of Participants With Positive Anti-Drug Antibody (ADA) Titer
Time Frame: Cycle 4 (predose on Day 1), 28 days after last dose (End-of-Treatment), and follow-up (approximately 150 days after last dose)
Number of participants with positive sample(s) in the ADA assay and in the neutralizing anti-drug antibodies (NAb) assay. An endpoint titer <6.64 corresponded to negative ADA category value.
Cycle 4 (predose on Day 1), 28 days after last dose (End-of-Treatment), and follow-up (approximately 150 days after last dose)

Collaborators and Investigators

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

Sponsor

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.

General Publications

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

March 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

November 15, 2007

First Submitted That Met QC Criteria

November 15, 2007

First Posted (Estimate)

November 19, 2007

Study Record Updates

Last Update Posted (Estimate)

October 28, 2015

Last Update Submitted That Met QC Criteria

October 6, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4021020

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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