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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00560235
Recruitment Status : Completed
First Posted : November 19, 2007
Results First Posted : February 28, 2014
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
Define the efficacy of CP-751,871 in patients with Ewing's sarcoma family of tumors

Condition or disease Intervention/treatment Phase
Ewing's Sarcoma Family of Tumors Drug: CP-751,871 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/Phase 2 Study Of CP-751,871 In Patients With Relapsed And/Or Refractory Ewing's Sarcoma Family Of Tumors
Study Start Date : March 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1 ]
  4. 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).

  5. Plasma Concentration at End of Infusion (Cendinf) [ Time Frame: Cycle 1 Day 2 and Cycle 5 Day 1 ]
  6. 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.

  7. 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.

  8. 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.


Eligibility Criteria
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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560235


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00560235    
Other Study ID Numbers: A4021020
First Posted: November 19, 2007    Key Record Dates
Results First Posted: February 28, 2014
Last Update Posted: October 28, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Sarcoma
Sarcoma, Ewing
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
 Neoplasms
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue