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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00560235
First received: November 15, 2007
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: Baseline and every cycle (4 weeks), for up to 6 cycles ] [ Designated as safety issue: No ]
    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:
  • Progression-Free Survival (PFS) [ Time Frame: Baseline and every cycle (4 weeks), until progression or death ] [ Designated as safety issue: No ]
    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).

  • Overall Survival (OS) [ Time Frame: Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment ] [ Designated as safety issue: No ]
    Time in months from enrollment to death. For participants who are alive, overall survival was censored at the last contact.

  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1 ] [ Designated as safety issue: No ]
  • Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: Cycle 6: predose on Day 1 ] [ Designated as safety issue: No ]
    Cmin is the concentration at the end of treatment cycle (next cycle predose).

  • Plasma Concentration at End of Infusion (Cendinf) [ Time Frame: Cycle 1 Day 2 and Cycle 5 Day 1 ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) [ Time Frame: Cycle 5: 1 hour post-infusion on Day 1 ] [ Designated as safety issue: No ]
    The dosing interval was 1 cycle (4 weeks) in this study.

  • 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 ] [ Designated as safety issue: No ]
    AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.

  • 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) ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 138
Study Start Date: March 2008
Study Completion Date: October 2012
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
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
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: NCT00560235

  Hide Study Locations
Locations
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
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00560235     History of Changes
Other Study ID Numbers: A4021020
Study First Received: November 15, 2007
Results First Received: October 24, 2013
Last Updated: January 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Ewing
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Osteosarcoma

ClinicalTrials.gov processed this record on November 19, 2014