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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: November 8, 2012
Last verified: November 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety and efficacy, in terms of objective response, of CP-751,871 in this patient population [ Time Frame: 20 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 20 months ] [ Designated as safety issue: No ]
  • PK [ Time Frame: 20 months ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: 20 months ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 30 months ] [ Designated as safety issue: No ]

Enrollment: 139
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560235

  Show 37 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sarcoma, Ewing's
Neuroectodermal Tumors, Primitive, Peripheral
Sarcoma
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
 Neoplasms
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on June 17, 2013