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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00560235

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 I Phase II

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

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: 30 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Time Frame: 30 months ] [ Designated as safety issue: No ]
PK [ Time Frame: 30 months ] [ Designated as safety issue: No ]
Progression Free Survival [ Time Frame: 30 months ] [ Designated as safety issue: No ]
Survival [ Time Frame: 30 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	March 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: CP-751,871 Final dose TBD mg/kg (pending on phase 1 escalation portion of the study), IV on Day 1 of each 28 day cycle until either progression or toxicity

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

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

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4021020
Study First Received:	November 15, 2007
Last Updated:	January 4, 2009
ClinicalTrials.gov Identifier:	NCT00560235
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Ewing's sarcoma
Sarcoma, Ewing's
Ewing's family of tumors
Malignant mesenchymal tumor

Sarcoma
Osteosarcoma
Osteogenic sarcoma
Soft tissue sarcomas

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on January 15, 2009