Study Of Anti-IGF-IR CP-751,871 In Patients With Solid Tumors - Full Text View

Purpose

This is a phase 1 study of anti-IGF-IR CP-751,871 in patients with solid tumors currently enrolling patients 9 years old and older with Ewing's sarcoma family of tumors (Ewing's, PNET and Askin's).

Condition	Intervention	Phase
Sarcoma, Ewing's	Drug: CP-751,871	Phase I

MedlinePlus related topics:

Cancer Soft Tissue Sarcoma

U.S. FDA Resources

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

Official Title:	Phase 1, Open Label, Multiple Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of CP 751,871 In Patients With Advanced Solid Tumors

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety and tolerability of CP-751,871 [ Time Frame: approximately 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetics [ Time Frame: approximately 36 months ] [ Designated as safety issue: No ]
Pharmacodynamics [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	65
Study Start Date:	August 2005
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: CP-751,871 Currently dosing at 20 mg/kg, IV on day 1 of each 28 day cycle until progression or unacceptable toxicity

Eligibility

Ages Eligible for Study:	9 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Ewing's sarcoma family tumors

Exclusion Criteria:

Concurrent treatment with any other anti tumor agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474760

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

Locations


United States, Michigan
	Pfizer Investigational Site	Active, not recruiting
	Ann Arbor, Michigan, United States, 48109

United States, Minnesota
	Pfizer Investigational Site	Recruiting
	Rochester, Minnesota, United States, 55905

United Kingdom, Surrey
	Pfizer Investigational Site	Active, not recruiting
	Sutton, Surrey, United Kingdom, SM2 5PT

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4021010
First Received:	May 16, 2007
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00474760
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

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 October 10, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00474760