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

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

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:	December 2009
Estimated Primary Completion Date:	December 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

Locations

United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Pfizer Investigational Site
Rochester, Minnesota, United States, 55905
United Kingdom, Surrey
Pfizer Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4021010
Study First Received:	May 16, 2007
Last Updated:	April 11, 2009
ClinicalTrials.gov Identifier:	NCT00474760 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
Sarcoma, Ewing's

Sarcoma
Osteogenic Sarcoma
Osteosarcoma
Ewing's Sarcoma

Additional relevant MeSH terms:

Neoplasms, Connective and Soft Tissue
Neoplasms
Sarcoma, Ewing's
Neoplasms by Histologic Type

Neoplasms, Bone Tissue
Sarcoma
Osteosarcoma
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on May 07, 2009