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

Sponsor:	Pfizer
Information provided by (Responsible Party):	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety and tolerability of CP-751,871 [ Time Frame: approximately 76 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetics [ Time Frame: approximately 76 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 2012
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	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, 48109-0848
United States, Minnesota
Pfizer Investigational Site
Rochester, Minnesota, United States, 55905
United Kingdom
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
ClinicalTrials.gov Identifier:	NCT00474760 History of Changes
Other Study ID Numbers:	A4021010
Study First Received:	May 16, 2007
Last Updated:	February 16, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Sarcoma, Ewing's
Sarcoma
Osteosarcoma
Neoplasms, Bone Tissue

Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on February 21, 2012