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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00474760

First received: May 16, 2007

Last updated: December 19, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 16, 2007

Last Updated Date

December 19, 2012

Start Date ^ICMJE

August 2005

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Safety and tolerability of CP-751,871

Change History

Complete list of historical versions of study NCT00474760 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pharmacokinetics [ Time Frame: approximately 76 months ] [ Designated as safety issue: No ]
Pharmacodynamics [ Time Frame: approximately 18 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Pharmacokinetics, pharmacodynamics and efficacy of CP-751,871

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Sarcoma, Ewing's

Intervention ^ICMJE

Drug: CP-751,871

Currently dosing at 20 mg/kg, IV on day 1 of each 28 day cycle until progression or unacceptable toxicity

Study Arm (s)

Experimental: 1

Intervention: Drug: CP-751,871

Publications *

Asmane I, Watkin E, Alberti L, Duc A, Marec-Berard P, Ray-Coquard I, Cassier P, Decouvelaere AV, Ranchère D, Kurtz JE, Bergerat JP, Blay JY. Insulin-like growth factor type 1 receptor (IGF-1R) exclusive nuclear staining: a predictive biomarker for IGF-1R monoclonal antibody (Ab) therapy in sarcomas. Eur J Cancer. 2012 Nov;48(16):3027-35. doi: 10.1016/j.ejca.2012.05.009. Epub 2012 Jun 7.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2012

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of Ewing's sarcoma family tumors

Exclusion Criteria:

Concurrent treatment with any other anti tumor agents

Gender

Both

Ages

9 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00474760

Other Study ID Numbers ^ICMJE

A4021010

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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