Evaluate the Efficacy of AMG 706 to Treat Advanced Gastrointestinal Stromal Tumors

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2007 by Amgen.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Amgen

ClinicalTrials.gov Identifier:

NCT00254267

First received: November 14, 2005

Last updated: December 20, 2007

Last verified: December 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

November 14, 2005

Last Updated Date

December 20, 2007

Start Date ^ICMJE

November 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

The objective response rate as assessed by modified RECIST

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00254267 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Duration of response, progression-free survival, time to response, overall survival, PK and safety profile

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluate the Efficacy of AMG 706 to Treat Advanced Gastrointestinal Stromal Tumors

Official Title ^ICMJE

An Open-Label Phase 2 Study of AMG 706 in Japanese Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs) Who Developed Progressive Disease or Relapsed While on Imatinib Mesylate

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of AMG 706 in patients with gastrointestinal stromal tumor that have not been controlled while taking imatinib mesylate.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Advanced Gastrointestinal Stromal Tumor

Intervention ^ICMJE

Drug: AMG 706

Study Arm (s)

Not Provided

Publications *

Benjamin RS, Schöffski P, Hartmann JT, Van Oosterom A, Bui BN, Duyster J, Schuetze S, Blay JY, Reichardt P, Rosen LS, Skubitz K, McCoy S, Sun YN, Stepan DE, Baker L. Efficacy and safety of motesanib, an oral inhibitor of VEGF, PDGF, and Kit receptors, in patients with imatinib-resistant gastrointestinal stromal tumors. Cancer Chemother Pharmacol. 2011 Jul;68(1):69-77. Epub 2010 Sep 14.

* 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

Active, not recruiting

Enrollment ^ICMJE

Completion Date

March 2008

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of histological confirmed GIST
Had prior imatinib mesylate therapy
Has at least 1 measurable leasion by modified RECIST

Exclusion Criteria:

Central nervous system tumor involvement requiring treatment
History of myocardial infraction
Uncontrolled hypertension

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00254267

Other Study ID Numbers ^ICMJE

20050129

Has Data Monitoring Committee

Not Provided

Responsible Party

Global Development Leader, Amgen Inc.

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

December 2007

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

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