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

First Received on November 14, 2005. Last Updated on December 20, 2007 History of Changes

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00254267

Purpose

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.

Condition	Intervention	Phase
Advanced Gastrointestinal Stromal Tumor	Drug: AMG 706	Phase II

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

Resource links provided by NLM:

Genetics Home Reference related topics: gastrointestinal stromal tumor

MedlinePlus related topics: Cancer

Drug Information available for: Imatinib Imatinib mesylate Motesanib

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

The objective response rate as assessed by modified RECIST

Secondary Outcome Measures:

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

Estimated Enrollment:	35
Study Start Date:	November 2005
Estimated Study Completion Date:	March 2008

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254267

Sponsors and Collaborators

Amgen

Investigators

Study Director:

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00254267 History of Changes
Other Study ID Numbers:	20050129
Study First Received:	November 14, 2005
Last Updated:	December 20, 2007
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Amgen:

Gastrointestinal Stromal Tumor, Imatinib Mesylate Resistance, Phase2 study, AMG 706

Additional relevant MeSH terms:

Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012