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

This study has been completed.

Sponsor:

Collaborator:

Takeda Bio Development Center, Ltd

Information provided by (Responsible Party):

Amgen

ClinicalTrials.gov Identifier:

NCT00254267

First received: November 14, 2005

Last updated: February 26, 2014

Last verified: February 2014

History of Changes

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 2


Study Type:	Interventional
Study Design:	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

Genetic and Rare Diseases Information Center resources: Gastrointestinal Stromal Tumors

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

The objective response rate as assessed by modified RECIST [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of response, progression-free survival, time to response, overall survival, PK and safety profile [ Time Frame: imaging, every 8 weeks; survival, every 6 months; PK, Days 1,15, 29, 43, 57, every 2 weeks in week 9 to 16, and every 4 weeks thereafter; ] [ Designated as safety issue: Yes ]


Enrollment:	35
Study Start Date:	November 2005
Study Completion Date:	December 2012
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm One AMG 706 125mg, oral, once a day	Drug: AMG 706 AMG 706 125mg, oral, once a day

Eligibility


Ages Eligible for Study:	20 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators

Amgen

Takeda Bio Development Center, Ltd

Investigators


Study Director:	MD	Amgen

More Information

Additional Information:

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

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. doi: 10.1007/s00280-010-1431-9. Epub 2010 Sep 14.


Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT00254267 History of Changes
Other Study ID Numbers:	20050129
Study First Received:	November 14, 2005
Last Updated:	February 26, 2014
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 Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Imatinib Mesylate	Niacinamide Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016

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