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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00254267
First Posted: November 16, 2005
Last Update Posted: February 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Takeda Bio Development Center, Ltd
Information provided by (Responsible Party):
Amgen
November 14, 2005
November 16, 2005
February 27, 2014
November 2005
February 2007   (Final data collection date for primary outcome measure)
The objective response rate as assessed by modified RECIST [ Time Frame: Every 8 weeks ]
The objective response rate as assessed by modified RECIST
Complete list of historical versions of study NCT00254267 on ClinicalTrials.gov Archive Site
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; ]
Duration of response, progression-free survival, time to response, overall survival, PK and safety profile
Not Provided
Not Provided
 
Evaluate the Efficacy of AMG 706 to Treat Advanced Gastrointestinal Stromal Tumors
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
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Gastrointestinal Stromal Tumor
Drug: AMG 706
AMG 706 125mg, oral, once a day
Experimental: Arm One
AMG 706 125mg, oral, once a day
Intervention: Drug: AMG 706
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
December 2012
February 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Japan
 
NCT00254267
20050129
Yes
Not Provided
Not Provided
Amgen
Amgen
Takeda Bio Development Center, Ltd
Study Director: MD Amgen
Amgen
February 2014

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