Evaluate the Efficacy of AMG 706 to Treat Advanced Gastrointestinal Stromal Tumors
![]() |
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. |
ClinicalTrials.gov Identifier: NCT00254267 |
Recruitment Status
:
Completed
First Posted
: November 16, 2005
Last Update Posted
: February 27, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Gastrointestinal Stromal Tumor | Drug: AMG 706 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 35 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | November 2005 |
Actual Primary Completion Date : | February 2007 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm One
AMG 706 125mg, oral, once a day
|
Drug: AMG 706
AMG 706 125mg, oral, once a day
|
- The objective response rate as assessed by modified RECIST [ Time Frame: Every 8 weeks ]
- 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; ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00254267
Study Director: | MD | Amgen |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT00254267 History of Changes |
Other Study ID Numbers: |
20050129 |
First Posted: | November 16, 2005 Key Record Dates |
Last Update Posted: | February 27, 2014 |
Last Verified: | February 2014 |
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 |