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
Phase 2
20 Years
N/A
20 Years
N/A
Open (Enrolling)
Both
Advanced Gastrointestinal Stromal Tumor
Both
Advanced Gastrointestinal Stromal Tumor
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The objective response rate as assessed by modified RECIST
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
20050129
NCT ID:
NCT00254267
Start Date:
November 2005
Completion Date:
March 2008
Related Keywords:
- Advanced Gastrointestinal Stromal Tumor
- Gastrointestinal Stromal Tumor, Imatinib Mesylate Resistance, Phase2 study, AMG 706
- Gastrointestinal Stromal Tumors
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