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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
Open (Enrolling)
Both
Advanced Gastrointestinal Stromal Tumor

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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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