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

Amgen

Status and phase: Completed; Phase 2

Conditions: Advanced Gastrointestinal Stromal Tumor

Treatments: Drug: AMG 706

Study type: Interventional

Funder types: Industry

Identifiers

NCT00254267

20050129

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Arm One

Experimental group

Description:

AMG 706 125mg, oral, once a day

Treatment:

Drug: AMG 706