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

Phase 2

Completed

• Conditions: Advanced Gastrointestinal Stromal Tumor
• Interventions: Drug: AMG 706

• Registration Number: NCT00254267
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-14
• Study First Submitted QC: 2005-11-14
• Study First Posted: 2005-11-16
• Primary Completion: 2007-02
• Study Completion: 2012-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-26
• Last Update Posted: 2014-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm One	AMG 706	AMG 706 125mg, oral, once a day

Primary Outcome Measures

Name	Time	Method
The objective response rate as assessed by modified RECIST	Every 8 weeks

Secondary Outcome Measures

Name	Time	Method
Duration of response, progression-free survival, time to response, overall survival, PK and safety profile	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;