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

Amgen35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Gastrointestinal Stromal Tumor

Interventions

AMG 706DRUG

AMG 706 125mg, oral, once a day

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The objective response rate as assessed by modified RECIST

Time frame: Every 8 weeks

Secondary Outcomes

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;

Data from ClinicalTrials.gov

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