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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Im

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 Summary:
Sponsor: Amgen

Current Primary Outcome: The objective response rate as assessed by modified RECIST [ Time Frame: Every 8 weeks ]

Original Primary Outcome: The objective response rate as assessed by modified RECIST

Current Secondary Outcome: 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; ]

Original Secondary Outcome: Duration of response, progression-free survival, time to response, overall survival, PK and safety profile

Information By: Amgen

Dates:
Date Received: November 14, 2005
Date Started: November 2005
Date Completion:
Last Updated: February 26, 2014
Last Verified: February 2014