Clinical Trial: Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)

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

Official Title: A Phase I Multicenter, Dose Escalation Study of AMN107 in Combination With Imatinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant Gastrointestin

Brief Summary: This study is an open-label, multicenter, Phase I dose-escalation study of the combination of AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed to determine the Phase II dose of AMN107 and imatinib when administered together in patients with imatinib-resistant GIST, and to characterize the safety, tolerability and pharmacokinetic (PK) profile of this combination.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: To determine the MTD which will be the Phase II dose of AMN107 when given in combination with Imatinib. The MTD is defined to be the highest dose of AMN107 in combination with Imatinib given for at least 21 days in the first treatment cycle [ Time Frame: From day 1 cycle 1 until at least six subjects have been treated at the recommended dose level and observed for at least 21 days ]

MTD is defined to be the highest dose of AMN in combination with imatinib given for at least 21 days in the first treatment cycle


Original Primary Outcome:

Current Secondary Outcome:

  • To characterize safety and tolerability of AMN107 in combination with Imatinib in GIST [ Time Frame: From day 1 cycle to the study completion visit ]
  • patients showing progression of disease on Imatinib. The patient will be followed-up for at least 4 cycles (28 days for one cycle) [ Time Frame: up to 4 cycles after disease profression on imatinib ]
    cycle = 28 days


Original Secondary Outcome:

Information By: Novartis

Dates:
Date Received: August 23, 2005
Date Started: August 2005
Date Completion:
Last Updated: May 9, 2013
Last Verified: May 2013