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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, United States
Novartis Investigative Site
Lyon, France
Novartis Investigative Site
Berlin, Germany
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
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
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
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)
cycle = 28 days
Time frame: up to 4 cycles after disease profression on imatinib
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Novartis Investigative Site
Milan, MI, Italy