To provide study drug to patients that benefit from treatment judged by the investigator - to obtain additional long-term safety and efficacy data of this combination regimen in GIST
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Nilotinib 50 mg and 200 mg gelatin capsules and Imatinib 100 mg and 400 mg film-coated tablets in bottles.. Medication labels for each study drug complied with the legal requirements of each country, were printed in the local language.
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Novartis Investigative Site
Lyon, France
Novartis Investigative Site
Milan, MI, Italy
Safety and tolerability of nilotinib either as single agent or in combination with Imatinib
Assessed by AE evaluation, including safety laboratory and cardiac safety (ECG, cardiac enzymes, ECHO) measures.
Time frame: AE monitored continuously from day 1 cycle 1 to the study completion visit; safety laboratory and cardiac safety monitored every 3 treatment cycles (every 3 months) from day 1 cycle 1 to the study completion visit
To assess any clinical responses in Imatinib-resistant GIST patients. Assessment of tumor response will be made based on modified RECIST criteria - to be assessed at the end of every cycle of treatment
Assessment of tumor response will be made based on modified RECIST criteria.
Time frame: every 3 months, at completion of every third treatment cycle prior to first dose of next cycle, at study completion visit
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