At a glance
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An Open Label, Multi-center Nilotinib Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Nilotinib Study and Are Judged by the Investigator to Benefit From Continued Nilotinib Treatment
In Brief
A Phase 2 clinical trial evaluating nilotinib for Gastrointestinal Stromal Tumors. Completed, enrolled 15 participants across 11 sites.
Detailed Summary
The purpose of this study is to collect and assess long-term safety of nilotinib in patients who are on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development \& Medical Affairs study and are benefiting from the treatment as judged by the investigator.
Study Details
Timeline
Interventions
Nilotinib was administered daily as hard gelatin capsules for oral use. The starting dose of nilotinib was same as the last dose given in the parent nilotinib study. After this, the dose of nilotinib was based on the investigator's judgment. The total daily dose was up to 800 mg.