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
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
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 CD&MA study and are benefiting from the treatment as judged by the investigator.
Gastrointestinal Stromal Tumors
Active, not recruiting
Jul 17, 2020
Jun 25, 2013
Oct 04, 2023
(Child, Adult, Older Adult)
Nilotinib can be provided as 200 mg and 150 mg hard gelatin capsules. The starting dose of nilotinib should be the same as the last dose that was given in the parent nilotinib study. After this, the dose of nilotinib is based on the investigator's judgment.
Patient is currently enrolled in a Novartis-sponsored, Oncology CD&MA study receiving nilotinib and benefiting from the treatment with nilotinib, as determined by the investigator.
Patient has been permanently discontinued from nilotinib treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason.
Other protocol-defined inclusion/exclusion criteria may apply.