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
N/A
N/A
Both
Gastrointestinal Stromal Tumors
Trial Information
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
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Frequency and nature of adverse events
Outcome Description:
To collect and assess long-term safety of nilotinib in patients receiving nilotinib and are benefiting from treatment with nilotinib n a Novartis-sponsored Oncology study which had reached its objectives.
Outcome Time Frame:
5 years
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
CAMN107A1201
NCT ID:
NCT01863745
Start Date:
July 2013
Completion Date:
December 2018
Related Keywords:
- Gastrointestinal Stromal Tumors
- ggastrointestinal stromal tumors
- gastrointestinal,
- stromal,
- tumors,
- GIST,
- AMN107,
- nilotinib
- Gastrointestinal Stromal Tumors
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