Status:
COMPLETED
Nilotinib Roll-over Protocol for Patients in Novartis-sponsored Nilotinib Study and Benefiting From Nilotinib Treatment
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Gastrointestinal Stromal Tumors
Eligibility:
All Genders
18-84 years
Phase:
PHASE2
Brief 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 st...
Detailed Description
This was an open label, multi-center, phase II study to collect and assess long-term safety of nilotinib to patients treated in Novartis sponsored clinical studies (NCT00785785 and NCT00718562) and wh...
Eligibility Criteria
Inclusion
- Patient is currently enrolled in a Novartis-sponsored, Clinical study receiving nilotinib and benefiting from the treatment with nilotinib, as determined by the investigator
Exclusion
- 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.
Key Trial Info
Start Date :
June 25 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01863745
Start Date
June 25 2013
End Date
October 2 2023
Last Update
August 19 2024
Active Locations (11)
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1
Novartis Investigative Site
Nagoya, Aichi-ken, Japan, 464 8681
2
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277 8577
3
Novartis Investigative Site
Gifu, Gifu, Japan, 501-1194
4
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 060 8648