Nilotinib Roll-over Protocol for Patients in Novartis-sponsored Nilotinib Study and Benefiting From Nilotinib Treatment

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

ClinicalTrials.gov Identifier: NCT01863745

Novartis Reference Number: CAMN107A1201

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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. 

Study Description

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.

Condition 
Gastrointestinal Stromal Tumors
Phase 
Phase 2
Overall status 
Active, not recruiting
Enrollment count 
15 participants
Start date 
Jun 25, 2013
Completion date 
Oct 04, 2023
Gender 
All
Age(s)
(Child, Adult, Older Adult)

Interventions

Drug
nilotinib
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.

Eligibility Criteria

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.

Study Locations

Japan
Novartis Investigative Site
-
Nagoya, 464 8681
Aichi
Japan
Novartis Investigative Site
-
Kashiwa, 277 8577
Chiba
Japan
Novartis Investigative Site
-
Gifu-city, 501-1194
Gifu
Japan
Novartis Investigative Site
-
Sapporo city, 060 8648
Hokkaido
Japan
Novartis Investigative Site
-
Yokohama-city, 241-8515
Kanagawa
Japan
Novartis Investigative Site
-
Kumamoto City, 860-8556
Kumamoto
Japan
Novartis Investigative Site
-
Sendai city, 980 8574
Miyagi
Japan
Novartis Investigative Site
-
Kurashiki, 701-0192
Okayama
Japan
Novartis Investigative Site
-
Osaka-city, 540-0006
Osaka
Japan
Novartis Investigative Site
-
Suita city, 565 0871
Osaka
Japan
Novartis Investigative Site
-
Chuo ku, 104 0045
Tokyo
Japan

Have a question?

Call 1-999-669-6682 or email [email protected]