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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT01863745

Collaborator

(none)

Enrollment

Locations

Arm

123.3

Anticipated Duration (Months)

1.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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 CD&MA study and are benefiting from the treatment as judged by the investigator.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Stromal Tumors	Drug: nilotinib	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 25, 2013

Anticipated Primary Completion Date :

Oct 4, 2023

Anticipated Study Completion Date :

Oct 4, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: nilotinib 16 patients who are currently enrolled in a Novartis- sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study receiving nilotinib and has fulfilled all their requirements in the parent study will be enrolled.	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.

Arm

Intervention/Treatment

Experimental: nilotinib

16 patients who are currently enrolled in a Novartis- sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study receiving nilotinib and has fulfilled all their requirements in the parent study will be enrolled.

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.

Outcome Measures

Primary Outcome Measures

Frequency and nature of adverse events [5 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Nagoya	Aichi	Japan	464 8681
2	Novartis Investigative Site	Kashiwa	Chiba	Japan	277 8577
3	Novartis Investigative Site	Gifu-city	Gifu	Japan	501-1194
4	Novartis Investigative Site	Sapporo city	Hokkaido	Japan	060 8648
5	Novartis Investigative Site	Yokohama-city	Kanagawa	Japan	241-8515
6	Novartis Investigative Site	Kumamoto City	Kumamoto	Japan	860-8556
7	Novartis Investigative Site	Sendai city	Miyagi	Japan	980 8574
8	Novartis Investigative Site	Kurashiki	Okayama	Japan	701-0192
9	Novartis Investigative Site	Osaka-city	Osaka	Japan	540-0006
10	Novartis Investigative Site	Suita city	Osaka	Japan	565 0871
11	Novartis Investigative Site	Chuo ku	Tokyo	Japan	104 0045