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

Gastrointestinal Stromal Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01863745
• Other study ID #: CAMN107A1201
• Status: Completed
• Phase: Phase 2
• Start date: June 25, 2013
• Est. completion date: October 2, 2023

Study information

• Verified date: October 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2, 2023
• Est. primary completion date: October 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

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.

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Chuo ku	Tokyo
Japan	Novartis Investigative Site	Gifu-city	Gifu
Japan	Novartis Investigative Site	Kashiwa	Chiba
Japan	Novartis Investigative Site	Kumamoto City	Kumamoto
Japan	Novartis Investigative Site	Kurashiki	Okayama
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Sapporo city	Hokkaido
Japan	Novartis Investigative Site	Sendai city	Miyagi
Japan	Novartis Investigative Site	Suita	Osaka
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events	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.	10 years