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

Phase 2

Completed

• Conditions: Gastrointestinal Stromal Tumors
• Interventions: Drug: nilotinib

• Registration Number: NCT01863745
• Lead Sponsor: Novartis Pharmaceuticals

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

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 who were benefiting from treatment with nilotinib.

There was no screening period for this study. At the enrolment visit the patient was consented to the study and eligible patients started their treatment with nilotinib.

Study Timeline

• Study First Submitted: 2013-05-23
• Study First Submitted QC: 2013-05-23
• Study First Posted: 2013-05-29
• Study Start: 2013-06-25
• Primary Completion: 2023-10-02
• Study Completion: 2023-10-02
• Status Verified: 2024-07
• Results First Submitted: 2024-07-26
• Results First Submitted QC: 2024-07-26
• Last Update Submitted: 2024-07-26
• Results First Posted: 2024-08-19
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patient is currently enrolled in a Novartis-sponsored, Clinical study receiving nilotinib and benefiting from the treatment with nilotinib, as determined by the investigator

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nilotinib	nilotinib	The starting dose of nilotinib was same as the last dose given in the parent nilotinib study. After this, the dose of nilotinib was based on the investigator's judgment. The total daily dose was up to 800 mg.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.	Number of participants with adverse events (AEs) (any AE regardless of seriousness), serious adverse events (SAEs), Fatal SAEs and treatment related AEs.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Chuo ku, Tokyo, Japan