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

Novartis Pharmaceuticals15 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastrointestinal Stromal Tumors

Interventions

nilotinibDRUG

Nilotinib was administered daily as hard gelatin capsules for oral use. 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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 84 Years

Medical Language ↔ Plain English

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 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.

Locations (11)

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Kashiwa, Chiba, Japan

Novartis Investigative Site

Gifu, Gifu, Japan

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of participants with adverse events (AEs) (any AE regardless of seriousness), serious adverse events (SAEs), Fatal SAEs and treatment related AEs.

Time frame: Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.

Data from ClinicalTrials.gov

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