Patients who are on nilotinib treatment in a Novartis-sponsored, Oncology Global Development & Global Medical Affairs study and are benefiting from the treatment as judged by the investigator. All objectives of the parent study must have been reached, and the parent study must be in the process of being completed and reported. MedDRA version: 20.0 Level: LLT Classification code 10062427 Term: Gastrointestinal stromal tumor System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Class
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is currently enrolled in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs study receiving nilotinib and has fulfilled all their requirements in the parent study. 2. Patient is currently benefiting from the treatment with nilotinib, as determined by the investigator. 3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements. 4. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures. 5. Written informed consent obtained prior to enrolling in roll-over study. Other inclusion criteria as defined in the protocol apply. Are the trial subjects under 18? yes Number of subjects for this age range: 9 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 46 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: 1. 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. 2. Patient has participated in a Novartis sponsored combination trial where nilotinib was dispensed in combination with another study medication and patient is still receiving combination therapy. 3. Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval or inducing Torsade de Pointes and the treatment cannot be either safely discontinued at least one week prior to nilotinib treatment or switched to a different medication prior to start of nilotinib treatment and for the duration of the study. 4. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcG laboratory test. 5. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study and for 30 days after the final dose of nilotinib. Other exclusion criteria as defined in the protocol apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: throughout the study;Main Objective: To evaluate long term safety data (SAEs and AEs).;Secondary Objective: To evaluate clinical benefit as assessed by the investigator.;Primary end point(s): Frequency and severity of AEs/SAEs | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits;Timepoint(s) of evaluation of this end point: throughout the study | — |
Countries
Austria, Canada, France, Hong Kong, Hungary, Israel, Italy, Korea, Republic of, Netherlands, Singapore, Slovakia, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed