Study to allow access to imatinib for patients who are on imatinib treatment in a Novartis-sponsored study and are benefiting from the treatment as judged by the investigator.
- Conditions
- Male and female patients who are currently enrolled in a Novartissponsored, Oncology OGD&GMA imatinib study, are benefiting from treatment with imatinib and have fulfilled all their requirements in the parent study.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-002540-25-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 200
Patient is currently enrolled in a Novartis- sponsored, Oncology Global Development & Global Medical Affairs study receiving imatinib and has
fulfilled all their requirements in the parent study.
Patient is currently benefiting from the treatment with imatinib, as determined by the investigator.
Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Patient has been permanently discontinued from imatinib study treatment in the
parent study due to unacceptable toxicity, non-compliance to study procedures,
withdrawal of consent or any other reason.
Patient has participated in a Novartis sponsored combination trial where imatinib
was dispensed in combination with another study medication and is still receiving
combination therapy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method