Study for Patients Continuing Capmatinib Treatment from a Previous Novartis Trial
Sponsor: Novartis Pharmaceuticals
ClinicalTrials ID:NCT03040973
This study allows patients who were part of a previous Novartis trial to continue receiving capmatinib treatment, either alone or with other medications, if they are benefiting from it.
Patient Parameters
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Program Overview
The aim of this study is to ensure that patients who have been participating in a Novartis trial and are benefiting from capmatinib treatment can continue to receive it. This includes those taking capmatinib alone or with other treatments. The study will monitor the long-term safety of the treatment.
Description
This study is open to patients who have completed a previous Novartis trial and are still benefiting from capmatinib treatment. There is no screening period, and eligible patients can start treatment immediately after giving consent. Patients will visit the study center regularly to receive their medication and undergo safety checks. If a public health emergency occurs, alternative care methods may be used.
Patients will continue treatment until it is no longer beneficial, they experience unacceptable side effects, their disease progresses, they choose to stop, or the treatment becomes available through other means. If a combination treatment is stopped, patients may continue with capmatinib alone if it is still beneficial.
The study will last up to 10 years or until all patients no longer need the treatment or Novartis ends the program. Patients will be monitored for safety for 30 days after their last dose or until any serious side effects are resolved.
Eligibility Criteria
Inclusion Criteria
- Currently receiving capmatinib treatment in a Novartis trial, either alone or with other treatments.
- Benefiting from the treatment as determined by the doctor.
- Willing and able to attend scheduled visits and follow the treatment plan.
- Have given written consent to participate in the study.
Exclusion Criteria
- Not currently receiving treatment due to unresolved side effects.
- Pregnant or breastfeeding women.
- Women who can become pregnant must use effective birth control during treatment and for at least 7 days after stopping.
- Participating in another clinical study besides the parent study.
- Received live vaccines within 30 days before starting the study treatment.
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