Study to allow access to dabrafenib and/or trametinib for subjects that are benefiting from dabrafenib and/or trametinib treatment in a Novartis or GSK sponsored study
Phase 3
- Conditions
- Rare Cancers
- Registration Number
- JPRN-jRCT2031210131
- Lead Sponsor
- Suzuki Kazuyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2
Inclusion Criteria
Patient is currently receiving treatment with dabrafenib/trametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.
In the opinion of the Investigator would benefit from continued treatment.
Exclusion Criteria
Patient has been previously permanently discontinued from study treatment in the parent protocol.
Patient's indication is commercially available and reimbursed in the local country.
Patient currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to evaluate long-term safety as assessed by occurrence of AEs/SAEs
- Secondary Outcome Measures
Name Time Method