NCT03340506
Dabrafenib and/or Trametinib Rollover Study
Recruiting
PHASE4Ages 18+InterventionalTreatmentNovartis Pharmaceuticals
~100 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:dabrafenibtrametinib
At a glance
Recruiting sites
8 of 33 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination
Measured over Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.
Conditions
Where it's being run
33 sites across 19 statesGermany6
Spain6
France5
Arizona1
Maryland1
Ohio1
Texas1
Buenos Aires1
Study leadership
- Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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.
What this trial measures
- Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combinationBaseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.
Clinical and laboratory assessments should be completed based on the local standard of care and physician practice for routine safety monitoring. More frequent examinations may be performed at the Investigator's discretion if medically indicated. Any abnormalities considered clinically significant, induce clinical signs or symptoms, or require changes in treatment constitute an adverse event.