Dabrafenib and/or Trametinib Rollover Study
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals
About this trial
This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
dabrafenib
Drugdabrafenib is available in capsules (50mg and 75mg) taken twice a day
trametinib
Drugtrametinib is available in tablets (0.5mg, 2mg dose)
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: dabrafenib monotherapyExperimental treatment 1 intervention
Group B: trametinib monotherapyExperimental treatment 1 intervention
Group C: Combination therapy (dabrafenib & trametinib)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination
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.
Time frame
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.Secondary outcomes
1
Clinical Benefit Assessment by investigator
To evaluate clinical benefit as assessed by the Investigator
Time frame
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.Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Novartis Investigative SiteCompletedC1121ABE, Caba, Buenos Aires
Argentina
ArgentinaSponsors and contacts
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Source ClinicalTrials.gov