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
Qualifiers
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
Treatments tested in this trial
- dabrafenib
- trametinib
Treatment groups
100 Participants
are divided into 3 treatment groupsLocations
31Argentina
Novartis Investigative SiteC1121ABE, CabaBuenos Aires, Argentina
Austria
Novartis Investigative Site6020, InnsbruckTyrol, Austria
China
Novartis Investigative Site100036, Beijing China
Denmark
Novartis Investigative SiteDK-2100, Copenhagen Denmark
Sponsors and collaborators
Novartis Pharmaceuticals
Lead sponsor
Source ClinicalTrials.gov