Dabrafenib and/or Trametinib Rollover Study

Condition(s) studied

Investigational drug(s) / intervention(s)

dabrafenib: dabrafenib is available in capsules (50mg and 75mg) taken twice a day

trametinib: trametinib is available in tablets (0.5mg, 2mg dose)

Study summary

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

Primary outcome measure(s)

• Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination — 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.
  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.

Trial sites (34)