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. 2018 Feb 6;2018(2):CD011123. doi: 10.1002/14651858.CD011123.pub2

NCT02416232.

Study name An open label non randomized access study of trametinib for patients with advanced unresectable (stage IIIc) or distant metastatic (stage IV) BRAF V600E/K mutation positive cutaneous melanoma.
Methods Phase III non‐RCT.
Participants Metastatic melanoma with brain metastasis.
Estimated enrolment: 250.
Interventions Single arm study: participants will receive trametinib 2 mg orally once daily and, where appropriate, in combination with dabrafenib 150 mg orally twice daily.
Outcomes Primary outcomes:
  • Frequency of adverse events (AE);

  • Proportion of the AEs;

  • Number of participants with serious adverse events (SAEs); and

  • Response rates to treatment

Starting date March 2015.
Contact information USA GSK Clinical Trials Call Center, GSKClinicalSupportHD@gsk.com
Notes