An Open-Label, Dose-Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the BRAF Inhibitor GSK2118436 in Combination with the MEK Inhibitor GSK1120212 in Subjects with BRAF Mutant Metastatic Melanoma.

Trial Profile

An Open-Label, Dose-Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the BRAF Inhibitor GSK2118436 in Combination with the MEK Inhibitor GSK1120212 in Subjects with BRAF Mutant Metastatic Melanoma.

Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 09 Oct 2017

At a glance

  • Drugs Dabrafenib (Primary) ; Trametinib (Primary)
  • Indications Colorectal cancer; Malignant melanoma
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 09 Oct 2017 Results from 5-year analysis (data cut off October 13, 2016 n=162) published in the Journal of Clinical Oncology.
    • 10 Jun 2017 Biomarkers information updated
    • 06 Jun 2017 Five-year overall survival (OS) update phase II results (dabrafenib (D) and dabrafenib (D) +trametinib (T) arms ; n=54 each, data cut off : 13 Oct 2016) presented at the 53rd Annual Meeting of the American Society of Clinical Oncology
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