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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.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 29 Aug 2023

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At a glance

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

    • 17 May 2018 Status changed from active, no longer recruiting to completed.
    • 25 Oct 2017 Planned End Date changed from 1 Apr 2018 to 30 Apr 2018.
    • 09 Oct 2017 Results from 5-year analysis (data cut off October 13, 2016 n=162) published in the Journal of Clinical Oncology.
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