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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.

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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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