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December 18, 2012Journal of Clinical Oncology479 citationsOpen Access

Phase II Study of Trametinib in BRAF-Mutant Melanoma Treatment

Phase II Study of the MEK1/MEK2 Inhibitor Trametinib in Patients With Metastatic BRAF -Mutant Cutaneous Melanoma Previously Treated With or Without a BRAF Inhibitor

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Authors

KKKevin B. KimRKRichard KeffordAPAnna C. Pavlick

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Overview

Randomized trial evaluates trametinib's effectiveness in BRAF-inhibitor naive melanoma, suggesting clinical activity in this population.

Key Points

  • To determine the response rate of trametinib in patients with metastatic BRAF-mutant melanoma.
  • Open-label, two-stage, phase II study
  • Cohort A: patients previously treated with a BRAF inhibitor; Cohort B: BRAF-inhibitor naive
  • Patients received 2 mg of trametinib orally once daily.
  • Cohort A (n=40) showed no confirmed responses; 28% stable disease, median progression-free survival (PFS) 1.8 months.
  • Cohort B (n=57) had 1 complete response (2%) and 13 partial responses (23%), confirmed RR 25%, median PFS 4.0 months.
  • Frequent adverse events included skin toxicity, nausea, edema, diarrhea, pruritis, and fatigue.

Cite This Study

Kim et al. (2012) studied this question.

synapsesocial.com/papers/6a0c691f106bfae8518869efhttps://doi.org/10.1200/jco.2012.43.5966
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