Intermittent Vs Continuous Dosing of Dabrafenib and Trametinib

A Randomized Phase II Trial of Intermittent Versus Continuous Dosing of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAF V600E/K Mutant Melanoma

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Frankos, Marie; Ford, Elizabeth

    Trial Phone: 321.841.7303 ; 321.841.7413

  • IRB No: SWOG 1320

    Protocol Abbrev: SWOG 1320

    Principal Investigator: Sajeve Samuel Thomas, MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: S1320

    Treatment: Targeted Therapy

    Applicable Disease Sites: Melanoma

    Therapies Involved: dabrafenib and trametinib

    ClinicalTrials.gov ID: NCT02196181

  • Objective

    The primary objective of this study is to compare progression-free survival with
    intermittent dosing and continuous dosing of dabrafenib and trametinib among patients with metastatic BRAFV600E/K mutant melanoma.

  • Key Eligibility

    *Patients must have BRAF mutation-positive melanoma (i.e., V600E or
    V600K) as determined via Sanger sequencing or an FDA-approved
    BRAF mutation detection assay. BRAFV600 mutant status must be
    documented by a CLIA-certified laboratory *Patients must not have brain metastases unless brain metastases have been treated and patient is asymptomatic with no residual neurological dysfunction and has not received enzyme-reducing anti-epileptic drugs or corticosteroids for at least 7 days prior to registration.