Clinical Trial VICCMELP1325

Title

A Phase IB/II, Multicenter, Study of LEE011 in Combination with LGX818 in Adult Patients with BRAF mutant melanoma

Principal Investigator(s)

Jeffrey Sosman

Details

  • Protocol No. VICCMELP1325
  • Open Date: 09/25/2013
  • Staging: Phase I/II
  • Age Group: Adults
  • Scope: National
  • Objective: Phase Ib: To estimate the MTD(s) and/or determine the RP2D of oral LEE011 in combination with oral LGX818 in patients with BRAF mutant melanoma. Phase II, Part 1: To assess the anti-tumor activity of LEE011 in combination with LGX818 vs. LGX818 alone in patients with metastatic BRAF mutant melanoma who are naive to poor selective BRAFi treatment. Phase II, Part 2: To assess the anti-tumor activity of LEE011 in combination with LGX818 in patients with metastatic BRAF mutant melanoma who are resistant to prior selective BRAFi treatment
  • Disease Sites: Melanoma
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: LEE011; LGX818
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01777776
  • Secondary Protocol No: CLEE011X2105

Description

Eligibility

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