Clinical Trial VICCPHI1333

Title

A Phase I Dose Escalation Open-Label Safety, Pharmacokinetic and Pharmacodynamic Study to Determine the Recommended Phase II Dose of GSK1120212 Dosed in Combination with GSK2141795

Principal Investigator(s)

Julie Means-Powell

Details

  • Protocol No. VICCPHI1333
  • Open Date: 09/18/2013
  • Staging: Phase I
  • Age Group: Adults
  • Scope: National
  • Objective: Part1A: To determine the safety, tolerability and recommended Phase II dose of GSK1120212 and GSK2141795 administered in combination orally, once daily continuously. Part1B: To determine the safety, tolerability and recommended Phase II dose of GSK1120212 and GSK2141795 administered in combination with an alternate schedule (i.e., at least one agent is dosed intermittently) Part2A, Part2B: To evaluate the clinical activity of GSK1120212 and GSK2141795 administered in combination in subjects with solid tumors that are predicted to be sensitive to the inhibition of MEK and/or AKT, including TNBC and BRAF-wild type melanoma.
  • Disease Sites: Breast; Melanoma
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: GSK1120212; GSK2141795
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01138085
  • Secondary Protocol No: TAC113886

Description

Eligibility

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