Clinical Trial VICCPHI1328

Title

A Phase 1b Open Label, Dose Escalation Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PLX3397 in Combination with Vemurafenib in V600-mutated BRAF Unresectable or Metastatic Melanoma

Principal Investigator(s)

Jeffrey Sosman

Details

  • Protocol No. VICCPHI1328
  • Open Date: 09/05/2013
  • Staging: Phase I
  • Age Group: Adults
  • Scope: National
  • Objective: The primary objective of the dose escalation phase of the study is to evaluate the safety and tolerability of PLX3397 and vemurafenib when administered in combination in order to determine the recommended Phase 2 dose (RP2D) for each component of the combination. The primary objective of the Extension cohort phase of the study is to assess the antitumor activity (response rate, response duration, PFS, and OS) of the agents when given in combination, as well as confirmation of safety. For both phases, the secondary objective is to characterize the PK of PLX3397 when administered in combination with vemurafenib. An exploratory objective is to measure the pharmacodynamic (PD) effects of the combined therapy in blood and paired biopsy tissue.
  • Disease Sites: Melanoma
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: PLX3397 (oral); PLX4032; RO5185426 (Vemurafenib); Vemurafenib
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01826448
  • Secondary Protocol No: PLX108-09

Description

Eligibility

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