Clinical Trial VICCPHI0958


A Phase 1 Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of PLX3397 in Patients with Advanced, Incurable, Solid Tumors in which the Target Kinases Are Linked to Disease Pathophysiology

Principal Investigator(s)

Igor Puzanov


  • Protocol No. VICCPHI0958
  • Open Date: 02/05/2010
  • Staging: Phase I
  • Age Group: Adults
  • Scope: National
  • Objective: The primary objective for the dose escalation phase of this study is to evaluate the safety and PK of PLX3397 in patients with solid tumors. The primary objective for the Extension cohorts (to be enrolled under a subsequent protocol amendment) is to evaluate the objective tumor response (including overall response rate, duration of response, and progression free survival), safety, and PK of PLX3397 in patients with selected solid or hematologic tumors, depending on the safety, pharmacodynamic activity, and response data observed in the dose escalation phase.
  • Disease Sites: Phase I; GIST
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: PLX3397 (oral)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01004861
  • Secondary Protocol No: PLX108-01



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