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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

Patients are asked to take part in this research study because they have a skin cancer (melanoma) with a specific mutation (V-600 mutated BRAF) that has spread to other parts of the body (metastatic) or cannot be treated by surgery (unresectable). The purpose of this study is to find the best and safest dose of PLX3397 when used in combination with Vemurafenib (Zelboraf) and how often it should be taken. This is an investigational drug, which means it is not approved by the Food and Drug Administration (FDA). Vemurafenib has been approved by the United States Food and Drug Administration (FDA)/European Medicines Agency (EMA) for the treatment of a specific category of unresectable or metastatic melanoma. We want to find out what effects, good and/or bad, it has on patients and their cancer. Previous research has demonstrated that PLX3397 helps make the Vemurafenib work against tumor growth when given for treatment of the type of cancer under investigation in this clinical trial. Plexxikon Inc. is the sponsor of this study. This means that Plexxikon is providing the experimental drug and financial support to the study center and study doctor to conduct the study.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Male or female ≥18 years old.
• Patients with histologically confirmed unresectable Stage III or Stage IV metastatic melanoma who have not been previously treated with a selective BRAF inhibitor.
• Presence of a BRAF V600 mutation in the tumor tissue using the cobas BRAF mutation assay or comparable standard of care methodology.
• Measurable disease per RECIST v. 1.1 criteria.
• ECOG performance status 0 or 1.
Exclusion Criteria:
• Radiation therapy within 14 days of C1D1.
• Investigational drug use within 28 days of C1D1.
• Patients with active CNS lesions are excluded (i.e., those with radiographically unstable, symptomatic lesions). However, patients treated with stereotactic therapy or surgery are eligible if they remain without evidence of disease progression in the brain for ≥3 weeks.