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A Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of PLX4032 in Patients With Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Malignant Melanoma, Colorectal Carcinoma

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Trial Information

A Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of PLX4032 in Patients With Solid Tumors

Inclusion Criteria:

- Solid tumors confirmed histologically whose tumors are refractory to standard
therapy, or for whom standard or curative therapy does not exist

- Patients from whom paired melanoma biopsies are planned must have a V600E+ BRAF
mutation confirmed prior to the administration of PLX4032

- Previous chemotherapy, immunotherapy, or radiation therapy must have been completed
at least 2 weeks prior to starting PLX4032 therapy, and all associated toxicity must
be resolved prior to administration of PLX4032

- Patients in the Extension cohorts (melanoma or adenocarcinoma of the colon or rectum)
must have both a V600E+ BRAF mutation and measurable disease (by RECIST V 1.0
criteria) prior to the administration of PLX4032. All patients enrolled must provide
archival or fresh melanoma tumor biopsy for confirmation of V600E+ BRAF mutation
status by TaqMan assay

- ECOG performance status 0 or 1

- Life expectancy ≥ 3 months

- Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

- Brain metastases that are progressing or have been documented to be stable for less
than 3 months, or for which systemic corticosteroids are required

- Investigational drug use within 28 days of the first dose of PLX4032

- Uncontrolled intercurrent illness

- Refractory nausea and vomiting, malabsorption, or significant bowel resection that
would preclude adequate absorption

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety: subject incidence of adverse events, first-cycle DLTs and clinically significant changes in vital signs, ECGs and clinical laboratory tests

Outcome Time Frame:

1 year

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2006

Completion Date:

Related Keywords:

  • Malignant Melanoma
  • Colorectal Carcinoma
  • Carcinoma
  • Colorectal Neoplasms
  • Melanoma



MD Anderson Cancer Center Houston, Texas  77030-4096
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of California Los Angeles Los Angeles, California  90095-6951
University of Pennsylvania Philadelphia, Pennsylvania  19104
Vanderbilt Ingram Cancer Center Nashville, Tennessee  37232