Status:
COMPLETED
Safety Study of PLX4032 in Patients With Solid Tumors
Lead Sponsor:
Plexxikon
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Malignant Melanoma
Colorectal Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objective of this FIH study is to assess the safety and pharmacokinetics of PLX4032 in patients with solid tumors. The secondary objective is to assess the pharmacodynamic activity in pair...
Detailed Description
Activating mutations of the BRAF gene have been observed in a variety of cancers, including 55-68% of malignant melanomas. In general, oncogenic mutations of BRAF correlate with a poor outcome. PLX403...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00405587
Start Date
November 1 2006
End Date
February 1 2016
Last Update
August 22 2017
Active Locations (7)
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1
University of California Los Angeles
Los Angeles, California, United States, 90095
2
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
4
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States, 37232