Safety Study of PLX4032 in Patients With Solid Tumors

Status Completed

Clinical Trial 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 paired biopsy specimens obtained from patients with malignant melanoma who have the V600E BRAF oncogenic mutation.

Clinical Trial 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. PLX4032 is a compound that selectively inhibits oncogenic B-Raf kinase.

Two extension cohorts of patients with confirmed V600E mutations will be recruited, consisting of advanced melanoma and metastatic colorectal carcinoma. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00405587
Study type	Interventional
Source	Plexxikon
Contact
Status	Completed
Phase	Phase 1
Start date	November 2006
Completion date	February 2016

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