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Phase I/IIa Study to Evaluate the Safety, PK, PD, and Preliminary Efficacy of PLX8394 in Patients With Advanced Cancers.

Colorectal Cancer Clinical Trial

Official title:
A Phase I/IIa Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of PLX8394 in Patients With Advanced, Unresectable Solid Tumors

Clinical Trial Summary

The study objective is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered PLX8394 in patients with advanced solid tumors. An additional objective is to identify a Recommended Phase 2 (RP2D) for further evaluation in the Extension Cohorts (Phase IIa portion). The study objective of the Extension Cohorts (PART 2 portion) is to assess the objective tumor response and the PK, PD, and safety of PLX8394 when the RP2D is used in patients with advanced BRAF-mutated cancers.

Clinical Trial Description

This is an open-label, multi-center Phase I/IIa two-part study with a sequential dose escalation part, followed by three parallel Extension cohorts (BRAF-mutated melanoma, BRAF-mutated non-melanoma solid tumors, and BRAF-mutated classical hairy cell leukemia). Up to approximately 42 patients may be enrolled in the dose escalation phase of the study, depending on the number of cohorts required, number of patients per cohort needed, and the need for replacement patients. Approximately 130 patients are planned to be enrolled in the BRAF-mutated tumor Extension cohorts, with the goal of enrolling approximately 50 patients with BRAF/MEK/ERK inhibitor-naïve melanoma, approximately 10-15 patients with BRAF/MEK/ERK inhibitor-pretreated melanoma, approximately 50 patients with non-melanoma solid tumors, and approximately 10-15 patients with hairy cell leukemia. The trial was intended to be a Phase 1/2 trial, but the trial never moved forward to Phase 2. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02012231
Study type Interventional
Source NovellusDx
Contact
Status Terminated
Phase Phase 1
Start date February 2014
Completion date June 2015
View Details
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