Phase I/IIa Study to Evaluate the Safety, PK, PD, and Preliminary Efficacy of PLX8394 in Patients With Advanced Cancers.
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.
Non-small Cell Lung Cancer
Hairy Cell Leukemia
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/IIa Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of PLX8394 in Patients With Advanced, Unresectable Solid Tumors|
- Phase 1 dose escalation: Identification of Recommended Phase 2 Dose Safety of PLX8394 [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]Physical examinations, vital signs, 12-lead electrocardiograms, adverse events, hematology, serum chemistry, and urinalysis will be used to assess safety and tolerability.
- Identification of Recommended Phase 2 dose (RP2D) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Study drug administration is dosed continuously until clinically significant disease progression, discontinuation of study for any reason or one of the stopping criteria is met.
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Experimental: Dose Escalation
Cohort 1/Day -7 = 300 mg/day PLX8394; Cohort 1/Day 1 = 900 mg/day PLX8394
PLX8394 is a next-generation, orally available, small-molecule, selective inhibitor of BRAF.
Other Name: PLX8394
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02012231
|United States, Arizona|
|Scottsdale, Arizona, United States, 85258|
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|United States, Washington|
|Evergreen Hematology & Oncology|
|Spokane, Washington, United States, 99218|
|Principal Investigator:||Sunil Sharma, MD||Huntsman Cancer Institute|