Ignite Creation Date:
2024-05-06 @ 2:18 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02012231
Status:
TERMINATED
Last Update Posted:
2020-10-19
First Post:
2013-12-05
Brief Title:
Phase IIIa Study to Evaluate the Safety PK PD and Preliminary Efficacy of PLX8394 in Patients With Advanced Cancers
Sponsor:
Fore Biotherapeutics
Organization:
Fore Biotherapeutics
Study Overview
Official Title:
A Phase IIIa Study to Assess the Safety Pharmacokinetics and Pharmacodynamics of PLX8394 in Patients With Advanced Unresectable Solid Tumors
Status:
TERMINATED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
This is an open-label multi-center Phase IIIa 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 BRAFMEKERK inhibitor-naïve melanoma approximately 10-15 patients with BRAFMEKERK 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 12 trial but the trial never moved forward to Phase 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None