Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00405587
Status:
COMPLETED
Last Update Posted:
2017-08-22
First Post:
2006-11-28
Brief Title:
Safety Study of PLX4032 in Patients With Solid Tumors
Sponsor:
Plexxikon
Organization:
Plexxikon
Study Overview
Official Title:
A Study to Assess Safety Pharmacokinetics and Pharmacodynamics of PLX4032 in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2016-10
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 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
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 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
Two extension cohorts of patients with confirmed V600E mutations will be recruited consisting of advanced melanoma and metastatic colorectal carcinoma
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