TRIAL DETAIL

Phase 2 Study Assessing Secured Access to Vemurafenib for Patients With Tumors Harboring BRAF Genomic Alterations (AcSé)

Drug:
Trial Name:
Phase 2 Study Assessing Secured Access to Vemurafenib for Patients With Tumors Harboring BRAF Genomic Alterations (AcSé)
NCT#:
Conditions:
Solid Tumors
Status:
Active, not recruiting
Phase:
2
Start Date 07/01/2014
Age of Trial (yrs) 9.8
Treatment Phase:
Gleevec-resistant
Drug Category:
BRAF inhibitor
Strategy:
Block BRAF
Trial Type:
Specifically GIST plus other cancers
Other Protocol IDs:
UC-0105/1401 2014 001225 33
Sponsor:
UNICANCER
Patient Contact:
Céline Mahier + 33 1 44 23 55 84 c-mahier@unicancer.fr Marta Jimenez + 33 1.44.23.55.58 m-jimenez@unicancer.fr
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
Official Title: Secured Access to Vemurafenib for Patients With Tumors Harboring BRAF Genomic Alterations

Purpose: Patients with metastatic or unresectable locally advanced malignancies harboring BRAF genomic alterations, the biological target of vemurafenib, and who are no more amenable to curative treatment.

To explore the efficacy of vemurafenib as a single agent across diverse type of tumors guided by the presence of identified activating molecular alterations in the vemurafenib target gene, per cohort.

Trial Links

Trial Results

Drug Information
Plexxikon Announces FDA Approval of ZelborafTM (vemurafenib) and Companion Diagnostic for the Treatment of Patients with BRAF Mutation-Positive Metsatatic Melanoma
 
Zelboraf.com website Patient support, access to drug, etc.
 
Zelboraf prescribing information
 
Medical News Today story, Plexxikon Announces PLX4032 Phase 1 Data Showing Objective Responses In Metastatic Melanoma Patients
 
OncologySTAT article, Targeted Therapy PLX4032 Takes Center Stage in Metastatic Melanoma
 
RAF inhibitor resistance is mediated by dimerization of aberrantly spliced BRAF(V600E)
 

Trial Sites

Name
Address
City
State
Zip
Country
Paris
France