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

NCT02304809 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2025-08-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Vemurafenib

Vemurafenib is a low molecular weight, orally available, inhibitor of BRAF serine-threonine kinase. Mutations in the BRAF gene which substitute the valine at amino acid position 600 result in constitutively activated BRAF proteins, which can cause cell proliferation in the absence of growth factors that would normally be required for proliferation

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • Fondation ARC

    collaborator OTHER

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • Jean-Yves PI Blay, MD · CCLC LEON BERARD LYON

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-13
Primary Completion
2019-05-07
Completion
2027-10-13

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02304809 on ClinicalTrials.gov