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A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers

NCT01524978 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2017-11-20

Study results available
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Summary

This open-label, multi-center study will assess the efficacy and safety of vemurafenib in participants with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom vemurafenib is deemed the best treatment option in the opinion of the investigator. Participants will receive twice daily oral doses of 960 mg vemurafenib until disease progression, unacceptable toxicity, or withdrawal of consent. The safety and efficacy of vemurafenib in combination with cetuximab in a subset of participants with colorectal cancer will also be assessed.

Conditions

  • Multiple Myeloma, Neoplasms

Interventions

DRUG

cetuximab

Escalating doses administered on Day 1 and then once weekly by intravenous infusion.

DRUG

vemurafenib

Escalating doses given orally twice a day starting on Day 2

DRUG

vemurafenib

960 mg vemurafenib orally twice a day until disease progression, unacceptable toxicity, or withdrawal of consent.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-12
Primary Completion
2016-10-28
Completion
2016-10-28
FDA Drug
Yes

Countries

  • United States
  • China
  • France
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT01524978 on ClinicalTrials.gov