CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,219 enrolled
Drug / intervention
Vemurafenibdrug
Likely dose
Vemurafenib 960 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01307397
NCT01307397Phase 3Completed
CompareCT.gov

An Open-Label, Multicenter Study to Assess the Safety of RO5185426 (Vemurafenib) in Patients With Metastatic Melanoma

Hoffmann-La Roche·interventional·Posted Mar 2, 2011·Updated Dec 18, 2017

In Brief

A Phase 3 clinical trial evaluating Vemurafenib for Malignant Melanoma. Completed, enrolled 3,219 participants across 280 sites in 44 countries.

Detailed Summary

This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer \[AJCC\]) metastatic melanoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Melanoma
CountriesAlbania, Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Colombia, Croatia, Czechia, Denmark, Ecuador, Estonia, Finland, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, North Macedonia, Norway, Peru, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2, 2011
Enrollment StartMar 1, 2011
Primary CompletionFeb 24, 2016
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 15.3 years ago

Interventions

Vemurafenibdrug

Participants will receive continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant's safety, death, or study termination by the Sponsor, whichever occurs first.