NCT01307397

A Study of Vemurafenib in Participants With Metastatic Melanoma

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,219 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Vemurafenib	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.

Timeline

• Start date: 2011-03-01
• Primary completion: 2016-02-24
• Completion: 2016-02-24
• First posted: 2011-03-02
• Last updated: 2017-12-18
• Results posted: 2017-12-18

Locations

280 sites across 44 countries: Albania, 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