NCT00949702

A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma

An Open-label Multicenter Study on the Efficacy of Continuous Oral Dosing of Vemurafenib on Tumour Response in Previously Treated Patients With Metastatic Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label single arm study will assess the efficacy, safety and tolerability of Vemurafenib in previously treated patients with metastatic melanoma. Patients will receive oral Vemurafenib \[RG7204; PLEXXIKON: PLX4032\] at a dose of 960 mg b.i.d. continuously until disease progression or withdrawal from study and will be assessed at regular intervals for tumour response and tolerability. Target sample size is \<100 patients.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	vemurafenib	960 mg b.i.d. continuous oral dosing

Timeline

• Start date: 2009-09-30
• Primary completion: 2010-09-27
• Completion: 2014-06-03
• First posted: 2009-07-30
• Last updated: 2017-07-25
• Results posted: 2011-12-22

Locations

15 sites across 2 countries: United States, Australia