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

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.

Inclusion Criteria:

• adult patients >/=18 years of age
• histologically confirmed metastatic melanoma (Stage IV, AJCC)
• patients must have completed and failed at least one prior standard of care regimen (e.g. DTIC, temozolomide, etc.)
• BRAF V600E positive mutation (by Roche CoDx BRAF mutation assay)
• measurable disease by RECIST criteria
• negative pregnancy test and, for fertile men and women, effective contraception during treatment and for 6 months after completion

Exclusion Criteria:

• active CNS metastases on CT/MRI within 28 days prior to enrollment
• history of or known carcinomatous meningitis
• previous treatment with BRAF (sorafenib allowed) or MEK inhibitor
• cardiac dysrhythmias >2 NCI CTCAE or treatment with drugs with dysrhythmic potential
• uncontrolled hypertension(>150/100mmHg) despite optimal medical therapy
• infectious disease including HIV, HBV and HCV