A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma

• Status: Completed
• Trial end date: 2014-06-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Vemurafenib

Criteria

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