For Healthcare Professionals

A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma


About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


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


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

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Malignant Melanoma

Age (in years)

18 - 200


Phase 2

Participants needed


Est. Completion Date

Oct 2013

Treatment type



Hoffmann-La Roche identifier


Study number


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