For Healthcare Professionals

A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma

clipboard-pencil

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.
user-3

Who can take part

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

INCLUSION 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

EXCLUSION CRITERIA

  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
pin location

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


Contition

Malignant Melanoma

Age (in years)

18 - 200

Phase

Phase 2

Participants needed

132

Est. Completion Date

Oct 2013

Treatment type

Interventional


Sponsor

Hoffmann-La Roche

ClinicalTrials.gov identifier

NCT00949702

Study number

NP22657

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.