A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma

Completed · Phase 2

Conditions studied: Malignant Melanoma

In brief

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.

Key facts

Study ID

NCT00949702

Run by

Hoffmann-La Roche

People needed

132

Starts

2009-09-30

Expected to finish

2014-06-03

Last updated by the study team

2017-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA - School of Medicine; Division of Hematology/Oncology — Los Angeles, California, United States
• University of Colorado — Denver, Colorado, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Massachusetts General Hospital;Hematology/ Oncology — Boston, Massachusetts, United States
• Dana Farber Cancer Inst. ; Dept. of Medical Oncology — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• New York University Medical Center — New York, New York, United States
• Hospital of the Uni of Pennsylvania; Section of Hematology/Oncology — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Vanderbilt-Ingram Cancer Ctr — Nashville, Tennessee, United States
• Texas Oncology-Baylor Sammons Cancer Center — Dallas, Texas, United States
• University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
• Calvary Mater Newcastle; Melanoma Clinic — Newcastle, New South Wales, Australia
• Westmead Hospital; Medical Oncology and Pallative Care — Westmead, New South Wales, Australia
• Peter Maccallum Cancer Institute; Medical Oncology — Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

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