Melanoma Clinical Trial

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A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma

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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.

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Eligibility 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

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

132

Study ID:

NCT00949702

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 15 Locations for this study

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UCLA - School of Medicine; Division of Hematology/Oncology
Los Angeles California, 90095, United States
University of Colorado
Denver Colorado, 80262, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Massachusetts General Hospital;Hematology/ Oncology
Boston Massachusetts, 02114, United States
Dana Farber Cancer Inst. ; Dept. of Medical Oncology
Boston Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
New York University Medical Center
New York New York, 10036, United States
Hospital of the Uni of Pennsylvania; Section of Hematology/Oncology
Philadelphia Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh Pennsylvania, 15213, United States
Vanderbilt-Ingram Cancer Ctr
Nashville Tennessee, 37232, United States
Texas Oncology-Baylor Sammons Cancer Center
Dallas Texas, 75246, United States
University of Texas M.D. Anderson Cancer Center
Houston Texas, 77030, United States
Calvary Mater Newcastle; Melanoma Clinic
Newcastle New South Wales, 2298, Australia
Westmead Hospital; Medical Oncology and Pallative Care
Westmead New South Wales, 2145, Australia
Peter Maccallum Cancer Institute; Medical Oncology
Melbourne Victoria, 3000, Australia
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How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

132

Study ID:

NCT00949702

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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