CLINICAL TRIAL SUMMARY

MDACC Study No:2012-0437 (clinicaltrials.gov NCT No: NCT01667419)
Title:A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Vemurafenib (RO5185426) Adjuvant Therapy in Patients with Surgically Resected, Cutaneous BRAF-Mutant Melanoma at High Risk for Recurrence
Principal Investigator:Kevin B. Kim
Treatment Agent:Vemurafenib
Study Status:Closed
Study Description:The goal of this clinical research study is to learn if vemurafenib is
effective in preventing melanoma from coming back in patients who have the BRAF
mutation. The safety of vemurafenib will also be studied.

In this study, some patients will receive vemurafenib and some patients will
receive a placebo.

Vemurafenib is designed to block the BRAF gene mutation. This mutation causes
cancer and cancer growth. By blocking this mutation, the drug may kill the
cancer cells with the mutation and/or stop the tumor from growing.

A placebo is not a drug. It looks like the study drug but is not designed to
treat any disease or illness. It is designed to be compared with a study drug
to learn if the study drug has any real effect.

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Disease Group:Melanoma
Phase of Study:Phase III
Treatment Agents:Vemurafenib
Treatment Location:Both at MDACC & and Other Sites
Estimated Length of Stay in Houston:
Supported By:F. Hoffman LaRoche Ltd.
Return Visit:
Home Care:


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Kevin B. Kim
Dept:Melanoma Medical Oncology
For Clinical Trial Enrollment:713-792-2921
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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