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Clinical Trial Detail

An Extension (Rollover) Study of Vemurafenib in Patients With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol

Complete title: An Open-Label, Extension (Rollover) Study Of Vemurafenib in Patients with BRAFV600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol.

Research Study Number 20132215
Principal Investigator John Thompson, MD
Phase III

Research Study Description

This open-label, multicenter, non-randomized study will provide continued access to vemurafenib for eligible patients with BRAF V600 mutation-positive malignancy, who were previously enrolled and treated in an antecedent vemurafenib protocol and did not meet the protocol's criteria for disease progression, or are treated beyond progression and are still deriving clinical benefit (as assessed by investigator), and may therefore potentially benefit from continued treatment with vemurafenib. Patients will receive treatment with vemurafenib 960 mg orally twice daily or, if the dose was reduced in an antecedent protocol, the dose of the last visit of the antecedent study (minimum 480 mg orally twice daily). Treatment will continue until progression of disease or as long as the patient is deriving clinical benefit, as judged by the investigator, or until unacceptable toxicity occurs.

Eligibility Criteria (must meet the following to participate in this study)

** For Eligibility information, please click on the "Look up trial at NIH" link above. **

Other eligibility criteria may apply.

Research Study Number 20132215
Contact Seattle Cancer Care Alliance Intake Office
Telephone 800-804-8824 / 206-606-1024

Keywords: Hematologic Malignancies; Lymphoproliferative Disorders; Multiple Myeloma (MM); Solid Tumors; Neoplasms; Immunoproliferative Disorders

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