This open-label study will assess the efficacy and safety of vemurafenib (RO5185426) in metastatic melanoma patients with untreated or treated brain metastases. Patients will receive vemurafenib (RO5185426) at a dose of 960 mg twice daily orally until disease progression or unacceptable toxicity occurs.

• Conditions: Metastatic Melanoma with Brain Metastases; MedDRA version: 14.1Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-000954-46-DE
• Lead Sponsor: F. Hoffman-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-31
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

•Adult patients, = 18 years of age
•Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF V600 mutation (cobas 4800 BRAF V600 Mutation Test)
•Measurable brain metastases, treated or untreated
•Patients may or may not have received prior systemic therapy for metastatic melanoma and either a) have received no prior treatment for brain metastases or b) have received prior treatment for brain metastases and have progressed
•Patients may or may not have symptoms related to their brain metastases
•Eastern Cooperative Oncology Group (ECOG) performance status 0-1
•Patients must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 106
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

•Increasing corticosteroid dose during the 7 days prior to first dose of study drug
•Leptominingeal involvement in patients with no prior treatment for brain metastases (cohort 1). Leptomeningeal involvement is only allowed in patients with prior treatment for brain metastases (cohort 2)
•Previous malignancy requiring active treatment within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix
•Concurrent administration of any anticancer therapies other than those administered in the study
•Treatment with any cytotoxic and/or investigational cytotoxic drug or targeted therapy = 4 weeks prior to first administration of vemurafenib and radiation therapy = 1 weeks prior to first administration of vemurafenib and stereotactic radiotherapy = 1 day prior to prior to first administration of vemurafenib.
•Prior treatment with BRAF or MEK inhibitors
•Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug
•History or presence of clinically significant cardiac dysrhythmia
•Corrected QT interval = 450 ms or history of congenital long QT syndrome

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified