An Open-Label Study of Zelboraf (Vemurafenib) in Patients With Braf V600 Mutation Positive Metastatic Melanoma
- Registration Number
- NCT01898585
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This open-label, single-arm, multicenter study will assess the safety and efficacy of Zelboraf (vemurafenib) in patients with Braf V600 mutation positive metastatic melanoma. Patients will receive Zelboraf 960 mg twice a day until progressive disease, unacceptable toxicity, consent withdrawal, death, reasons deemed by the treating physician or study termination.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Adults patients >= 18 years of age
- Patients with histologically confirmed metastatic melanoma (surgically incurable and unresectable stage IIIC or stage IV; AJCC) with documented BRAF V600 mutation determined by the cobas® BRAF V600 Mutation Test prior to administration of vemurafenib. Unresectable stage IIIC disease must have confirmation from a surgical oncologist
- Patients with either measurable or non-measurable disease (RECIST Version 1.1)
- Patients may or may not have received prior systemic therapy for metastatic melanoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Patients must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma
- Adequate hematological, renal, and liver function
- Negative serum pregnancy test at screening
- Fertile men and women must use an effective form of contraception during the study and for at least 6 months after completion of the study
- Evidence of symptomatic CNS lesions as determined by the investigator, use of steroid or anti-seizure medication for treatment of brain metastases prior to the first administration of vemurafenib
- Patients with previous malignancies (other than melanoma) within the past 2 years except patients with treated and controlled basal or squamous cell carcinoma (SCC) of the skin or carcinoma in-situ of the cervix.
- Concurrent administration of any anti-cancer therapies (e.g. chemotherapy, other targeted therapy, experimental drug, etc.) other than those administered in this study
- Known hypersensitivity to vemurafenib or another BRAF inhibitor
- Pregnant or lactating women
- Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption.
- Any of the following within the 6 months prior to the first vemurafenib administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischaemic attack, pulmonary embolism, hypertension not adequately controlled by current medications.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zelboraf Arm Zelboraf -
- Primary Outcome Measures
Name Time Method Safety: Incidence of adverse events 12 months
- Secondary Outcome Measures
Name Time Method Overall response rate according to Response evaluation criteria in solid tumors (RECIST v1.1) 12 months Progression free survival 12 months
Trial Locations
- Locations (8)
Groote Schuur Hospital ( Uni of Capetown ); Oncology Dept
🇿🇦Cape Town, South Africa
Medical Oncology Centre of Rosebank; Oncology
🇿🇦Johannesburg, South Africa
Mary Potter Oncology Centre
🇿🇦Groenkloof, South Africa
University of Pretoria; Department of Medical Oncology
🇿🇦Pretoria, South Africa
Sandton Oncology Medical Group
🇿🇦Sandton, South Africa
Cape Town Oncology Trials
🇿🇦Cape Town, South Africa
Cancercare
🇿🇦George, South Africa
National Hospital; Oncotherapy Dept
🇿🇦Bloemfontein, South Africa