a study of vemurafenib (zelboraf) in chinese participants with braf v600 mutation-positive unresectable or metastatic melanoma

Conditions: Malignant Melanoma

Summary: this open-label, multicenter study will evaluate the pharmacokinetics, safety and efficacy of vemurafenib in chinese participants with braf v600 mutation-positive unresectable or metastatic melanoma. participants will receive vemurafenib 960 milligrams (mg) orally twice daily until disease progression or unacceptable toxicity occurs.


Eligibility criteria:
inclusion criteria: * chinese male or female participants, greater than or equal to (≥) 18 years of age * histologically confirmed metastatic melanoma (surgically unresectable stage iiic or stage iv, american joint committee on cancer) * treatment-naïve or having received prior systemic treatments for metastatic melanoma * positive braf v600 mutation result determined by a designated laboratory using the cobas 4800 braf v600 mutation test * measurable disease by response evaluation criteria in solid tumors (recist) v1.1 * previous allowed chemotherapy, immunotherapy, or radiation therapy must have been completed at least 2 weeks prior to study drug administration, and all associated toxicity must be resolved (to less than or equal to \[≤\] grade 1 or baseline) * recovery from effects of any major surgery (excluding tumor biopsy at baseline) or significant traumatic injury at least 14 days before the first dose of study treatment * adequate hematologic, renal, and liver function as defined by protocol * fertile men and women must use an effective method of contraception during treatment and for ≥6 months after completion of treatment as directed by their physician (in accordance with local requirements). * eastern cooperative oncology group (ecog) performance status of 0 or 1 * life expectancy greater than (\>) 3 months * able to swallow pills exclusion criteria: * active central nervous system (cns) lesions (radiographically unstable/symptomatic lesions), except participants treated with stereotactic therapy or surgery who remain without evidence of disease progression in brain for ≥3 months and have been off corticosteroid and anticonvulsant therapy for ≥3 weeks * history of or known spinal cord compression or carcinomatous meningitis * anticipated or ongoing administration of anti-cancer therapies other than those administered in this study * active squamous cell carcinoma (scc) that has not been excised or has not yet adequately healed post excision * pregnant or lactating women * refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate vemurafenib absorption * any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, serious cardiac arrhythmia requiring medication, uncontrolled hypertension, cerebrovascular accident or transient ischemic attack, or symptomatic pulmonary embolism * known clinically significant active infection * history of allogeneic bone marrow transplantation or organ transplantation * previous malignancy within the past 5 years other than adequately treated basal cell carcinoma or scc of the skin, melanoma in-situ, and carcinoma in-situ of the cervix and/or curatively treated cancer from which the participant is currently disease-free, or any malignancy from which the participant has been continuously disease-free for at least 5 years * previous treatment with a braf inhibitor (sorafenib allowed) or mek inhibitor * participants who have had one or more doses of vemurafenib in a previous clinical trial * known human immunodeficiency virus (hiv) positivity or acquired immune deficiency syndrome (aids)-related illness, or hepatitis b virus or hepatitis c virus (hcv) carriers (hepatitis b surface antigen-positive, hcv antibody-positive) * received any investigational treatment within 4 weeks of study drug start