A Study of Vemurafenib (Zelboraf) in Chinese Participants With BRAF V600 Mutation-Positive Unresectable or Metastatic Melanoma

Launched by HOFFMANN-LA ROCHE · Jul 25, 2013

Keywords

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Gender

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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