Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study of Vemurafenib (Zelboraf) in Chinese Participants With BRAF V600 Mutation-Positive Unresectable or Metastatic Melanoma
