A Study of Vemurafenib (Zelboraf) in Chinese Participants With BRAF V600 Mutation-Positive Unresectable or Metastatic Melanoma
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: Vemurafenib
Intervention description: Participants will receive vemurafenib at a dose of 960 mg twice daily orally.
Intervention MeSH terms: Vemurafenib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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