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

• Status: Completed
• Trial end date: 2018-04-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Vemurafenib

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