Status:
COMPLETED
A Study of Vemurafenib (Zelboraf) in Chinese Participants With BRAF V600 Mutation-Positive Unresectable or Metastatic Melanoma
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 17 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2018
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01910181
Start Date
August 17 2013
End Date
April 20 2018
Last Update
May 29 2019
Active Locations (2)
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1
Beijing Cancer Hospital
Beijing, China, 100142
2
Sun Yet-sen University Cancer Center
Guangzhou, China, 510060