A study to expand access to vemurafenib for patients with BRAFV600 mutation-positive unresectable/recurrent melanoma.
- Conditions
- melanoma
- Registration Number
- JPRN-UMIN000015572
- Lead Sponsor
- ational Cancer Center Hospital East
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
(1)Patients with brain metastases However, they will be eligible if they have only asymptomatic brain metastases treated by surgical resection or stereotaxic radiation therapy and diagnosed by the investigator/subinvestigators as being free of symptoms, with imaging evidence of stable disease. (2)Patients with concurrent malignancies with a disease-free period of less than 2 years, except cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in situ, and metastatic prostate cancer that has increased prostate-specific antigen (PSA) levels but is not clinically diagnosed by imaging (3)Patients who are pregnant or nursing (4)Patients with difficulty taking oral medications (5)Patients who require concomitant use of other anticancer treatments (e.g., chemotherapy, other molecular-targeted agents, radiation therapy, and other investigational or experimental drugs) (6)Patients who have had the following medical conditions within 6 months prior to the first dose of study drug: Myocardial infarction, severe or unstable angina pectoris, symptomatic congestive heart failure, cerebrovascular disease or transient ischemic attack, pulmonary embolism, and inadequately controlled hypertension (7)Patients with a mean corrected QT (QTc) interval of 450 msec or longer at screening (8)Patients with Grade 2 (as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 4.0) or greater arrhythmia (9)Patients with inadequately controlled concurrent medical conditions (e.g., those requiring intravenous antibiotic therapy) (10)Patients who are unable to use acceptable methods of contraception (11)Patients who are, in the opinion of the investigator/subinvestigators, ineligible for participation in the study for any other reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety Outcome Measures # Incidence, type, and severity of AEs # Incidence and nature of serious adverse events (SAEs) # Incidence of AEs leading to vemurafenib discontinuation or interruption # Cause of death on study
- Secondary Outcome Measures
Name Time Method