PhaseI/IIstudy of vemurafenib in patients with Melanoma with V600 BRAF Mutatio
- Conditions
- nresectable or Metastatic Melanoma with V600 BRAF Mutation
- Registration Number
- JPRN-jRCT2080221895
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 11
Patients with histologically or cytologically confirmed unresectable or meastatic melanoma
-Patients must have positive BRAF V600 mutation result determined by cobas(R) 4800 BRAF V600 mutation test
-Measurable disease ( by RECIST criteria version 1.1) prior to the administration of study treatment
-Patients with brain metastasis which lead to any clinical symptoms or need any treatments. However patients treated with surgery or stereotactic therapy are eligible if patients remains without evidence of disease progression in brain >= 3 months
-Patients who have been previously treated with whole-brain irradiation
-Patients with uncontrolled hypertension or diabetic mellitus
-Patients who have been previously treated with a BRAF inhibitor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method