Unresectable or Metastatic Melanoma with V600 BRAF Mutation
Conditions
Interventions
investigational material(s)
Generic name etc : vemurafenib
INN of investigational material : vemurafenib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigat
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Step1 : Initial safety Step2 : Response rate Step1 : To assess the safety profile in cycle1 (Day1 to 28) Step2 : To assess the response rate according to RECIST criteria (version 1.1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, PK, efficacy, Dose intensity Safety : To assess safety profile according to CTCAE ver.4.03 PK : To measure plasma concentration and calculate the PK parameters Efficacy : To assess duration of response, disease control rate, disease free survival, overall survival Dose intensity : To assess the Dose intensity in every patient | — |
Outcome results
None listed