aggressive skin cancer metastatic melanoma
Conditions
Interventions
Patients take orally 2x daily 4 tablets RO5185426.
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: •Adult patients, >= 18 years of age ;•Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF V600 mutation (cobas 4800 BRAF V600 Mutation Test) ;•Measurable brain metastases, treated or untreated;•Patients may or may not have received prior systemic therapy for metastatic melanoma and either a) have received no prior treatment for brain metastases or b) have received prior treatment for brain metastases and have progressed;•Patients may or may not have symptoms related to their brain metastases;•Eastern Cooperative Oncology Group (ECOG) performance status 0-1 ;•Patients must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma
Exclusion criteria
Exclusion criteria: •Increasing corticosteroid dose during the 7 days prior to first dose of study drug;2. Leptominingeal involvement in patients with no prior treatment for brain metastases (cohort 1). Leptomeningeal involvement is only allowed in patients with prior treatment for brain metastases (cohort 2). •Previous malignancy requiring active treatment within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix ;•Concurrent administration of any anticancer therapies other than those administered in the study ;•Treatment with any cytotoxic and/or investigational cytotoxic drug or targeted therapy = 450 ms or history of congenital long QT syndrome;•Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this trial is to evaluate the efficacy of vemurafenib using Best Overall Response Rate (BORR), as assessed by an Independent Review Committee (IRC) using RECIST, v1.1 criteria in the brain of metastatic melanoma patients with previously untreated brain metastases | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of vemurafenib using BORR in the brain of patients with previously treated or untreated brain metastases assesses by an IRC using RECIST v1.1 criteria • To evaluate the efficacy of vemurafenib using BORR in the brain of patients with previously-treated brain metastases as assessed by an IRC using RECIST v1.1 criteria • To evaluate the safety and tolerability of vemurafenib in patients with melanoma metastatic to the brain, as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE, v4.0) • To evaluate BORR outside of the brain as assessed by an IRC, DOR in and outside of the brain, PFS, time to development of new brain metastasis in responding patients, and OS in patients with melanoma metastatic to the brain To evaluate the efficacy of vemurafenib using BORR in the brain and outside of the brain of patients with previously untreated and/or previously treated brain metastates as assessed by the Investigator. | — |
Countries
Netherlands
Outcome results
None listed