An open-label, single-arm, phase II, multicenter study to evaluate;the efficacy of vemurafenib in metastatic melanoma patients with brain metastases
- Conditions
- aggressive skin cancermetastatic melanoma10027476
- Registration Number
- NL-OMON37956
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
•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
•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 <= 4 weeks prior to first administration of vemurafenib and radiation therapy <= 1 weeks prior to first administration of vemurafenib and stereotactic radiotherapy <= 1 day prior to first administration of vemurafenib.•Prior treatment with BRAF or MEK inhibitors;•Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug ;•History or presence of clinically significant cardiac dysrhythmia;•Corrected QT interval >= 450 ms or history of congenital long QT syndrome;•Pregnant or lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this trial is to evaluate the efficacy of vemurafenib<br /><br>using Best<br /><br>Overall Response Rate (BORR), as assessed by an Independent Review Committee<br /><br>(IRC)<br /><br>using RECIST, v1.1 criteria in the brain of metastatic melanoma patients with<br /><br>previously<br /><br>untreated brain metastases</p><br>
- Secondary Outcome Measures
Name Time Method