Metastatic Melanoma with Brain Metastases MedDRA version: 14.1 Level: LLT Classification code 10027481 Term: Metastatic melanoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: RO5185426/F17
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Vemurafenib
CAS Number: 918504-65-1
Current Sponsor code: RO5185426-006
Other descriptive name: RG7204, PLX4032
Sponsors
F. Hoffman-La Roche Ltd.
Eligibility
Sex/Gender
All
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 106 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: •Increasing corticosteroid dose during the 7 days prior to first dose of study drug •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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of vemurafenib using Best Overall Response Rate (BORR), as assessed by an Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST, v1.1) in the brain of metastatic melanoma patients with previously untreated brain metastases;Secondary Objective: • To evaluate the efficacy of vemurafenib using BORR in the brain of patients with previously treated or untreated brain metastases assessed 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, duration of response (DOR) in and outside of the brain, progression-free survival (PFS), time to development of new brain metastases in responding patients, and overall survival (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;Primary end point(s): Best Overall Response Rate (BORR) in previously untreated brain metastases (assessed by Independent Review Committee using RECIST) ;Timepoint(s) of evaluation of this end point: June 2012 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •BORR in previously treated or untreated brain metastases (assessed by Independent Review Committee) •BORR in previously treated brain metastases (assessed by Independent Review Committee) •BORR outside of the brain (assessed by Independent Review Committee) •BORR in brain metastases and outside of the brain (assessed by Investigator) •Duration Of Response, Progression Free Survival, time to development of new brain metastases, Overall Survival •Safety (assessed by NCI CTCAE) ;Timepoint(s) of evaluation of this end point: June 2014 | — |
Countries
Australia, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd.
Outcome results
None listed