Malignant Melanoma
Conditions
Brief summary
This open-label, single-arm, multicenter study will assess the safety and efficacy of Zelboraf (vemurafenib) in patients with Braf V600 mutation positive metastatic melanoma. Patients will receive Zelboraf 960 mg twice a day until progressive disease, unacceptable toxicity, consent withdrawal, death, reasons deemed by the treating physician or study termination.
Interventions
DRUGZelboraf
Vemurafenib 960 mg twice a day until progressive disease, unacceptable toxicity, consent withdrawal, death, reasons deemed by the treating physician or study termination.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults patients \>= 18 years of age * Patients with histologically confirmed metastatic melanoma (surgically incurable and unresectable stage IIIC or stage IV; AJCC) with documented BRAF V600 mutation determined by the cobas® BRAF V600 Mutation Test prior to administration of vemurafenib. Unresectable stage IIIC disease must have confirmation from a surgical oncologist * Patients with either measurable or non-measurable disease (RECIST Version 1.1) * Patients may or may not have received prior systemic therapy for metastatic melanoma * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * Patients must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma * Adequate hematological, renal, and liver function * Negative serum pregnancy test at screening * Fertile men and women must use an effective form of contraception during the study and for at least 6 months after completion of the study
Exclusion criteria
* Evidence of symptomatic CNS lesions as determined by the investigator, use of steroid or anti-seizure medication for treatment of brain metastases prior to the first administration of vemurafenib * Patients with previous malignancies (other than melanoma) within the past 2 years except patients with treated and controlled basal or squamous cell carcinoma (SCC) of the skin or carcinoma in-situ of the cervix. * Concurrent administration of any anti-cancer therapies (e.g. chemotherapy, other targeted therapy, experimental drug, etc.) other than those administered in this study * Known hypersensitivity to vemurafenib or another BRAF inhibitor * Pregnant or lactating women * Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption. * Any of the following within the 6 months prior to the first vemurafenib administration: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischaemic attack, pulmonary embolism, hypertension not adequately controlled by current medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Incidence of adverse events | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate according to Response evaluation criteria in solid tumors (RECIST v1.1) | 12 months |
| Progression free survival | 12 months |
Countries
South Africa
Outcome results
None listed