Status:
COMPLETED
An Open-Label Study of Zelboraf (Vemurafenib) in Patients With Braf V600 Mutation Positive Metastatic Melanoma
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 Zel...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 17 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01898585
Start Date
October 17 2013
End Date
May 22 2019
Last Update
January 7 2020
Active Locations (9)
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1
National Hospital; Oncotherapy Dept
Bloemfontein, South Africa, 9301
2
Groote Schuur Hospital ( Uni of Capetown ); Oncology Dept
Cape Town, South Africa, 7506
3
Cape Town Oncology Trials
Cape Town, South Africa, 7570
4
Cancercare
Cape Town, South Africa, 7700