An Open-Label Study of Zelboraf (Vemurafenib) in Patients With Braf V600 Mutation Positive Metastatic Melanoma
Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malignant Melanoma
Intervention: Zelboraf (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s): Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
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.
Clinical Details
Official title: An Open-Label, Single-Arm, Multicenter Study To Assess The Safety Of Vemurafenib In Patients With Braf V600 Mutation Positive Metastatic Melanoma In South Africa.
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Safety: Incidence of adverse events
Secondary outcome: Overall response rate according to Response evaluation criteria in solid tumors (RECIST v1.1)Progression free survival
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 cobasĀ® 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.
Locations and Contacts
Bloemfontein 9301, South Africa
Cape Town 7700, South Africa
Cape Town 7570, South Africa
Cape Town 7506, South Africa
George 6529, South Africa
Groenkloof 0181, South Africa
Johannesburg 2196, South Africa
Pretoria 0002, South Africa
Sandton 2196, South Africa
Additional Information
Starting date: October 2013
Last updated: June 1, 2015
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