Clinical trial NCT01898585: An Open-Label Study of Zelboraf (Vemurafenib) in Patients With Braf V600 Mutation Positive Metastatic Melanoma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malignant Melanoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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 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.

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Overall response rate according to Response evaluation criteria in solid tumors (RECIST v1.1)
timeFrame: 12 months
measure: Progression free survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Bloemfontein
country: South Africa
facility: National Hospital; Oncotherapy Dept
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital ( Uni of Capetown ); Oncology Dept
city: Cape Town
country: South Africa
facility: Cape Town Oncology Trials
city: Cape Town
country: South Africa
facility: Cancercare
city: George
country: South Africa
facility: Cancercare
city: Groenkloof
country: South Africa
facility: Mary Potter Oncology Centre
city: Johannesburg
country: South Africa
facility: Medical Oncology Centre of Rosebank; Oncology
city: Pretoria
country: South Africa
facility: University of Pretoria; Department of Medical Oncology
city: Sandton
country: South Africa
facility: Sandton Oncology Medical Group
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: