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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

Page last updated: August 20, 2015

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