An Open-Label Study of Zelboraf (Vemurafenib) in Patients With Braf V600 Mutation Positive Metastatic Melanoma

• ClinicalTrials.gov Identifier: NCT01898585
• Recruitment Status: Completed
• First Posted: July 12, 2013
• Last Update Posted: January 7, 2020
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Malignant Melanoma	Drug: Zelboraf	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: October 17, 2013
• Actual Primary Completion Date: May 22, 2019
• Actual Study Completion Date: May 22, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Zelboraf Arm	Drug: Zelboraf; Vemurafenib 960 mg twice a day until progressive disease, unacceptable toxicity, consent withdrawal, death, reasons deemed by the treating physician or study termination.

Outcome Measures

Primary Outcome Measures :

1. Safety: Incidence of adverse events [ Time Frame: 12 months ]

Secondary Outcome Measures :

1. Overall response rate according to Response evaluation criteria in solid tumors (RECIST v1.1) [ Time Frame: 12 months ]
2. Progression free survival [ Time Frame: 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

South Africa

National Hospital; Oncotherapy Dept

Bloemfontein, South Africa, 9301

Groote Schuur Hospital ( Uni of Capetown ); Oncology Dept

Cape Town, South Africa, 7506

Cape Town Oncology Trials

Cape Town, South Africa, 7570

Cancercare

Cape Town, South Africa, 7700

Cancercare

George, South Africa, 6529

Mary Potter Oncology Centre

Groenkloof, South Africa, 0181

Medical Oncology Centre of Rosebank; Oncology

Johannesburg, South Africa, 2196

University of Pretoria; Department of Medical Oncology

Pretoria, South Africa, 0002

Sandton Oncology Medical Group

Sandton, South Africa, 2196

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

More Information

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01898585
• Other Study ID Numbers: ML28711
• First Posted: July 12, 2013
• Last Update Posted: January 7, 2020
• Last Verified: January 2020

Additional relevant MeSH terms:

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Vemurafenib; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action