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Trial record 1 of 1 for:    NCT01898585
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An Open-Label Study of Zelboraf (Vemurafenib) in Patients With Braf V600 Mutation Positive Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT01898585
Recruitment Status : Active, not recruiting
First Posted : July 12, 2013
Last Update Posted : November 13, 2017
Information provided by (Responsible Party):

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
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
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Vemurafenib
U.S. FDA Resources

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

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01898585

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
Cape Town, South Africa, 7700
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 Centre
Sandton, South Africa, 2196
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01898585     History of Changes
Other Study ID Numbers: ML28711
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action