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 :
Completed
First Posted : July 12, 2013
Last Update Posted : January 7, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malignant Melanoma | Drug: Zelboraf | Phase 4 |
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 |

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. |
- Safety: Incidence of adverse events [ Time Frame: 12 months ]
- Overall response rate according to Response evaluation criteria in solid tumors (RECIST v1.1) [ Time Frame: 12 months ]
- Progression free survival [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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.

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 | |
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 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT01898585 |
Other Study ID Numbers: |
ML28711 |
First Posted: | July 12, 2013 Key Record Dates |
Last Update Posted: | January 7, 2020 |
Last Verified: | January 2020 |
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 |