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

NCT01898585 | Completed Phase 4

• 1 other identifier: ML28711
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 9

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.

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

• Safety: Incidence of adverse events

  12 months

Secondary Outcomes (2)

• Overall response rate according to Response evaluation criteria in solid tumors (RECIST v1.1)

  12 months

• Progression free survival

  12 months

Study Arms (1)

Zelboraf Arm

EXPERIMENTAL

Drug: Zelboraf

Interventions

Zelboraf DRUG

Vemurafenib 960 mg twice a day until progressive disease, unacceptable toxicity, consent withdrawal, death, reasons deemed by the treating physician or study termination.

Zelboraf Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (9)

National Hospital; Oncotherapy Dept

Bloemfontein, 9301, South Africa

Location

Groote Schuur Hospital ( Uni of Capetown ); Oncology Dept

Cape Town, 7506, South Africa

Location

Cape Town Oncology Trials

Cape Town, 7570, South Africa

Location

Cancercare

Cape Town, 7700, South Africa

Location

Cancercare

George, 6529, South Africa

Location

Mary Potter Oncology Centre

Groenkloof, 0181, South Africa

Location

Medical Oncology Centre of Rosebank; Oncology

Johannesburg, 2196, South Africa

Location

University of Pretoria; Department of Medical Oncology

Pretoria, 0002, South Africa

Location

Sandton Oncology Medical Group

Sandton, 2196, South Africa

Location

MeSH Terms

Conditions

Melanoma

Interventions

Vemurafenib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: July 12, 2013
• Study Start: October 17, 2013
• Primary Completion: May 22, 2019
• Study Completion: May 22, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

ZA (9)