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

Malignant Melanoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01898585
• Other study ID #: ML28711
• Status: Completed
• Phase: Phase 4
• Start date: October 17, 2013
• Est. completion date: May 22, 2019

Study information

• Verified date: January 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 22, 2019
• Est. primary completion date: May 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

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.

Locations

Country	Name	City	State
South Africa	National Hospital; Oncotherapy Dept	Bloemfontein
South Africa	Cancercare	Cape Town
South Africa	Cape Town Oncology Trials	Cape Town
South Africa	Groote Schuur Hospital ( Uni of Capetown ); Oncology Dept	Cape Town
South Africa	Cancercare	George
South Africa	Mary Potter Oncology Centre	Groenkloof
South Africa	Medical Oncology Centre of Rosebank; Oncology	Johannesburg
South Africa	University of Pretoria; Department of Medical Oncology	Pretoria
South Africa	Sandton Oncology Medical Group	Sandton

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		12 months
Secondary	Overall response rate according to Response evaluation criteria in solid tumors (RECIST v1.1)		12 months
Secondary	Progression free survival		12 months