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

Tracking Information

• First Submitted Date: July 9, 2013
• First Posted Date: July 12, 2013
• Last Update Posted Date: January 7, 2020
• Actual Study Start Date: October 17, 2013
• Actual Primary Completion Date: May 22, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 9, 2013): Safety: Incidence of adverse events [ Time Frame: 12 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 9, 2013)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Open-Label Study of Zelboraf (Vemurafenib) in Patients With Braf V600 Mutation Positive Metastatic Melanoma
• 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.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Malignant 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.

Study Arms

Experimental: Zelboraf Arm

Intervention: Drug: Zelboraf

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 9, 2013): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 22, 2019
• Actual Primary Completion Date: May 22, 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: South Africa

Administrative Information

• NCT Number: NCT01898585
• Other Study ID Numbers: ML28711
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Hoffmann-La Roche
• Study Sponsor: Hoffmann-La Roche
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

• PRS Account: Hoffmann-La Roche
• Verification Date: January 2020