Roche trials database

Trial information

A Study of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases

Status:

Recruiting

Protocol number:

MO25743

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific Title:

An open-label, single-arm, phase II, multicenter study, to evaluate the efficacy of vemurafenib in metastatic melanoma patients with brain metastases

Brief summary:

This open-label, single-arm, multicenter study will evaluate the efficacy and safety in patients with metastatic melanoma who developed brain metastases. Patients may or may not have received prior treatment for metastatic melanoma with brain metastases (except treatment with BRAF or MEK inhibitors). Patients will receive oral doses of 960 mg vemurafenib twice daily until disease progression, unacceptable toxicity or consent withdrawal. Target sample size is 132.

Study phase:

II

Study type:

Interventional; Treatment; Non-randomized; Single group; Safety/efficacy study

Conditions:

• Malignant Melanoma

Intervention type:

Drug

Intervention name:

vemurafenib

Primary outcome:

1. Best Overall Response Rate (BORR) in previously untreated brain metastases (assessed by Independent Review Committee using Response Evaluation Criteria in Solid Tumors (RECIST)) Time frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)

Key secondary outcomes:

1. Best Overall Response Rate in previously treated or untreated brain metastases (assessed by Independent Review Committee)\n Time frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)
2. Best Overall Response Rate in previously treated brain metastases (assessed by Independent Review Committee)\n Time frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)
3. Safety: Incidence of adverse events Time frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)
4. Best Overall Response Rate outside of the brain (assessed by Independent Review Committee) Time frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)
5. Duration of response Time frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)
6. Progression-free survival Time frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)
7. Time to development of new brain metastases in responding patient Time frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)
8. Overall survival Time frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)
9. Best Overall Response Rate in brain metastases and outside of the brain (assessed by Investigator) Time frame: Until disease progression, unacceptable toxicity or consent withdrawal (approximately 2 years)

Inclusion criteria:

• Adult patients, >/= 18 years of age
• Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF V600 mutation (cobas 4800 BRAF V600 Mutation Test)
• Measurable brain metastases, treated or untreated
• Patients may or may not have received prior systemic therapy for metastatic melanoma and either a) have received no prior treatment for brain metastases or b) have received prior treatment for brain metastases and have progressed
• Patients may or may not have symptoms related to their brain metastases
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Patients must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma

Exclusion criteria:

• Increasing corticosteroid dose during the 7 days prior to first dose of study drug
• Leptomeningeal involvement
• Previous malignancy requiring active treatment within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix
• Concurrent administration of any anticancer therapies other than those administered in the study
• Treatment with any cytotoxic, investigational drug or targeted therapy 4 weeks prior to first dose of study drug. Radiation therapy 2 weeks prior to first dose of study drug
• Prior treatment with BRAF or MEK inhibitors
• Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug

Gender:

Males or Females

Age limits:

Min: 18 years Max: N/A (No limit)

Accepts healthy volunteers:

No

Anticipated start date:

July, 2011

Trial registration date:

06.06.2011

Date last updated:

06.05.2013

This trial is being conducted at the following locations:

Australia

• MELBOURNE
• WENTWORTHVILLE

Canada

• TORONTO, ON

France

• BORDEAUX
• LILLE
• NICE
• PARIS

Germany

• ESSEN
• FRANKFURT
• KIEL
• MANNHEIM
• MÜNSTER
• TÜBINGEN

Israel

• TEL-HASHOMER

Italy

• MILANO
• SIENA

Netherlands

• AMSTERDAM
• GRONINGEN

Spain

• BARCELONA
• MADRID
• PAMPLONA

U.S.A.

• LOS ANGELES, CA
• AURORA, CO
• TAMPA, FL
• BOSTON, MA
• DETROIT, MI
• ROCHESTER, MN
• ST. LOUIS, MO
• CHARLOTTE, NC
• LAS VEGAS, NV
• DALLAS, TX
• SEATTLE, WA

United Kingdom

• NORTHWOOD

Link to trial result