Melanoma Clinical Trial

A Study of Vemurafenib in Metastatic Melanoma Participants With Brain Metastases

Summary

This open-label, single-arm, multicenter study will evaluate the efficacy and safety in participants with metastatic melanoma who developed brain metastases. Participants may or may not have received prior systemic treatment for metastatic melanoma [except treatment with v-raf murine sarcoma viral oncogene homolog B (BRAF) or mitogen-activated protein kinase (MEK) inhibitors]. Participants will receive oral doses of 960 mg vemurafenib twice daily until disease progression, unacceptable toxicity or consent withdrawal.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Adult participants, >/= 18 years of age
Histologically confirmed metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF V600 mutation (cobas 4800 BRAF V600 Mutation Test)
Measurable brain metastases, defined as lesions that were accurately measured in at least one dimension (longest diameter to be recorded) as ≥0.5 cm in the brain MRI with contrast, treated or untreated
Participants 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
Participants may or may not have symptoms related to their brain metastases
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Participants 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 in participants with no prior treatment for brain metastases
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 ≤1 week prior to first administration of vemurafenib; and stereotactic radiotherapy ≤1 day prior to prior to first administration of vemurafenib
Prior treatment with BRAF or MEK inhibitors
Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

146

Study ID:

NCT01378975

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 33 Locations for this study

See Locations Near You


Los Angeles California, 90025, United States

Aurora Colorado, 80045, United States

Tampa Florida, 33612, United States

Boston Massachusetts, 02114, United States

Boston Massachusetts, 02215, United States

Detroit Michigan, 48201, United States

Rochester Minnesota, 55905, United States

Saint Louis Missouri, 63110, United States

Charlotte North Carolina, 28204, United States

Dallas Texas, 75246, United States

Seattle Washington, 98195, United States

Wentworthville New South Wales, 2145, Australia

Melbourne Victoria, 3002, Australia

Toronto Ontario, M4N 3, Canada

Bordeaux , 33075, France

Nice , 06202, France

Paris , 75006, France

Paris , 75475, France

Essen , 45122, Germany

Frankfurt , 60596, Germany

Kiel , 24105, Germany

Mannheim , 68167, Germany

Münster , 48157, Germany

Tübingen , 72076, Germany

Tel-Hashomer , 52621, Israel

Milano Lombardia, 20133, Italy

Siena Toscana, 53100, Italy

Amsterdam , 1066 , Netherlands

Groningen , 9713 , Netherlands

Pamplona Navarra, 31008, Spain

Barcelona , 08036, Spain

Madrid , 28046, Spain

Northwood , HA6 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

146

Study ID:

NCT01378975

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

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