BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations

Stopped early · Phase 1

Conditions studied: Malignant Melanoma

In brief

This open-label, multicenter. single arm Phase I dose-escalation study with efficacy tail extension will evaluate the maximum tolerated dose/recommended dose, the safety and efficacy of vemurafenib (RO5185426) in pediatric participants (aged 12 through 17) with newly diagnosed or recurrent surgically incurable and unresectable Stage IIIC or Stage IV melanoma harboring BRAFV600 mutations. Participants will receive vemurafenib orally twice daily until disease progression or unacceptable toxicity occurs.

Key facts

Study ID

NCT01519323

Run by

Hoffmann-La Roche

People needed

6

Starts

2013-01-01

Expected to finish

2015-12-01

Last updated by the study team

2016-10-10

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pediatric participants, 12 to 17 years of age inclusive
• Histologically confirmed surgically incurable and unresectable Stage IIIC or Stage IV (AJCC) melanoma
• Positive proto-oncogene B-Raf (BRAF) mutation result (Cobas 4800 BRAF V600 Mutation Test)
• Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria
• Performance status: Karnofsky (for participants >/= 16 years of age) or Lansky (for participants < 16 years of age) score of >/= 60
• Adequate bone marrow, liver and renal function
• Participants must have fully recovered from the acute toxic effects of all prior therapy prior to first administration of study drug

You may not qualify if…

• Active or untreated central nervous system (CNS) lesions
• History of or known spinal cord compression or carcinomatous meningitis
• Anticipated or ongoing administration of anti-cancer therapies other than those administered in this study
• Previous malignancy within the past 5 years except for basal or squamous cell carcinoma of the skin, melanoma in-situ, and carcinoma in-situ of the cervix
• Previous treatment with selective/specific BRAF or Methyl Ethyl Ketone (MEK) inhibitor (previous treatment with sorafenib is allowed)
• Any previous treatment with study drug (RO5185426) or participation in a clinical trial that includes RO5185426
• Pregnant or lactating females
• Known human immunodeficiency virus (HIV) positivity or acquired immune deficiency syndrome (AIDS)-related illness, active hepatitis B virus, or active hepatitis C virus

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Saint Petersburgh, Florida, United States
• Study site — Bethesda, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — New York, New York, United States
• Study site — Memphis, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Westmead, New South Wales, Australia
• Study site — Brisbane, Queensland, Australia
• Study site — Marseille, France
• Study site — Pierre-Bénite, France
• Study site — Kiel, Germany
• Study site — Mainz, Germany
• Study site — Tübingen, Germany
• Study site — Jerusalem, Israel
• Study site — Petah Tikva, Israel
• Study site — Rome, Lazio, Italy
• Study site — Genoa, Liguria, Italy
• Study site — Milan, Lombardy, Italy
• Study site — Wroclaw, Poland
• Study site — Bratislava, Slovakia
• Study site — Esplugues de Llobregas, Barcelona, Spain
• Study site — Seville, Sevilla, Spain
• Study site — Newcastle upon Tyne, United Kingdom

Full record on ClinicalTrials.gov

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