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Spots Global Cancer Trial Database for BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations

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Trial Identification

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

Official Title: An Open-label, Multicenter, Single-arm, Phase I Dose-escalation With Efficacy Tail Extension Study of Vemurafenib (RO5185426) in Pediatric Patients With Surgically Incurable and Unresectable Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations

Study ID: NCT01519323

Interventions

vemurafenib

Study Description

Brief Summary: 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.

Detailed Description:

Keywords

Eligibility

Minimum Age: 12 Years

Eligible Ages: CHILD

Sex: ALL

Healthy Volunteers: No

Locations

, Los Angeles, California, United States

, Aurora, Colorado, United States

, St. Petersburgh, Florida, United States

, Bethesda, Maryland, United States

, Boston, Massachusetts, United States

, New York, New York, United States

, Memphis, Tennessee, United States

, Houston, Texas, United States

, Westmead, New South Wales, Australia

, Brisbane, Queensland, Australia

, Marseille, , France

, Pierre Benite, , France

, Kiel, , Germany

, Mainz, , Germany

, Tuebingen, , Germany

, Jerusalem, , Israel

, Petach-Tikva, , Israel

, Roma, Lazio, Italy

, Genova, Liguria, Italy

, Milano, Lombardia, Italy

, Wroclaw, , Poland

, Bratislava, , Slovakia

, Esplugues De Llobregas, Barcelona, Spain

, Sevilla, , Spain

, Newcastle upon Tyne, , United Kingdom

, Sutton, , United Kingdom

Contact Details

Name: Clinical Trials

Affiliation: Hoffmann-La Roche

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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