The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
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
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:
Minimum Age: 12 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
, 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
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR