40
Participants
Start Date
April 29, 2014
Primary Completion Date
December 5, 2018
Study Completion Date
July 31, 2025
Vemurafenib
"Vemurafenib is supplied in 120-mg and 240-mg film-coated tablets packed in bottles for oral administration. Dosing is based on the body surface area (BSA) calculated at the beginning of each course of therapy. The dose prescribed should be rounded to the nearest deliverable dose based on the BSA adjustment and the available pill sizes. Dosing will not exceed the adult MTD of 960 mg twice a day (BID). Patients will be provided with a Medication Diary for vemurafenib, instructed in its use, and asked to bring the diary with them to each appointment.~Treatment will be administered on an outpatient basis. Dosing is based on the BSA calculated at the beginning of each course of therapy. The dose prescribed should be rounded to the nearest deliverable dose based on the BSA adjustment and the available pill sizes. Regardless of cohort, patients will self-administer vemurafenib BID at the assigned dose level. Patients will be instructed to hold their dose of vemurafenib for PK or surgery."
Children's Hospital of Philadelphia, Philadelphia
Children's National Medical Center, Washington D.C.
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore
University of Florida Health Science Center - Gainesville, Gainesville
St. Jude Children's Research Hospital, Memphis
Nationwide Children's Hospital, Columbus
University of Minnesota/Masonic Children's Hospital, Minneapolis
Lurie Children's Hospital-Chicago, Chicago
Saint Louis Children's Hospital, St Louis
Texas Children's Hospital, Houston
Huntsman Cancer Institute/University of Utah, Salt Lake City
Children's Hospital Los Angeles, Los Angeles
Mattel Children's Hospital UCLA, Los Angeles
Rady Children's Hospital - San Diego, San Diego
UCSF Medical Center-Mount Zion, San Francisco
UCSF Medical Center-Parnassus, San Francisco
Oregon Health and Science University, Portland
Seattle Children's Hospital, Seattle
Children's Hospital and Research Center at Oakland, Oakland
Dana-Farber Cancer Institute, Boston
Hospital for Sick Children, Toronto
Collaborators (1)
Genentech, Inc.
INDUSTRY
University of California, San Francisco
OTHER