Vemurafenib in Children With Recurrent/Refractory BRAF Gene V600E (BRAFV600E)-Mutant Gliomas

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

April 29, 2014

Primary Completion Date

December 5, 2018

Study Completion Date

July 31, 2025

Conditions
Pediatric Recurrent/Refractory BRAFV600E-mutant Gliomas
Interventions
DRUG

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."

Trial Locations (21)

19104

Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Medical Center, Washington D.C.

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

32610

University of Florida Health Science Center - Gainesville, Gainesville

38105

St. Jude Children's Research Hospital, Memphis

43205

Nationwide Children's Hospital, Columbus

55454

University of Minnesota/Masonic Children's Hospital, Minneapolis

60611

Lurie Children's Hospital-Chicago, Chicago

63110

Saint Louis Children's Hospital, St Louis

77030

Texas Children's Hospital, Houston

84112

Huntsman Cancer Institute/University of Utah, Salt Lake City

90027

Children's Hospital Los Angeles, Los Angeles

90095

Mattel Children's Hospital UCLA, Los Angeles

92123

Rady Children's Hospital - San Diego, San Diego

94115

UCSF Medical Center-Mount Zion, San Francisco

94143

UCSF Medical Center-Parnassus, San Francisco

97239

Oregon Health and Science University, Portland

98105

Seattle Children's Hospital, Seattle

94609-1809

Children's Hospital and Research Center at Oakland, Oakland

02215

Dana-Farber Cancer Institute, Boston

M5G 1X8

Hospital for Sick Children, Toronto

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

University of California, San Francisco

OTHER

NCT01748149 - Vemurafenib in Children With Recurrent/Refractory BRAF Gene V600E (BRAFV600E)-Mutant Gliomas | Biotech Hunter | Biotech Hunter