45
Participants
Start Date
June 30, 2014
Primary Completion Date
February 16, 2022
Study Completion Date
February 16, 2022
Cabozantinib
This is an open label Phase II clinical trial. For both cohorts, subjects will receive cabozantinib orally in continuous cycles. Each cycle is 28 days. In absence of progressive disease or dose limiting toxicity (DLT), subjects may continue therapy for a total of 24 cycles. Subjects with radiographic response (20% or greater reduction in tumor volume) at the end of 12 cycles can continue on therapy for up to an additional year. However, for Cohort A, subjects who do not achieve 15% reduction in tumor volume after 8 cycles will be considered treatment failure and taken off study. For Cohort B, the criteria that subjects who do not achieve 15% reduction by 8 cycles are considered treatment failure and taken off study was eliminated. Subjects will be carefully monitored for toxicities associated with cabozantinib.
New York University Medical Center, New York
Children's Hospital of Philadelphia, Philadelphia
Children's National Medical Center, Washington D.C.
National Cancer Institute (NCI), Bethesda
Cincinnati Children's Hospital Medical Center, Cincinnati
Indiana Unversity, Indianapolis
Lurie Children's Hospital of Chicago, Chicago
University of Chicago, Chicago
Washington University - St. Louis, St Louis
University of Utah, Salt Lake City
Children's Hospital Los Angeles, Los Angeles
Children' Hospital Boston and Massachusetts General Hospital, Boston
University of Alabama at Birmingham
OTHER