A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors
Start Date
4/22/2021
Completion Date
5/31/2027
Summary
This is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of Type II RAF (tovorafenib) in pediatric participants with low-grade glioma or advanced solid tumors. Qualifying genomic alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories prior to enrollment into any of the arms. The study will consist of a screening period, a treatment period, a long-term extension phase, end of treatment (EOT) visit(s), a safety follow-up visit, and long-term follow-up assessments.
Eligibility Criteria
Age Range: No minimum to 25 years
Interventions
Tovorafenib
Conditions
Locations
UCSF Benioff Children's Hospital
San Francisco, California 94143
United States
Children's National Medical Center
Washington D.C., District of Columbia 20010
United States
Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United States
Johns Hopkins Hospital
Baltimore, Maryland 21231
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
CS Mott Children's Hospital
Ann Arbor, Michigan 48109
United States
St. Louis Children's Hospital
St Louis, Missouri 63110
United States
NYU Langone Health
New York, New York 10016
United States
Duke Cancer Center
Durham, North Carolina 27710
United States
Doernbecher Children's Hospital Oregon & Health Science University
Portland, Oregon 97239
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
Texas Children's Hospital
Houston, Texas 77030
United States
University of Utah
Salt Lake City, Utah 84113
United States
Seattle Children's Hospital
Seattle, Washington 98105
United States
Queensland Children's Hospital
Brisbane, 4101
Australia
Royal Children's Hospital
Parkville, 3052
Australia
Perth Children's Hospital
Perth, WA 6009
Australia
Sydney Children's Hospital
Randwick, NSW 2031
Australia
The Children's Hospital at Westmead
Westmead, 2145
Australia
Centre Hospitalier Universitaire Ste-Justine
Montreal, Quebec H3T 1C5
Canada
Montreal Children's Hospital
Montreal, Quebec H4A 3J1
Canada
Centre Mère-Enfant Soleil du CHU
Québec, Quebec G1V 4G2
Canada
Rigshospitalet
Copenhagen,
Denmark
Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Otto-Heubner-Centrum für Kinder
Berlin, 13353
Germany
Hopp-Kindertumorzentrum Heidelberg (KiTZ), KiTZ Clinical Trial Unit (ZIPO)
Heidelberg, 69120
Germany
Rambam Health Care Campus
Haifa, 3109601
Israel
Schneider Children's Medical Center of Israel
Petah Tikva, 4920235
Israel
The Chaim Sheba Medical Center
Ramat Gan, 5265601
Israel
Princess Maxima Center for Pediatric Oncology
Utrecht, 3584 CS
Netherlands
KK Women's and Children's Hospital
Singapore, 229899
Singapore
Seoul National University Hospital
Seoul, 3080
South Korea
Severance Hospital - Yonsei University
Seoul, 3722
South Korea
Universitäts-Kinderspital Zürich - Eleonorenstiftung
Zurich, 8032
Switzerland
UCL Great Ormond Street Institute of Child Health
London, WC1N 1EH
United Kingdom
Newcastle University
Newcastle upon Tyne, NE1 7RU
United Kingdom