Spots Global Cancer Trial Database for A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors
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.
Trial Identification
Brief Title: A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors
Official Title: A Phase 1/2 Study of the Oral RET Inhibitor LOXO 292 in Pediatric Patients With Advanced RET-Altered Solid or Primary Central Nervous System Tumors
Study ID: NCT03899792
Interventions
Study Description
Brief Summary: This is an open-label, multi-center Phase 1/2 study of oral LOXO-292 in pediatric participants with an activating rearranged during transfection (RET) alteration and an advanced solid or primary CNS tumor.
Detailed Description: This study includes 2 parts: phase 1 (dose escalation) and phase 2 (dose expansion). In phase 1, participants will be enrolled using a rolling 6 dose escalation scheme. The starting dose of LOXO-292 is equivalent to the adult recommended phase 2 dose of 160 milligrams (mg) twice a day (BID). Once the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) is identified, participants will be enrolled to one of four phase 2 dose expansion cohorts depending on tumor histology and tumor genotype. Cycle length will be 28 days.
Keywords
Eligibility
Minimum Age: 6 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Childrens Hospital of Los Angeles, Los Angeles, California, United States
The Children's Hospital for Cancer and Blood Disorders, Aurora, Colorado, United States
Nemours Children's Health, Orlando, Florida, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University Of Minnesota Hospital, Minneapolis, Minnesota, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, United States
Texas Childrens Hospital, Houston, Texas, United States
Seattle Children's Hospital Research Foundation, Seattle, Washington, United States
The Children's Hospital at Westmead, Westmead, New South Wales, Australia
Royal Children's Hospital, Parkville, Victoria, Australia
The Hospital for Sick Children, Toronto, Ontario, Canada
Rigshospitalet, Copenhagen, , Denmark
Gustave Roussy, Villejuif Cedex, , France
Universitätsklinikum Heidelberg, Heidelberg, Baden-Württemberg, Germany
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Lombardia, Italy
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Hiroshima University Hospital, Hiroshima, , Japan
Kyoto University Hospital, Kyoto, , Japan
Seoul National University Hospital, Seoul, Seoul, Korea, Korea, Republic of
Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [Barcelona], Spain
University College Hospital - London, London, Greater London, United Kingdom
Contact Details
Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Affiliation: Eli Lilly and Company
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
