Spots Global Cancer Trial Database for A Study to Test the Safety of the Investigational Drug Selitrectinib in Children and Adults That May Treat Cancer
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Trial Identification
Brief Title: A Study to Test the Safety of the Investigational Drug Selitrectinib in Children and Adults That May Treat Cancer
Official Title: A Phase 1 Study of the TRK Inhibitor Selitrectinib (BAY 2731954) in Adult and Pediatric Subjects With Previously Treated NTRK Fusion Cancers
Study ID: NCT03215511
Conditions
Interventions
Study Description
Brief Summary: This research study is done to test the safety of the new drug selitrectinib in children and adults with cancer having a change in a particular gene (NTRK1, NTRK2 or NTRK3). The drug may treat cancer by interfering with the effect of the NTRK genes on cancer growth. The study also investigates how the drug is absorbed and processed in the human body, and how well and for how long the cancer responds to the drug. This is the first study to test selitrectinib in humans with cancer, for whom no other effective therapy exists.
Detailed Description: The primary objective is to determine the recommended dose for further study of oral selitrectinib with previously treated neurotrophic tyrosine kinase (NTRK) cancers in 2 patient groups: a) aged 12 years and older and b) younger than 12 years. Secondary objectives of Phase I are to characterize the pharmakokinetic properties of the test drug, its safety and tolerability, and to assess the objective response rate (ORR) of NTRK-tumors.
Eligibility
Minimum Age: 1 Month
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Univ.of California-San Diego Moores Cancer Center, La Jolla, California, United States
UCLA Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
Stanford Cancer Center, Palo Alto, California, United States
Children's Healthcare of Atlanta, Atlanta, Georgia, United States
Midwestern Regional Medical Center, Zion, Illinois, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Oregon Health and Science University, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Seattle Children's Hospital, Seattle, Washington, United States
Sydney Children's Hospital, Sydney, New South Wales, Australia
Royal Children's Hospital Melbourne, Parkville, Victoria, Australia
UZ Antwerpen, Edegem, , Belgium
Finsen Centre, Copenhagen, , Denmark
Institut Curie - Ulm - Paris, Paris, , France
Institut Gustave Roussy - Département de Médecine Oncologique, Villejuif, , France
Universitätsklinikum Heidelberg, Heidelberg, Baden-Württemberg, Germany
Tallaght Hospital, Dublin, , Ireland
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy
National Cancer Center Singapore, Singapore, , Singapore
Ciutat Sanitaria i Universitaria de la Vall d'Hebron, Barcelona, , Spain
Fundacion Jimenez Diaz (Clinica de la Concepcion), Madrid, , Spain
Contact Details
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