Sponsor study identifier
Secondary identifiers
interventional
81
10 countries
29
Study Start
July 3, 2017
Actual (reported)Primary Completion
April 11, 2022
Actual (reported)Study Completion
January 30, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 30, 2017
Actual (reported)July 3, 2017
Actual (reported)July 12, 2017
Actual (reported)April 11, 2022
Actual (reported)January 30, 2023
Actual (reported)Maximum tolerated dose (MTD)
Up to 42 days
Recommended dose
Up to 12 months
Incidence of adverse events
Up to 56 months
Severity of adverse events
Up to 56 months
Duration of adverse events
Up to 56 months
Number of subjects with safety-relevant changes in clinical parameters or vital signs after drug administration
Up to 56 months
Severity of safety-relevant changes in clinical parameters or vital signs after drug administration
Up to 56 months
A Rolling-6 dose escalation design will be used. The starting dose for participants age \< 12 years will be 25% below the highest dose level cohort divided by 1.73 m\^2 cleared by the Safety Review Committee (SRC) for subjects age 12 years and older.
A 3+3 dose escalation design will be used to determine the maximum tolerated dose (MTD)/recommended dose for further study, enrolling 3 to 6 participants per cohort with a starting dose level of 100 mg twice daily (BID).
Selitrectinib is administered as capsules or liquid formulation.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Univ.of California-San Diego Moores Cancer Center
La Jolla, California, 92093, United States
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095-1781, United States
Stanford Cancer Center
Palo Alto, California, 94304, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Midwestern Regional Medical Center
Zion, Illinois, 60099, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696, United States
Dana-Farber Cancer Institute
O'Reilly EM, Hechtman JF. Tumour response to TRK inhibition in a patient with pancreatic adenocarcinoma harbouring an NTRK gene fusion. Ann Oncol. 2019 Nov 1;30(Suppl_8):viii36-viii40. doi: 10.1093/annonc/mdz385. Epub 2019 Dec 24.
81 participants (actual enrollment reported by the registry).
First Submitted
June 30, 2017
First Posted
July 12, 2017
Study Start
July 3, 2017
Actual (reported)Contact the study team to confirm eligibility.
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Sydney Children's Hospital
Sydney, New South Wales, 2031, Australia
Royal Children's Hospital Melbourne
Parkville, Victoria, 3052, Australia
UZ Antwerpen
Edegem, 2650, Belgium
Rigshospitalet - Kræftbehandling
Copenhagen, 2100, Denmark
Institut Curie - Ulm - Paris
Paris, 75248, France
Institut Gustave Roussy - Département de Médecine Oncologique
Villejuif, 94805, France
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69115, Germany
Tallaght Hospital
Dublin, D24NR0A, Ireland
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20133, Italy
National Cancer Center Singapore
Singapore, 168583, Singapore
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
Barcelona, 08035, Spain
Fundacion Jimenez Diaz (Clinica de la Concepcion)
Madrid, 28040, Spain
Primary Completion
April 11, 2022
Actual (reported)Study Completion
January 30, 2023
Actual (reported)Last Updated
October 30, 2024
Record last verified: 2024-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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