check_circleStudy Completed
Solid tumors harboring NTRK fusion
Bayer Identifier:
20810
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
A study to test the safety of the investigational drug selitrectinib in children and adults that may treat cancer
Trial purpose
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.
Key Participants Requirements
Sex
AllAge
1 - N/ATrial summary
Enrollment Goal
81Trial Dates
July 2017 - January 2023Phase
Phase 1Could I Receive a placebo
NoProducts
selitrectinib (LOXO-195, BAY2731954)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | University of Texas MD Anderson Cancer Center | Houston, 77030, United States |
Completed | Stanford Cancer Center | Palo Alto, 94304, United States |
Completed | Massachusetts General Hospital | Boston, 02114-2696, United States |
Completed | Oregon Health and Science University | Portland, 97239, United States |
Completed | UCLA Jonsson Comprehensive Cancer Center | Los Angeles, 90095-1781, United States |
Completed | Dana-Farber Cancer Institute | Boston, 02215, United States |
Completed | St. Jude Children's Research Hospital | Memphis, 38105, United States |
Withdrawn | University of Texas Southwestern Medical Center | Dallas, 75390, United States |
Completed | University of Michigan | Ann Arbor, 48109, United States |
Completed | Children's Hospital of Philadelphia | Philadelphia, 19104, United States |
Completed | Seattle Children's Hospital | Seattle, 98105, United States |
Completed | Sarah Cannon Research Institute | Nashville, 37203, United States |
Withdrawn | University of Texas Southwestern Medical Center | Dallas, 75390, United States |
Completed | Virginia Oncology Associates | Norfolk, 23502, United States |
Completed | Univ.of California-San Diego Moores Cancer Center | La Jolla, 92093, United States |
Withdrawn | Ochsner Medical Center - New Orleans | New Orleans, 70121, United States |
Completed | Midwestern Regional Medical Center | Zion, 60099, United States |
Withdrawn | Eastern Regional Medical Center | Philadelphia, 19124, United States |
Withdrawn | Sarah Cannon Research Institute at HealthONE | Denver, 80218, United States |
Withdrawn | University of Utah - Oncology | Salt Lake City, 84112, United States |
Completed | Fondazione IRCCS Istituto Nazionale dei Tumori | Milano, 20133, Italy |
Completed | Institut Curie - Ulm - Paris | PARIS cedex 5, 75248, France |
Completed | Institut Gustave Roussy - Département de Médecine Oncologique | VILLEJUIF CEDEX, 94805, France |
Completed | Rigshospitalet - Kræftbehandling | Copenhagen, 2100, Denmark |
Completed | Universitätsklinikum Heidelberg | Heidelberg, 69115, Germany |
Withdrawn | Ciutat Sanitaria i Universitaria de la Vall d'Hebron | Barcelona, 08035, Spain |
Completed | Ciutat Sanitaria i Universitaria de la Vall d'Hebron | Barcelona, 08035, Spain |
Completed | Fundacion Jimenez Diaz (Clinica de la Concepcion) | Madrid, 28040, Spain |
Withdrawn | Austin Health | Heidelberg, 3084, Australia |
Withdrawn | Sarah Cannon Research Institute UK Ltd | London, W1G 6AD, United Kingdom |
Completed | Sydney Children’s Hospital | Sydney, 2031, Australia |
Withdrawn | Seoul National University Hospital | Seoul, 3080, Korea,_republic_of |
Completed | National Cancer Center Singapore | Singapore, 168583, Singapore |
Withdrawn | Prince of Wales Hospital | Hong Kong, MISSING, Hong Kong |
Completed | Avera Cancer Institute | Sioux Falls, 57105, United States |
Withdrawn | CHU Sainte-Justine | Montreal, H3T 1C5, Canada |
Completed | UZ Antwerpen | EDEGEM, 2650, Belgium |
Completed | Tallaght Hospital | Dublin, D24NR0A, Ireland |
Withdrawn | McGill University Health Center | Montreal, H3A 2B4, Canada |
Withdrawn | KK Women's and Children's Hospital | Singapore, 229899, Singapore |
Completed | Children's Healthcare of Atlanta | Atlanta, 30322, United States |
Withdrawn | Beijing Cancer Hospital | Beijing, 100142, China |
Withdrawn | Zhongshan Hospital, Fudan University | Shanghai, 200032, China |
Withdrawn | Zhejiang Cancer Hospital | Hangzhou, 310022, China |
Withdrawn | West China Hospital Sichuan University | Chengdu, 610041, China |
Completed | Royal Children's Hospital Melbourne | Parkville, 3052, Australia |
Withdrawn | Charité Comprehensive Cancer Center (CCCC) | Berlin, 12203, Germany |
Withdrawn | Duke University Medical Center | Durham, 27710, United States |
Withdrawn | University of Wisconsin - Madison | Madison, 53792, United States |
Withdrawn | University Hospitals Cleveland Medical Center | Cleveland, 44106, United States |
Withdrawn | Levine Cancer Institute | Charlotte, 28204-2990, United States |
Withdrawn | UCSF Med Center Helen Diller Family Comp Cancer Center | San Francisco, 94158, United States |
Withdrawn | Institut Bergonié - Unicancer Nouvelle Aquitaine | BORDEAUX CEDEX, 33076, France |
Withdrawn | Sunnybrook Health Sciences Centre | Toronto, M4N 3M5, Canada |
Withdrawn | Christie Hospital | Manchester, M20 4BX, United Kingdom |
Withdrawn | Hong Kong United Oncology Centre | Kowloon, Hong Kong |
Completed | Memorial Sloan-Kettering Cancer Center | New York, 10065, United States |
Primary Outcome
- Maximum tolerated dose (MTD)date_rangeTime Frame:Up to 42 days
- Recommended dosedate_rangeTime Frame:Up to 12 months
Secondary Outcome
- Incidence of adverse eventsdate_rangeTime Frame:Up to 56 months
- Severity of adverse eventsSeverity is assessed using CTCAE version 4.03date_rangeTime Frame:Up to 56 months
- Duration of adverse eventsdate_rangeTime Frame:Up to 56 months
- Number of subjects with safety-relevant changes in clinical parameters or vital signs after drug administrationdate_rangeTime Frame:Up to 56 months
- Severity of safety-relevant changes in clinical parameters or vital signs after drug administrationdate_rangeTime Frame:Up to 56 months
- Overall response rate (ORR) in subjects with NTRK fusion cancer previously treated with TRK inhibitor determined by investigatorORR is determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.date_rangeTime Frame:Up to 56 months
- Overall response rate (ORR) in subjects with primary central nervous system (CNS) malignancies determined by investigatorORR is determined by the treating investigator using the Response Assessment in Neuro-Oncology (RANO) criteria.date_rangeTime Frame:Up to 56 months
- Maximum concentration (Cmax) of BAY2731954 in plasmadate_rangeTime Frame:Predose, 0.25, 0.5, 1, 2, 4, 6, 8 hours post-dose on Day 1, predose, 0.5, 1, 2, 4 post-dose on Day 8 of Cycle 1 (cycle length 28 days)
- Area under the concentration versus time curve of BAY2731954 in plasma (AUC (0-10), AUC(0-12) for BID dosing and AUC(0-24) for QD dosing)date_rangeTime Frame:At defined time points for different cohort, up to 10 hours post-dose
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
N/AAssignment
Sequential AssignmentTrial Arms
2