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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Solid Tumors Harboring NTRK Fusion

NCT number NCT03215511
Study type Interventional
Source Bayer
Contact
Status Completed
Phase Phase 1
Start date July 3, 2017
Completion date January 30, 2023

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02576431 - A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors Phase 2
Completed NCT02122913 - A Study to Test the Safety of the Investigational Drug Larotrectinib in Adults That May Treat Cancer Phase 1
Completed NCT04275960 - Study in Healthy Adult Male Participants to Gather Information How the Human Body Absorbs, Distributes and Excretes the Study Drug Selitrectinib Including the Effect of the Interaction of Food With the Study Drug on the Human Body Phase 1
Completed NCT04771390 - Study to Compare How the Body Absorbs, Distributes and Excretes the Drug Selitrectinib (BAY2731954) Given as Two Different Tablet Formulations or as Liquid Formulations Including the Effect of Food on the Absorption, Distribution or Excretion of the Different Formulations in Healthy Participants Phase 1
Completed NCT05192642 - A Study Called VICTORIA to Learn More About How Well Larotrectinib Works in Adults With TRK Fusion-positive Cancer by Comparing Larotrectinib Data From Clinical Studies With Data of Other Treatments From Actual Practice
Active, not recruiting NCT02637687 - A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children Phase 1/Phase 2
No longer available NCT03206931 - Expanded Access to Provide Selitrectinib for the Treatment of Cancers With a NTRK Gene Fusion