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Clinical Trial Summary

The study is being done to test the safety of a cancer drug called larotrectinib in children. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. The first study part (Phase 1) is done to determine what dose level of larotrectinib is safe for children, how the drug is absorbed and changed by their bodies and how well the cancer responds to the drug. The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with larotrectininb.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Neoplasms
  • Solid Tumors Harboring NTRK Fusion

NCT number NCT02637687
Study type Interventional
Source Bayer
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date December 16, 2015
Completion date September 22, 2026

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 NCT03215511 - A Study to Test the Safety of the Investigational Drug Selitrectinib in Children and 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
No longer available NCT03206931 - Expanded Access to Provide Selitrectinib for the Treatment of Cancers With a NTRK Gene Fusion