Solid Tumors Harboring NTRK Fusion Clinical Trial
Official title:
An Open-label, Non-randomized, Phase I Study to Evaluate the Pharmacokinetics of Selitrectinib (BAY 2731954) and Food Effects in Healthy Adult Male Participants
The researchers in this study want to gather information in healthy adult male participants about how the human body absorbs, distributes and excretes the drug selitrectinib including the effect of the interaction of food with the study drug on the human body. Selitrectinib is a new drug under development for the treatment of patients with solid tumor caused by a genetic abnormality known as an NTRK gene fusion which cannot be cured by currently available treatment options or has spread to other parts of the body. The drug blocks the action of the NTRK gene fusion and prevents the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. Researchers also want to find out if the participants have any medical problems during this study. Participants in this study will receive the study drug twice with at least 6 days in between. The study drug will be taken orally as a liquid before or after meal. Observation will last for up to 8 weeks, and blood samples will be taken from the participants to measure the blood levels of the study drug.
The primary objectives of this study are to investigate the pharmacokinetics and the effect of food on the pharmacokinetics of selitrectinib after a single dose of the drug. Secondary objective is to assess the safety of selitrectinib after a single dose. ;
| 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 |
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
|