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A Study to Test the Safety of the Investigational Drug Selitrectinib in Children and Adults That May Treat Cancer

NCT03215511 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2024-10-30

No results posted yet for this study

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.

Conditions

  • Solid Tumors Harboring NTRK Fusion

Interventions

DRUG

Selitrectinib (BAY2731954)

Selitrectinib is administered as capsules or liquid formulation.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-03
Primary Completion
2022-04-11
Completion
2023-01-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Denmark
  • France
  • Germany
  • Ireland
  • Italy
  • Singapore
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03215511 on ClinicalTrials.gov