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NCT02637687 · ClinicalTrials.gov record · last posted 2025-06-22

A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children

Study acronym: SCOUT
StatusActive, Not Recruiting
PhasePhase 1/2
SponsorBayer
Started2015-12-16
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from the ClinicalTrials.gov record
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.

Amendment record 110 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 110 times since 2015-12-18; most recent amendment 2025-06-20. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2023-07-27
Status change Recruiting→Active, Not Recruitingv90
Trial Details
NCT Number NCT02637687
Lead Sponsor Bayer
Conditions Solid Tumors Harboring NTRK Fusion
Enrollment 154 participants
Start Date 2015-12-16
Primary Completion 2024-07-20 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-06-22