NCT02637687: SCOUT

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

Active, enrolled Phase 1, PHASE2 Last updated 22 June 2025

What this trial tests

Phase 1, PHASE2 trial testing Larotrectinib (Vitrakvi, BAY2757556) in Solid Tumors Harboring NTRK Fusion in 154 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

16 December 2015

Primary endpoint
20 July 2024

30 September 2026

Quick facts

Lead sponsor	Bayer
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	154
Start date	16 December 2015
Primary completion	20 July 2024
Estimated completion	30 September 2026
Sites	45 locations across Italy, Japan, Ireland, Poland, South Korea, Denmark, Netherlands, Sweden

Drugs / interventions tested

• Larotrectinib (Vitrakvi, BAY2757556) — full drug profile →

Conditions studied

• Solid Tumors Harboring NTRK Fusion — all drugs for Solid Tumors Harboring NTRK Fusion →

Sponsor

Bayer — full company profile →

Who can join

Under 21, any sex, with Solid Tumors Harboring NTRK Fusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy of Larotrectinib in TRK Fusion-Positive Cancers in Adults and Children.
   Drilon A, Laetsch TW, Kummar S, DuBois SG, et al · · 2018 · cited 1987× · PMID 29466156 · DOI 10.1056/nejmoa1714448
2. NTRK fusion-positive cancers and TRK inhibitor therapy.
   Cocco E, Scaltriti M, Drilon A. · · 2018 · cited 1049× · PMID 30333516 · DOI 10.1038/s41571-018-0113-0
3. Larotrectinib in patients with TRK fusion-positive solid tumours: a pooled analysis of three phase 1/2 clinical trials.
   Hong DS, DuBois SG, Kummar S, Farago AF, et al · · 2020 · cited 730× · PMID 32105622 · DOI 10.1016/s1470-2045(19)30856-3
4. Larotrectinib for paediatric solid tumours harbouring NTRK gene fusions: phase 1 results from a multicentre, open-label, phase 1/2 study.
   Laetsch TW, DuBois SG, Mascarenhas L, Turpin B, et al · · 2018 · cited 425× · PMID 29606586 · DOI 10.1016/s1470-2045(18)30119-0
5. <i>NTRK</i> gene fusions as novel targets of cancer therapy across multiple tumour types.
   Amatu A, Sartore-Bianchi A, Siena S. · · 2016 · cited 423× · PMID 27843590 · DOI 10.1136/esmoopen-2015-000023
6. Clinical and analytical validation of FoundationOne®CDx, a comprehensive genomic profiling assay for solid tumors.
   Milbury CA, Creeden J, Yip WK, Smith DL, et al · · 2022 · cited 292× · PMID 35294956 · DOI 10.1371/journal.pone.0264138
7. Pediatric low-grade glioma in the era of molecular diagnostics.
   Ryall S, Tabori U, Hawkins C. · · 2020 · cited 254× · PMID 32164789 · DOI 10.1186/s40478-020-00902-z
8. The molecular biology of pancreatic adenocarcinoma: translational challenges and clinical perspectives.
   Wang S, Zheng Y, Yang F, Zhu L, et al · · 2021 · cited 252× · PMID 34219130 · DOI 10.1038/s41392-021-00659-4