Repotrectinib Post-Marketing Surveillance in Pediatric Patients With NTRK Fusion-Positive Tumors in Japan

Conditions

• NTRK Fusion-positive Solid Tumors

Eligibility Criteria

Sex

ALL

Age

4 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Repotrectinib — DRUG
  As per product label

Study Details

This study will collect safety information during routine medical care for children and adolescents in Japan who have been diagnosed with NTRK fusion-positive advanced or recurrent solid tumors who start treatment with repotrectinib. The study will describe how often side effects occur during treatment, with special attention to central nervous system disorders, interstitial lung disease, and fractures.

Key Dates

First listed

Aug 10, 2026

Start date

Nov 20, 2025

Status verified

Aug 2026

Primary completion

Apr 30, 2034

Completion

Apr 30, 2034

Study Design

Enrollment

20 participants (estimated)

Arms

• Arm: Group 1
  Pediatric participants with NTRK fusion-positive advanced or recurrent solid tumors treated with repotrectinib

Primary Outcome Measure

Number of participants with 1 or more adverse events (AEs) [ Time Frame: Up to week 104 ]

Central Contacts

• BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  855-907-3286
  [email protected]
• First line of the email MUST contain NCT # and Site #.