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Clinical trial Recruiting at 2 sites Observational Ages 4 to 17

Repotrectinib safety in children with NTRK fusion cancers in Japan

Official title: Repotrectinib Post-Marketing Surveillance in Pediatric Patients (Age 4 to < 18) With NTRK Fusion-Positive Advanced/Recurrent Solid Tumors in Japan

Run by Bristol-Myers Squibb · NCT07755826 · Data updated 2026-11-12

This study tests the safety of repotrectinib in children and teens with NTRK fusion–positive solid tumors in Japan during routine care.

Quick facts

Study typeObservational
Ages4 Years to 17 Years
SexAll
Enrollment20 (estimated)
SponsorBristol-Myers Squibb
Industry-sponsored
Drugs / interventionsRepotrectinib
Locations2 sites (Minato-ku, Tokyo and 1 other locations)
StatusRecruiting
StartedNovember 20, 2025
Main results expectedApril 30, 2034
Study endsApril 30, 2034
Registry record updatedAugust 10, 2026
Trial IDNCT07755826 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are pediatric patients (ages 4 to <18) with NTRK fusion–positive advanced or recurrent solid tumors who are being treated with repotrectinib at participating Japanese institutions.

Probably not a fit

Patients without NTRK fusions or those not receiving repotrectinib for approved indications may not experience safety-related benefits from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational post-marketing study in Japanese pediatric patients aged 4 to under 18 who have NTRK fusion–positive advanced or recurrent solid tumors and are treated with repotrectinib. It collects real-world safety data, focusing on adverse events including central nervous system disorders, interstitial lung disease, and fractures. Recruitment spans six years after the drug’s approval in Japan, across participating institutions. The study does not randomize treatments or compare to a control group and will describe safety signals in this population.

Why it matters

Potential benefit: If successful, the study could clarify the safety profile of repotrectinib in pediatric patients and help clinicians manage potential side effects.

How similar studies have gone: Previous reports in adults and other settings suggest a manageable safety profile for repotrectinib; pediatric-specific data are limited, making this study valuable but exploratory.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* All pediatric NTRK fusion-positive, advanced or recurrent solid tumors patients (age 4 to \< 18) who received Repotrectinib for the approved indications at medical institutions in Japan during enrollment period (for 6 years after approval for this application) will be enrolled in this Post-Marketing Study.

Exclusion Criteria:

* Participants receiving repotrectinib for an off-label indication

Where it's running

  • CMIC Co., Ltd.
    Minato-ku, Tokyo, Japan     Recruiting
  • EPS Corporation
    Tokyo, Japan     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.