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

August 5, 2026 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Japan
      • Tokyo, Japan
        • Recruiting
        • EPS Corporation
    • Tokyo
      • Minato-ku, Tokyo, Japan, 105-0023
        • Recruiting
        • CMIC Co., Ltd.
        • Contact:
          • Eri Yoshida, Site 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include pediatric participants in Japan with NTRK fusion-positive advanced or recurrent solid tumors that have initiated repotrectinib.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Pediatric participants with NTRK fusion-positive advanced or recurrent solid tumors treated with repotrectinib
Drug: Repotrectinib
As per product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with 1 or more adverse events (AEs)
Time Frame: Up to week 104
Up to week 104
Number of participants with 1 or more serious adverse events (SAEs)
Time Frame: Up to week 104
Up to week 104
Number of participants with adverse events by system organ class (including central nervous system disorders, interstitial lung disease, and fractures)
Time Frame: Up to week 104
Up to week 104
Number of participants with adverse events (AEs) leading to treatment modification (interruption, dose reduction, or discontinuation)
Time Frame: Up to week 104
Up to week 104
Number of participants with each adverse event outcome category (resolved, resolving, not resolved, resolved with sequelae, death, unknown)
Time Frame: Up to week 104
Up to week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2025

Primary Completion (Estimated)

April 30, 2034

Study Completion (Estimated)

April 30, 2034

Study Registration Dates

First Submitted

August 5, 2026

First Submitted That Met QC Criteria

August 5, 2026

First Posted (Actual)

August 10, 2026

Study Record Updates

Last Update Posted (Actual)

August 10, 2026

Last Update Submitted That Met QC Criteria

August 5, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA127-1067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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