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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07755826

Enrollment

Registered

2026-08-10

Start date

2025-11-20

Completion date

2034-04-30

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NTRK Fusion-positive Solid Tumors

Keywords

Repotrectinib; NTRK fusion-positive; cancer

Brief summary

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.

Interventions

DRUGRepotrectinib

As per product label

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

4 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Japan

Contacts

CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Clinical.Trials@bms.com855-907-3286

CONTACTFirst line of the email MUST contain NCT # and Site #.

STUDY_DIRECTORBristol Myers Squibb

Bristol-Myers Squibb

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026