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

RECRUITINGSponsored by Bristol-Myers Squibb
Actively Recruiting
SponsorBristol-Myers Squibb
Started2025-11-20
Est. completion2034-04-30
Eligibility
Age4 Years – 17 Years
Healthy vol.Accepted

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.

Eligibility

Age: 4 Years – 17 YearsHealthy volunteers accepted
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

Conditions2

CancerNTRK Fusion-positive Solid Tumors

Interventions1

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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