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Recruiting
NCT07755826
Repotrectinib Post-Marketing Surveillance in Pediatric Patients With NTRK Fusion-Positive Tumors in Japan
Conditions: NTRK Fusion-positive Solid Tumors
Sex: All
Ages: 4 Years – 17 Years
Healthy volunteers: No
Enrollment: 20
Sponsor: Bristol-Myers Squibb
Location: CMIC Co., Ltd. Minato-ku Tokyo
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 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
Source: ClinicalTrials.gov (NCT07755826). StuddyBuddy aggregates publicly available trial information.