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Repotrectinib Post-Marketing Surveillance in Pediatric Patients With NTRK Fusion-Positive Tumors in Japan
Repotrectinib Post-Marketing Surveillance in Pediatric Patients With NTRK Fusion-Positive Tumors in Japan
RecruitingN/A
Sponsor: Bristol-Myers Squibb
Conditions: NTRK Fusion-positive Solid Tumors
Interventions: Repotrectinib
Countries: 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.
Eligibility overview
Sex: ALL
Age: 4 Years to 17 Years
Healthy volunteers: No
Study type: OBSERVATIONAL
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
Locations (2)
- Minato-ku, Tokyo, Japan
- Tokyo, Japan