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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
View on ClinicalTrials.gov →
NCT07755826
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
Related trials
- Phase II Efficacy Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced NSCLC — Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Repotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain Metastasis — MedSIR
- A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer — Memorial Sloan Kettering Cancer Center
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Actively Recruiting
SponsorBristol-Myers Squibb
Started2025-11-20
Est. completion2034-04-30
Eligibility
Age4 Years – 17 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07755826