Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NTRK Fusion-positive Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Repotrectinib | Drug | Repotrectinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- description
- Pediatric participants with NTRK fusion-positive advanced or recurrent solid tumors treated with repotrectinib
- interventionNames
- Drug: Repotrectinib
Primary outcomes (5)
- measure
- Number of participants with 1 or more adverse events (AEs)
- timeFrame
- Up to week 104
- measure
- Number of participants with 1 or more serious adverse events (SAEs)
- timeFrame
- Up to week 104
- measure
- Number of participants with adverse events by system organ class (including central nervous system disorders, interstitial lung disease, and fractures)
- timeFrame
- Up to week 104
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available