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

NCT07755826 | Recruiting FDA Drug

• 1 other identifier: CA127-1067
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

NTRK Fusion-positive Solid Tumors

Keywords

Repotrectinib; NTRK fusion-positive; cancer

Outcome Measures

Primary Outcomes (5)

• Number of participants with 1 or more adverse events (AEs)

  Up to week 104

• Number of participants with 1 or more serious adverse events (SAEs)

  Up to week 104

• Number of participants with adverse events by system organ class (including central nervous system disorders, interstitial lung disease, and fractures)

  Up to week 104

• Number of participants with adverse events (AEs) leading to treatment modification (interruption, dose reduction, or discontinuation)

  Up to week 104

• Number of participants with each adverse event outcome category (resolved, resolving, not resolved, resolved with sequelae, death, unknown)

  Up to week 104

Study Arms (1)

Group 1

Pediatric participants with NTRK fusion-positive advanced or recurrent solid tumors treated with repotrectinib

Drug: Repotrectinib

Interventions

Repotrectinib DRUG

As per product label

Group 1

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include pediatric participants in Japan with NTRK fusion-positive advanced or recurrent solid tumors that have initiated repotrectinib.

You may qualify if:

• 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.

You may not qualify if:

• Participants receiving repotrectinib for an off-label indication

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

CMIC Co., Ltd.

Minato-ku, Tokyo, 105-0023, Japan

RECRUITING

EPS Corporation

Tokyo, Japan

RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Neoplasms

Interventions

repotrectinib

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: November 20, 2025
• Primary Completion (Estimated): April 30, 2034
• Study Completion (Estimated): April 30, 2034
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)