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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 4 to 17 years
• All sexes
• No healthy volunteers
• Child

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Repotrectinib Post-Marketing Surveillance in Pediatric Patients (Age 4 to < 18) With NTRK Fusion-Positive Advanced/Recurrent Solid Tumors in Japan

Conditions

NTRK Fusion-positive Solid Tumors

Being tested

Repotrectinib

Keywords

Repotrectinib; NTRK fusion-positive; cancer

Medical subject headings

Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• RepotrectinibDrug

  As per product label

What is being measured

The primary outcome is the main question the study is designed to answer.

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

   Measured: Up to week 104

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

   Measured: Up to week 104

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

   Measured: Up to week 104

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

   Measured: Up to week 104

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

   Measured: Up to week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted10 Aug 2026
2. Study start20 Nov 2025
3. Primary completion30 Apr 2034 (estimated)
4. Study completion30 Apr 2034 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for NTRK Fusion-positive Solid TumorsStudies of the same condition, open and under way.
• More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.