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Can a targeted drug be safely used in children with rare tumors?

NCT ID NCT07755826

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This study monitors the safety of repotrectinib, a targeted cancer drug, in children and adolescents aged 4 to under 18 with NTRK fusion-positive advanced or recurrent solid tumors. Researchers will track side effects during routine treatment, paying special attention to nervous system issues, lung problems, and fractures. The goal is to better understand the drug's safety profile in this younger population.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
repotrectinib
What this could lead to
If successful, this study could provide reassurance about the safety of repotrectinib in children, supporting its use as a treatment option for NTRK fusion-positive tumors.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove effectiveness. Side effects may still occur, and the small number of participants limits generalizability.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Apr 2034

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

4 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

neoplasm NTRK fusion positive cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NTRK fusion-positive solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CMIC Co., Ltd.

    RECRUITING

    Minato-ku, Tokyo, 105-0023, Japan

  • EPS Corporation

    RECRUITING

    Tokyo, Japan