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New drug hope for rare joint tumor patients who Can't have surgery

NCT ID NCT04703322

Disease control Sponsor: Daiichi Sankyo Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called pexidartinib (TURALIO) in 9 Japanese adults with tenosynovial giant cell tumor (TGCT), a rare, non-cancerous growth in the joints that causes pain and limits movement. The goal was to see if the drug is safe and can shrink tumors in people whose tumors are too severe or risky to remove with surgery. Participants took 800 mg of pexidartinib daily, and researchers measured tumor response using MRI scans.

What this could mean

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

Active substance
pexidartinib (TURALIO)
What this could lead to
If successful, this could provide a non-surgical treatment option for people with TGCT who have severe symptoms and cannot have surgery.
What could go wrong
This is a small, early-phase study with only 9 participants, so results may not apply to everyone. Pexidartinib can cause serious side effects, including liver injury.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

9 people

The number who actually took part.

Started

Mar 2021

Finished

May 2026

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.

Ages

20 years and older

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: * Age ≥20 years * A diagnosis of TGCT (i) that has been histologically confirmed by a pathologist1 and (ii) associated with severe morbidity or functional limitations and not amenable to improvement with surgery determined consensually by qualified personnel (eg, 2 surgeons or a multi-disciplinary tumor board). * Measurable disease as defined by RECIST version 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scan by a central radiologist. Exclusion Criteria: * Known metastatic TGCT. * Pre-existing increased serum transaminases; total bilirubin or direct bilirubin (\>upper limit of normal); or active liver or biliary tract disease, including increased alkaline phosphatase. * Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history that, in the Investigator's opinion, would likely interfere with a participant's study participation or the interpretation of his or her results. * Use of strong cytochrome P450 3A inducers, including St John's wort, proton pump inhibitors and potassium-competitive acid blockers, or other products known to cause hepatotoxicity.

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Conditions

The condition(s) this trial relates to.

Giant Cell Tumor of Tendon Sheath tenosynovial giant cell tumor tenosynovial giant cell tumor, diffuse type

As listed by the trial registrant

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

Tenosynovial giant cell tumor

Contacts and locations

Locations

  • Kanazawa University Hospital

    Ishikawa, 920-8641, Japan

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • Nagoya University Hospital

    Aichi, 466-8560, Japan

  • National Cancer Center Hospital

    Tokyo, 104-0045, Japan

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006, Japan

  • Osaka International Cancer Institute

    Osaka, 541-8567, Japan

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