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New drug shows promise for rare joint tumor in early trial

NCT ID NCT03069469

Disease control Sponsor: Deciphera Pharmaceuticals, LLC 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called vimseltinib in people with a rare joint tumor (tenosynovial giant cell tumor, or TGCT) and advanced solid tumors. The drug blocks a protein that helps these tumors grow. The trial has two phases: first, finding the safest dose, then expanding to see how well it shrinks tumors and improves symptoms like pain and joint movement. About 120 adults are taking part.

What this could mean

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

Active substance
vimseltinib (a drug that blocks a protein called CSF1R, which helps control certain tumor growth)
What this could lead to
If successful, this could provide a new treatment option for people with tenosynovial giant cell tumor (TGCT) that cannot be removed by surgery, potentially shrinking tumors and improving joint movement.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not work as hoped or could cause side effects. Results may not apply to all patients.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 120 people

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

Started

Feb 2017

Expected to finish

Aug 2028

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.

Ages

18 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 Dose Escalation Phase: 1. Patients ≥18 years of age 2. Patients must have: 1. advanced malignant solid tumors; or 2. symptomatic TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening) 3. Malignant solid tumor patients only: Able to provide a tumor tissue sample 4. Must have 1 measurable lesion according to RECIST Version 1.1 5. Malignant solid tumor patients only: Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 6. Adequate organ and bone marrow function 7. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements. 8. Must provide signed consent to participate in the study and is willing to comply with study-specific procedures. Expansion Phase (Cohorts A and B) 1. Patients ≥18 years of age 2. Patients must have symptomatic TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening) a) Expansion Cohort B: patients must have prior systemic treatment with anti-CSF1 or anti-CSF1R therapy, with the exception of imatinib or nilotinib 3. Adequate organ and bone marrow function 4. Must have at least 1 measurable lesion according to RECIST Version 1.1 5. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements. 6. Must provide signed consent to participate in the study and is willing to comply with study-specific procedures. Exclusion Criteria Dose Escalation Phase: 1. Received anticancer therapy or therapy for TGCT, including investigational therapy, within 2 weeks or 28 days for therapies with half-life (t1/2) longer than 3 days prior to the administration of study drug. 2. Unresolved toxicity (Grade \>1 or baseline) from previous anticancer therapy or TGCT therapy, excluding alopecia. 3. Known active central nervous system (CNS) metastases. 4. History or presence of clinically relevant cardiovascular abnormalities. 5. Systemic arterial or venous thrombotic or embolic events. 6. QT interval corrected by Fridericia's formula (QTcF) \>450 ms in males or \>470 ms in females or history of long QT syndrome. 7. Left ventricular ejection fraction (LVEF) \<50%. 8. Concurrent treatment with proton-pump inhibitor(s). 9. Major surgery within 2 weeks of the first dose of study drug. 10. Malabsorption syndrome or other illness that could affect oral absorption. 11. Known human immunodeficiency virus, active hepatitis B, active hepatitis C, or active mycobacterium tuberculosis infection. 12. If female, the patient is pregnant or lactating. 13. Known allergy or hypersensitivity to any component of the study drug. 14. Any other clinically significant comorbidities. Expansion Phase (Cohorts A and B) 1. Expansion Cohort A: received systemic therapy targeting CSF1 or CSF1R; previous therapy with imatinib and nilotinib is allowed. 2. Expansion Cohort B: discontinued systemic therapy targeting anti-CSF1 or anti-CSF1R due to drug-induced liver injury. 3. Treatment with therapy for TGCT, including investigational therapy, within 2 weeks or 28 days for therapies with a t1/2 longer than 3 days prior to the administration of the study drug. 4. Known metastatic TGCT or other active cancer that requires concurrent treatment. 5. QT interval corrected by Fridericia's formula (QTcF) \>450 ms in males or \>470 ms in females or history of long QT syndrome. 6. Left ventricular ejection fraction (LVEF) \<55%. 7. Concurrent treatment with proton-pump inhibitor(s). 8. Major surgery within 2 weeks of the first dose of study drug. 9. Any clinically significant comorbidities 10. Malabsorption syndrome or other illness that could affect oral absorption. 11. Known human immunodeficiency virus (HIV), active or chronic hepatitis B, active or chronic hepatitis C, or active mycobacterium tuberculosis infection. 12. If female, the patient is pregnant or lactating. 13. Known allergy or hypersensitivity to any component of the study drug. 14. Contraindication for MRI 15. Active liver or biliary disease, including evidence of fatty liver, nonalcoholic steatohepatitis (NASH), or cirrhosis

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Conditions

The condition(s) this trial relates to.

cancer 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.

Advanced malignant neoplasm Giant cell tumor of tendon sheath Pigmented villonodular synovitis Tenosynovial giant cell tumor Tenosynovial giant cell tumor, diffuse

Contacts and locations

Locations

  • Centre Leon Berard

    Lyon, France

  • Dana Farber

    Boston, Massachusetts, 02215, United States

  • Fondazione IRCCS Istituto Nazionale Dei Tumori

    Milan, Italy

  • Gustave Roussy Cancer Campus Grand Paris

    Paris, France

  • Hospital Clinico San Carlos

    Madrid, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, Spain

  • Hospital Universitario Virgen del Rocío, Sevilla

    Seville, Spain

  • IRCCS Istituto Ortopedico Rizzoli

    Bologna, Italy

  • Istituto Nazionale dei Tumori

    Milan, Italy

  • Leiden University Medical Center

    Leiden, Netherlands

  • M. Sklodowska-Curie Memorial Cancer Center

    Warsaw, Poland

  • MSKCC

    New York, New York, 10065, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • McGill University Health Centre

    Montreal, Quebec, Canada

  • OHSU

    Portland, Oregon, 97239, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Peter MacCallum Cancer Centre

    Melbourne, Australia

  • Princess Margaret Cancer Center

    Toronto, Canada

  • Regina Elena National Cancer Institute

    Rome, Italy

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Stanford Cancer Institute

    Palo Alto, California, 94304, United States

  • University College Hospital

    London, United Kingdom

  • University of Colorado - Denver

    Denver, Colorado, 80204, United States

  • University of Miami

    Miami, Florida, 33136, United States

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