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Leukemia drug shows promise against rare joint tumors

NCT ID NCT01207492

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 nilotinib, a drug originally used for leukemia, in 17 patients with relapsed or metastatic pigmented villonodular synovitis (PVNS) or related giant cell tumors. The goal was to see if the drug could stop tumor growth or improve symptoms. Results focused on how long patients lived without their disease getting worse.

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

17 people

The number who actually took part.

Started

Sep 2010

Finished

Aug 2015

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Histologically confirmed diagnosis of recurrent PVNS ( or diffuse-type giant cell tumor or tenosynovial giant cell tumor) that is unresectable, metastatic, or for which the patient refuses surgical intervention * Progressive disease in the last 12 months, as demonstrated by imaging or clinical appearance of new tumors, in the opinion of the treating investigator * At least one site of measurable disease according to RECIST 1.1 on MRI (or CT scan for metastatic disease) * Any number or type of prior systemic therapies, with the exception of known or suspected CSF1 receptor inhibitors as outlined in exclusion criteria below * 18 years of age or older * Life expectancy greater than 6 months * ECOG Performance Status of 0, 1 or 2 * Normal organ and marrow function as defined in the protocol * QTc less than or equal to 450 ms on 12-lead ECG * Negative urine or serum pregnancy test within days of start of study drug administration for women of childbearing potential. * Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 3 months following study drug discontinuation Exclusion Criteria: * Prior treatment with known or suspected CSF1 receptor inhibitor, including nilotinib, imatinib, sunitinib, or sorafenib, or other approved or investigational tyrosine kinase inhibitors used for treatment of diffuse-type giant cell tumor * Concurrent treatment with other investigational agents * Inability to tolerate or contraindication to MRI scanning for participants with localized disease * Impaired cardiac function * Current treatment with strong CYP3A4 inhibitors that cannot either be discontinued or switched to a different medication prior to starting study drug * Current treatment with any medications that have the potential to prolong the QT interval and that cannot either be discontinued or switched to a different medication prior to starting study drug * Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug * Acute or chronic pancreatic disease * Acute or chronic liver disease * Another primary malignant disease requiring systemic treatment or radiation * History of significant congenital or acquired bleeding disorder unrelated to cancer * Major surgery within 28 days prior to Day 1 of the study * Treatment with other investigational agents within 28 days of day 1 * History of non-compliance to medical regimens or inability to grant consent * Women who are pregnant or breastfeeding * Other comorbidities that would interfere with study participation or safety in the opinion of the investigator

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Sarcoma Oncology Center

    Santa Monica, California, 90403, United States

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.