Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 2

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

17 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

Nilotinib is a drug that is used to treat a form of a blood cancer called leukemia. Nilotinib works by blocking the action of a protein that might be important for the growth of pigmented villonodular synovitis (PVNS). In this research study the investigators are testing whether nilotinib can stop the growth of PVNS or improve the symptoms experienced from PVNS.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (7)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

7 locations

Study team and timeline

Lead sponsor

Andrew J. Wagner, MD, PhD

Study start

2010-09 Actual

Primary completion

2014-04 Actual

Study completion

2015-08 Actual

First posted

Sep 23, 2010 Estimated

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.