Status:
ACTIVE_NOT_RECRUITING
Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor
Lead Sponsor:
Andrew J. Wagner, MD, PhD
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Pigmented Villonodular Synovitis
Diffuse-type Giant Cell Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
* In this research study, each cycle of study drug dosing will last 4 weeks (28 days). During each cycle, participants will take nilotinib by mouth twice daily. During the first cycle, participants wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01207492
Start Date
September 1 2010
End Date
July 1 2026
Last Update
July 17 2025
Active Locations (7)
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1
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
2
Stanford University Medical Center
Stanford, California, United States, 94305
3
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114