Phase II study of nilotinib efficacy in pigmented villo-nodular synovitis/tenosynovial giant cell tumor (PVNS/TGCT)
- Conditions
- Pigmented Villonodulair Synovitis (PVNS) Giant Cell Tumor of Tendon10013361
- Registration Number
- NL-OMON36562
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
Patients will be included in the study if they meet all the following inclusion criteria:
1. Age >= 18 years
2. Histologically confirmed diagnosis of inoperable progressive or relapsing PVNS/TGCT OR resectable tumor requesting mutilating surgery
3. Demonstrated progressive disease in the last 12 months
4. At least one measurable site of disease on CT/MRI scan according to RECIST criteria based on investigator*s assessment
5. WHO Performance status of 0, 1 or 2
6. Adequate organ, electrolyte and marrow function, defined as the following: serum bilirubin <=1.5 x ULN, ALT and AST <=2.5 x ULN, serum creatinine <=1.5 x ULN or 24 hour creatinine clearance >=50 mL/min, absolute neutrophil count (ANC) >=1.5x109/L, platelets >=100x109/L
7. Prior physical examination adapted to the research
8. Signed written informed consent form
9. Covered by a medical insurance organism (in countries where applicable)
Patients will not be included in the study if they meet any of the following non-inclusion criteria:
1. Pregnant or lactating female or female of child-bearing potential not employing adequate contraception during the study and for up to three months following termination of the study
2. Hypersensitivity to nilotinib or to any of the excipients
3. Acute or chronic uncontrolled liver disease, or severe renal disease
4. Impaired cardiac function, including: LVEF<45% or below the institutional lower limit of the normal range (whichever is higher) as determined by echocardiogram or MUGA scan; history or signs of prior myocardial infarction; history of unstable angina; other clinically significant heart disease (e.g. congestive heart failure or uncontrolled hypertension)
5. Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol e.g. uncontrolled diabetes, active or uncontrolled infection
6. History of non-compliance to medical regimens
7. Concomitant treatment with medicinal products that induce CYP3A4 (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or St. John*s Wort), or that inhibit the CYP3A4 activity (e.g. ketoconazole, itraconazole, erythromycin, clarithromycin)
8. Concomitant treatment with warfarin
9. Concomitant treatment with medication that prolong the QT interval
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of the study will be to determine the efficacy of 12<br /><br>weeks of nilotinib treatment as measured by the non progression rate (Complete<br /><br>response + Partial Response + Stable disease according to Response Evaluation<br /><br>Criteria In Solid Tumors - RECIST) in patients with progressive or relapsing<br /><br>PVNS/TGCT who cannot be treated by surgery.</p><br>
- Secondary Outcome Measures
Name Time Method