Status:
COMPLETED
Study of Nilotinib Efficacy in Pigmented Villo-Nodular Synovitis/ Tenosynovial Giant Cell Tumour (PVNS/TGCT)
Lead Sponsor:
Centre Leon Berard
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Pigmented Villonodular Synovitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to explore the efficacy of nilotinib as a treatment of patients with progressive or relapsing pigmented villo-nodular synovitis / tenosynovial giant cell tumour (PVNS/TGCT...
Detailed Description
A key secondary objective of the study will be to determine the efficacy of 24 weeks (6 months) of nilotinib treatment as measured by the non progression rate (Complete response + Partial Response + S...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Histologically confirmed diagnosis of inoperable progressive or relapsing PVNS/TGCT OR resectable tumour requesting mutilating surgery
- Demonstrated progressive disease in the last 12 months
- At least one measurable site of disease on MRI/CT scan according to RECIST criteria (RECIST version 1.1) based on investigator's assessment
- WHO Performance status of 0, 1 or 2
- Adequate organ, electrolyte and marrow function, defined as the following: serum bilirubin \> or =1.5 x ULN, ALT and AST \< or = 2.5 x ULN, serum creatinine \< or = 1.5 x ULN or creatinine clearance \> or = 50 mL/min, absolute neutrophil count (ANC) \> or = 1.5x109/L, platelets \> or = 100x109/L, serum lipase \< or =1.5 x ULN, magnesium ≥ lower limit of normal (LLN) and potassium ≥ LLN
- Prior adequate physical examination including weight, height, ECOG PS and vital signs (systolic and diastolic blood pressure, heart rate after at least 5 minutes in supine position)
- Signed written informed consent form
- Covered by a medical insurance (in countries where applicable)
Exclusion
- 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
- Known hypersensitivity to nilotinib or to any of the excipients, galactose intolerance, lactase deficiency or glucose-galactose malabsorption prior to enrollment
- Acute or chronic uncontrolled liver disease, or severe renal disease
- Impaired cardiac function, including:
- LVEF\<50% 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
- Congenital long QT prolongation
- Personal history of unexplained syncope
- QTc interval ≥ 450 msec on screening ECG
- Other clinically significant heart disease (e.g. bradycardia, congestive heart failure or uncontrolled hypertension)
- Patient with family history of long QT syndrome, of unexplained syncope or of unexplained sudden death
- 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, history of pancreatitis
- History of non-compliance to medical regimens
- 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, voriconazole, erythromycin, clarithromycin, telithromycin)
- Concomitant treatment with warfarin
- Concomitant treatment with anti-arrhythmic drug (e. g. amiodarone, sotalol, disopyramide, quinidine, procainamide) or medication that prolongs the QT interval (e.g. chloroquine, chlorpromazine, domperidone, droperidol, halofantrine, haloperidol, methadone, pentamidine, pimozide, thioridazine)
- Prior treatment with imatinib except if no progression was demonstrated
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01261429
Start Date
December 1 2010
End Date
April 1 2013
Last Update
April 16 2013
Active Locations (15)
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1
Institut Bergonié
Bordeaux, France
2
Centre Oscar Lambret
Lille, France
3
Centre Léon Bérard
Lyon, France
4
Hôpital La Timone
Marseille, France