Phase II study of nilotinib efficacy in Pigmented Villo-Nodular Synovitis/Tenosynovial Giant Cell Tumour (PVNS/TGCT) - PVNS

Centre Leon-Berard0 sites56 target enrollmentOctober 24, 2011

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with inoperable Pigmented Villonodular Synovitis / Tenosynovial Giant Cell Tumour (PVNS/TGCT)
Sponsor: Centre Leon-Berard
Enrollment: 56
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

October 24, 2011

End Date

October 4, 2013

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•Age \=18 years
•Histologically confirmed diagnosis of inoperable progressive or relapsing PVNS or resectable tumour requiring 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 based on investigators assessment
•WHO Performance status of 0,1,or 2
•Adequate organ, electrolyte and marrow function as defined in protocol.
•Prior adequate physical examination including weight, height, ECOG Performance Status 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 applicable countries \- not applicable to UK)
•Are the trial subjects under 18? no

•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 of or glucose\-galactose malabsorption prior to enrolment.
•Acute or chronic uncontrolled liver disease, or severe renal disease
•Impaired cardiac function as defined by protocol
•Patient with family history of long QT syndrome, or unexplained syncope or 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 medical products that induce CYP3A4(e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or St.Johns 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 or medication that prolongs the QT interval