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

CENTRE LEON BERARD0 sites56 target enrollmentMarch 28, 2011

Overview

No summary available.

Registry

who.int

Start Date

March 28, 2011

End Date

October 4, 2013

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- 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 (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 \=1\.5 x ULN, ALT and AST \=2\.5 x ULN, serum creatinine \=1\.5 x ULN or creatinine clearance \=50 mL/min, absolute neutrophil count (ANC) \=1\.5x10\.9/L, platelets \=100x10\.9/L, serum lipase \=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)
•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 or glucose\-galactose malabsorbtion prior to enrolment
•\- 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