Study of nilotinib efficacy in Pigmented Villo-Nodular Synovitis / Tenosynovial Giant Cell Tumor

Phase 1

• Conditions: MedDRA version: 14.0 Level: LLT Classification code 10042875 Term: Synovitis villonodular System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Cancer [C04]; Patients with inoperable Pigmented Villonodular Synovitis / Tenosynovial Giant Cell Tumour (PVNS/TGCT)

• Registration Number: EUCTR2010-018869-29-GB
• Lead Sponsor: Centre Leon-Berard

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-24
• Study Completion: 2013-10-04
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 56

Inclusion Criteria

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
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

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
Prior treatment with imatinib except if no progression was demonstrated

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified