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    Summary
    EudraCT Number:2010-018869-29
    Sponsor's Protocol Code Number:ET2009-095
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-24
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2010-018869-29
    A.3Full title of the trial
    Phase II study of nilotinib efficacy in Pigmented Villo-Nodular Synovitis/Tenosynovial Giant Cell Tumour (PVNS/TGCT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of nilotinib efficacy in Pigmented Villo-Nodular Synovitis /
    Tenosynovial Giant Cell Tumor
    A.3.2Name or abbreviated title of the trial where available
    PVNS
    A.4.1Sponsor's protocol code numberET2009-095
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01261429
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCentre Leon-Berard
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Laboratory
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Tasigna
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTasigna
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNilotinib
    D.3.9.1CAS number 641571-10-0
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration numberN/A
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with inoperable Pigmented Villonodular Synovitis /
    Tenosynovial Giant Cell Tumour (PVNS/TGCT)
    E.1.1.1Medical condition in easily understood language
    Patients with inoperable Pigmented Villonodular Synovitis /
    Tenosynovial Giant Cell Tumour (PVNS/TGCT)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10042875
    E.1.2Term Synovitis villonodular
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To measure the effectiveness of 12 weeks (3 months) of nilotinib treatment in preventing disease progression by measuring overall response (Complete response + Partial Response + Stable disease) according to Response Evaluation Criteria In Solid Tumours – RECIST version 1.1) in patients with progressive or relapsing PVNS/TGCT who cannot be treated by surgery.
    E.2.2Secondary objectives of the trial
    Second, the study will measure the effectiveness of 24 weeks (6 months) of nilotinib treatment in preventing disease progression by measuring overall response (Complete response + Partial Response + Stable disease) according to Response Evaluation Criteria In Solid Tumours – RECIST version 1.1)in the same group of patients

    The study will also assess the efficacy of nilotinib according to:
    - The objective tumour response rate (Complete response + Partial Response according to RECIST version 1.1) after 12 weeks of treatment
    - The duration of treatment response
    - The best overall response obtained during the study
    - The progression-free survival (PFS)
    - The time to progression (TTP)
    - The time to treatment failure (TTF)
    - The proportion of patients with an operable tumour after nilotinib treatment according to investigator evaluation
    - The description of concomitant treatments use
    - The correlation between trough levels of nilotinib and objective tumour response
    - To assess
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Complementary biologic study
    An exploratory objective of the study will be to study the relationship
    between the objective tumour response and the following tumour
    characteristics (tissues collected in a prior surgery, or by biopsy, upon
    specific acceptance by the patient):
    - Presence of COL6A3/CSF1 fusion gene
    - Presence of M-CSF, CSF1R, KIT, PDGFRA and B on
    immunohistochemistry
    - Presence of phosphorylated c-fms on tumour samples
    - Activation of the PI3K/Akt/mTor pathway, presence of activating
    mutations of ras, and other potential molecular alterations
    E.3Principal 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)
    E.4Principal 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
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure will be the non progression rate after 12 weeks of treatment, based on the response evaluated by CT/MRI according to RECIST criteria and validated by central review committee.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    Key secondary efficacy endpoint: Non progression rate after 24 weeks (6
    months) of treatment, based on the response evaluated by CT scan or
    MRI according to RECIST criteria (RECIST version 1.1).
    Other secondary efficacy endpoints:
    - Objective tumour response according to RECIST version 1.1 (CR and
    PR) after 12 weeks of treatment
    - Duration of response
    - Best overall response
    - Progression-free survival
    - Time to progression
    - Time to treatment failure
    - Non progression rate after 12 weeks of treatment, based on the
    response evaluated locally by the investigator in charge using CT scan or
    MRI and according to RECIST criteria (RECIST version 1.1)
    - Proportion of patients with an operable tumour after nilotinib exposure
    according to investigator evaluation
    - Concomitant treatment use during the study
    - Correlation between trough level of nilotinib at 6 weeks and 12 weeks
    and objective tumour response
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 weeks
    12 weeks
    24 weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of study is defined as the end of the clinical study of the last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will continue routine care as clinically indicated on completion of the study. Patients will not receive nilotinib after the completion of the study.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-04-17
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