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    Summary
    EudraCT Number:2015-002308-10
    Sponsor's Protocol Code Number:TOPIC-2
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-07-09
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-002308-10
    A.3Full title of the trial
    A randomized, single blinded trial to evaluate the efficacy of Imiquimod in women with residual/recurrent Cervical Intraepithelial Neoplasia (CIN) after previous treatment
    Een gerandomiseerde, enkel geblindeerde trial om het effect te evalueren in vrouwen met een recidief/residue CIN (cervicale intraeptheliale neoplasie) na eerdere chirurgische behandeling
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with immunemodulating creme of patients with recurrent/residualprecancerous lesions of cervix after previous treatment
    Behandeling met immuunmodulerende creme van patientenmet een terugkerend of blijvend voorstadium van baarmoederhalskanker na eerdere behandeling
    A.3.2Name or abbreviated title of the trial where available
    TOPIC-2
    A.4.1Sponsor's protocol code numberTOPIC-2
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Imiquimod (aldara) creme 5%
    D.2.1.1.2Name of the Marketing Authorisation holderMeda AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameImiquimod 5% creme
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    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 Yes
    D.3.11.13.1Other medicinal product typeNSAID during treatment in case of side effects
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Residual or recurrent Cervical Intraepithelial Neoplasia (CIN)
    Recidief of residue CIN (cervicale intraepitheliale neoplasie)
    E.1.1.1Medical condition in easily understood language
    Precancerous lesions of the cervix despite previous operative treatment
    Voorstadium van baarmoederhalskanker ondanks eerdere behandeling
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the efficacy of imiquimod 5% cream compared to treatment with Large Loop excision of the transformation zone (LLETZ) for recurrent/residual CIN.
    Evaluatie van de effectiviteit van Imiquimod 5% creme vergeleken met de LLETZ (Large Loop Excision of transformation zone) voor recidief of residue CIN afwijkingen
    E.2.2Secondary objectives of the trial
    Evaluation of the effect of treatments on HPV DNA presence in CIN lesions
    Evaluations of tolerability of imiquimod in CIN lesions
    Evaluation of quality of life
    Establishment of long term recurrence rate of CIN lesions
    Effect van behandeling op HPV DNA aanwezigheid in CIN leasies
    Verdraagbaarheid van Imiquimod bij CIN laesies
    Quality of life
    Lange termijn behandelingsresultaten
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically proven CIN2 or CIN 3, without invasion after previous surgical treatment at least 6 months before diagnosis
    - Histologically proven persistent CIN 1 after previous surigcal treament at least 6 months before diagnosis. Persistent CIN 1 is defined as CIN 1 at least persistent for 6 months and proven with histology
    - The patient is willing to use a medically acceptable method of contraception throughout the study
    - Women older than 18 years of age
    - Histologisch bewezen CIN 2 of CIN 3 zonder invasie na eerdere chirurgische behandeling minstens 6 maanden voor de diagnose
    - Histologisch bewezen persisterende CIN1 na eerdere chirurgische behandeling ten minste 6 maanden voor de diagnose. Persisterende CIN 1 is gedefineerd als CIN voor ten minste 6 maanden persisterend en bewezen met histologie.
    - De patiente gebruikt een acceptabele methode van anticonceptie gedurende de studie
    - vrouwen ouder dan 18 jaar
    E.4Principal exclusion criteria
    - Pregnancy or lactation
    - (Micro-)invasive carcinoma
    - Past history of cervical cancer
    - Hypersensitivity of any components of the formulation
    - History of psoriasis or other inflammatory dermatosis of the vulva
    - Immunodeficiency or treatment with immunosuppressive medication
    - Insufficient understanding of the Dutch or English language
    - zwangerschap of lactatie
    - (micro) invasief carcinoom
    - voorgeschiedenis van cervixcarcinoom
    - Overgevoeligheid voor de bestandsdelen van de medicatie
    - voorgeschiedenis van psoriasis of andere inflammatoire dermatosen van de vulva
    - Immuuncompressie of behandeling met immunocompressiva
    - onvoldoende begrip van nederlandse of engelse taal
    E.5 End points
    E.5.1Primary end point(s)
    - Reduction from CIN 2-3 or persistent CIN 1 to normal cytology 6 months after start treatment.
    - afname van CIN2-3 of persisterende CIN 1 tot normale cytologie 6 maanden na de behandeling
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after start treatment
    6 maanden na start behandeling
    E.5.2Secondary end point(s)
    o Presence or absence of HPV DNA in CIN lesions at 0 and 26 weeks.
    o Reduction from CIN to no dysplasia 10 weeks after the treatment with imiquimod.
    o Improvement in quality of life
    o Side effects of imiquimod
    o Durability of the clinical response at 12 and 24 months
    o Long term recurrence defined by follow up in the screening program for cervical cancer in The Netherlands
    - aanwezigheid of afwezigheid van HPV DNA in CIN laesies op week 0 en week 26
    - reductie van CIN naar geen dysplasie 10 weken na de behandeling met imiquimod
    - verbeterig in kwaliteit van leven
    - bijwerkingen van imiquimod
    - duur van de klinische respons bij maand 12 en 24
    - lange termijn uitkomsten gedefineerd als eerste uitstrijkje bij follow up in het Nederlandse screening programma ter preventie van cervicarcinoom
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 10 weeks after treatment with imiquimod
    - at inclusion, 6 and 12 months after treatment
    - during the treatment with imiquimod
    - 12 and 24 months after start treatment
    - first cervical smear according to dutch screening program
    - 10 weken na de behandeling met imiquimod
    - bij inclusie, 6 en 12 maanden na behandeling
    - gedurende de behandeling met Imiquimod
    - 12 en 24 maanden na start behandeling
    - eerste uitstrijkje volgens het Nederlandse screening programma
    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 No
    E.6.10Pharmacogenetic No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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 Yes
    E.8.2.3.1Comparator description
    Large Loop Excision of the transformation Zone (LLETZ)
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    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 Yes
    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
    Trial will end when 276 patients are included
    If any unexpected severe side effects occur, the study will be prematurely terminated after advise of the DMSB.
    A Serious Adverse Event is any untoward medical occurrence or effect that at any dose
    - results in death
    - is life threatening
    - requires hospitalisation or prolongation of existing hospitalisation
    - results in persistent or significant disability or incapacity
    - is a new event of the trial likely to affect the safety of the subjects
    Trial zal eindigen na inclusie van 276 patienten.
    Bij optreden onverwachte ernstige bijwerkingen, zal de studie beeindigd worden na advies van de DMSB.
    Een ernstige bijwerking is een ongunstige medische gebeurtenis dat in elke dosering:
    leidt tot overlijden
    -levensbedreigend is
    - ziekenhuis opname vereist of verlenging van bestaande opname
    - resulteert in peristerende of significante handicap
    - een nieuw evenement van de trial die waarschijnlijk de veiligeid van de deelnemers beinvloedt
    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 months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 410
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state276
    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 be following follow up for 2 years according to the current guidelines for patients with CIN treated with LLETZ
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-20
    P. End of Trial
    P.End of Trial StatusOngoing
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