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    Summary
    EudraCT Number:2013-003336-72
    Sponsor's Protocol Code Number:81413F
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-09-11
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-003336-72
    A.3Full title of the trial
    A Phase IIb study of topic DAC-0060, a synthetic histone deacetylase inhibitor, plus Tazarotene in patients with cutaneous basal cell carcinoma (BCC)
    Studio di Fase IIb con DAC-0060 topico, un inibitore sintetico dell’ enzima deacetilasi in associazione a Tazarotene in pazienti con carcinoma basocellulare cutaneo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study for patients with cutaneous basal cell tumor evaluating the role of topical DAC-0600 plus Tazarotene
    Studio clinico per pazienti con tumore basocellulare della pelle per valutare il ruolo del trattamento locale con DAC-0060 in associazione a Tazarotene
    A.4.1Sponsor's protocol code number81413F
    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 SponsorISTITUTO EUROPEO DI ONCOLGIA
    B.1.3.4CountryItaly
    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 supportDAC srl
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTO EUROPEO DI ONCOLGIA
    B.5.2Functional name of contact pointTRIALS & REGULATORY ACTIVITIES OFFI
    B.5.3 Address:
    B.5.3.1Street AddressVIA RAMUSIO 1
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20141
    B.5.3.4CountryItaly
    B.5.6E-mailuffico.studiclinici@ieo.it
    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 No
    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.3.2Product code DAC-0060
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Epilesional 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 No
    D.IMP: 2
    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 ZORAC
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre Italia S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameZORAC
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Epilesional 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 No
    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
    BASAL CELL CARCINOMA
    carcinoma basocellulare cutaneo
    E.1.1.1Medical condition in easily understood language
    SKIN CANCER
    TUMORE CUTANEO
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10004146
    E.1.2Term Basal cell carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess anti-tumor activity of DAC-0060 + Tazarotene 0.1% gel topic combination in the treatment of superficial and nodular basal cell skin cancer
    Valutare l’attività antitumorale della combinazione DAC-0060 + Tazarotene 0.1% gel topico nel trattamento del carcinoma basocellulare cutaneo superficiale e nodulare
    E.2.2Secondary objectives of the trial
    To evaluate the safety profile after repeated administrations of DAC-0060 + Tazarotene 0.1% gel topic combination in patients treated at the recommended doses
    Valutare il profilo di sicurezza di somministrazioni ripetute della combinazione DAC-0060 + Tazarotene 0.1% gel topico in pazienti trattati alla dose raccomandata
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • A primary histologically confirmed BCC.
    • Relapsing and/or not respondent BCC.
    • Patients aged >18 years.
    • Patients must have at least one unidimensionally measurable lesion between 1 and 3 cm.
    • Negative serum pregnancy test for females of childbearing potential within 14 days of starting treatment.
    • If of childbearing potential, agreement to use adequate contraceptive methods (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) beginning at the screening visit and continuing until 3 months following last treatment with study drug.
    • Willing to abstain from application of non-study topical medications to the skin, during the study, including prescription and over the counter preparations.
    • Evidence of a personally signed and dated Ethics Committee-approved Informed Consent indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the study.
    • Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
    • Patients already planned to undergo excision of the area treated during the trial period.
    • Agreement from the patient to allow photographs of the selected lesion to be taken and used as part of the study data package.
    • Un carcinoma basocellulare cutaneo confermato istologicamente
    • Pazienti con carcinoma basocellulare naive
    • Carcinoma basocellulare cutaneo recidivante e/o non rispondente
    • Pazienti di età > ai 18 anni
    • I pazienti devono avere almeno una lesione misurabile unidimensionalmente tra 1 e 3 cm
    • Test di gravidanza negativo in donne in età fertile entro 14 giorni dall’ inizio del trattamento
    • Se donne potenzialmente fertile, accordo all’utilizzo di adeguati metodi contraccettivi (contraccettivi orali, condoms, o altri adeguati controlli di barriera, strumenti contraccettivi intrauterine, o sterilizzazione) a partire dalla visita di screening e continuando fino ai 3 mesi successive l’ultimo trattamento in studio
    • Volontà ad astenersi dalla applicazione di medicamenti topici per la pelle non previsti dallo studio, durante lo studio, inclusi preparati prescrivibili e non.
    • Evidenza di un Consenso Informato approvato dal Comitato Etico firmato e datato che indichi che il paziente (o il suo rappresentante legale) sia stato informato di tutti gli aspetti pertinenti dello studio
    • Volontà di aderire al programma di visite previste, al trattamento programmato, ai tests di laboratorio e alle alter procedure di studio
    • Pazienti già programmati a subire una escissione dell’area trattata durante il periodo di studio
    • Accordo del paziente a permettere che le fotografie della lesione selezionata siano effettuate e usate come facente parte dei dati dello studio
    E.4Principal exclusion criteria
    • Non melanoma skin cancer other than BCC.
    • Presence of active infections (e.g. requiring antibiotic therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
    • Presence of known metastases.
    • Known to have a second uncontrolled cancer of other primary origin within the last 5 years.
    • Known history of hypersensitivity to any of the ingredients of the study medication formulation.
    • Pregnancy or breast feeding. Female patient must agree to use effective contraception, or be surgically sterile or postmenopausal. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
    • Participation to other studies or treatment with an investigational study drug in the last six months.
    • Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.
    • Transplanted patients
    Tumore della pelle di tipo non melanoma diverso dal carcinoma basocellulare cutaneo
    • Presenza di infezioni attive (ex. richiedenti terapia antibiotica) o altra patologia concomitante che, secondo l’opinione dell’investigatore, potrebbe sottoporre il paziente ad un rischio ingiustificato o interferire con lo studio.
    • Presenza di metastasi note
    • Storia nota di un secondo tumore incontrollato di altra origine primaria negli ultimo 5 anni
    • Storia nota di ipersensibilità ad un qualunque componente del trattamento di studio
    • Gravidanza o allattamento. Pazienti di sesso femminile devono essere d’accordo ad utilizzare un contraccettivo efficace, o essere chirurgicamente sterile o in postmenopausa. La definizione di contraccettivo efficace si baserà sul giudizio del principal investigator o di un associate designato.
    • Partecipazione ad altri studi o trattamento con farmaco sperimentale negli ultimo sei mesi.
    • Qualunque condizione che a giudizio dello sperimentatore potrebbe ostacolare la compliance con il protocollo in studio
    • Pazienti trapiantati
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of the composite response
    Valutazione della risposta composita
    E.5.1.1Timepoint(s) of evaluation of this end point
    9 weeks after the beginning of treatment
    9 settimane dall’ inizio del trattamento
    E.5.2Secondary end point(s)
    Evaluation of the objective response
    Evaluation of the overall response
    Toxicity
    Valutazione della risposta obiettiva
    Valutazione della risposta complessiva
    Tossicità
    E.5.2.1Timepoint(s) of evaluation of this end point
    9 weeks after the beginning of treatment
    9 settimane dall’ inizio del trattamento
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 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 state80
    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 followed up after the end of the adjuvant treatment. In case of relapse they will undergo the standard programs for diagnosis and treatment.
    I pazienti verranno avviati al follow up al termine del trattamento adiuvante. In caso di progressione di malattia verranno avviati ai programmi di stadiazione e trattamento standard.
    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 Decision2013-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-30
    P. End of Trial
    P.End of Trial StatusOngoing
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