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    Summary
    EudraCT Number:2015-002748-16
    Sponsor's Protocol Code Number:CRO-2015-38
    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:2021-01-25
    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 number2015-002748-16
    A.3Full title of the trial
    Cryotherapy for onicopatie induced by paclitaxel. CRIOP
    La crioterapia per le onicopatie indotte da paclitaxel. CRIOP
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    La crioterapia per le onicopatie indotte da paclitaxel. CRIOP
    La crioterapia per le onicopatie indotte da paclitaxel. CRIOP
    A.3.2Name or abbreviated title of the trial where available
    CRIOP
    CRIOP
    A.4.1Sponsor's protocol code numberCRO-2015-38
    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 SponsorCENTRO DI RIFERIMENTO ONCOLOGICO
    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 supportCentro di Riferimento Oncologico di Aviano
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentro Riferimento Oncologico
    B.5.2Functional name of contact pointUfficio Studi Clinici
    B.5.3 Address:
    B.5.3.1Street AddressVia F. Gallini 2
    B.5.3.2Town/ cityAviano (PN)
    B.5.3.3Post code33081
    B.5.3.4CountryItaly
    B.5.4Telephone number0434659066
    B.5.5Fax number0434659453
    B.5.6E-mailgtabaro@cro.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 Yes
    D.2.1.1.1Trade name PACLITAXEL ACTAVIS - 6 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 50 ML
    D.2.1.1.2Name of the Marketing Authorisation holderACTAVIS ITALY 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 namePACLITAXEL
    D.3.2Product code L01CD01
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    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
    breast cancer
    CARCINOMA MAMMARIO
    E.1.1.1Medical condition in easily understood language
    breast cancer
    CANCRO AL SENO
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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
    Assess the impact of cryotherapy in reducing the incidence of onicopatie of moderate / severe intensity in addition to the 12
    Valutare l¿impatto della crioterapia nella riduzione dell¿incidenza delle onicopatie di moderata/grave intensit¿ a completamento delle 12 somministrazioni settimanali di paclitaxel.
    E.2.2Secondary objectives of the trial
    1) evaluate the "time to the appearance" of each of onicopatie degree calculated in number of days from the start of therapy;
    2) assess the tolerance and patient compliance through the intervention of cryotherapy satisfaction scale to 2 items (satisfied, not satisfied).
    1) valutare il ¿tempo alla comparsa¿ delle onicopatie di ogni grado calcolato in numero di giorni dall¿inizio della terapia;
    2) valutare la tolleranza e la compliance delle pazienti all¿intervento di crioterapia attraverso scala di soddisfazione a 2 items (soddisfatto, non soddisfatto).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Patients with breast cancer and undergoing adjuvant therapy with weekly paclitaxel (80 to 100 mg / m) for at least 12 weeks;
    2) Collaboration and written informed consent to treatment
    1)Pazienti affette da carcinoma mammario e sottoposte a terapia adiuvante con paclitaxel settimanale (da 80 a 100 mg/mq) per almeno 12 settimane;
    2)Collaborazione al trattamento e consenso informato scritto
    E.4Principal exclusion criteria
    1) Previous nail diseases;
    2) Syndrome Raynoud;
    3) Prior treatment with taxanes;
    4) no treatment compliance or lack of cooperation
    1) Precedenti patologie ungueali;
    2) Sindrome di Raynoud;
    3) Precedenti trattamenti con taxani;
    4) Non compliance al trattamento o scarsa collaborazione.
    E.5 End points
    E.5.1Primary end point(s)
    Percentuale di pazienti con onicopatie G2-G3 (sec CTCAE v 4.03) valutate a completamento delle 12 somministrazioni settimanali di paclitaxel
    E.5.1.1Timepoint(s) of evaluation of this end point
    SETTIMANALE
    E.5.2Secondary end point(s)
    Tempo alla comparsa di onicopatia (calcolato dalla prima somministrazione del paclitaxel, in giorni).
    E.5.2.1Timepoint(s) of evaluation of this end point
    giorni
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    1 year
    1 anno
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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: 31
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 31
    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 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 state62
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 62
    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)
    as per normal clinical practice
    come da normale pratica clinica
    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 Decision2015-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-19
    P. End of Trial
    P.End of Trial StatusOngoing
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