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    Summary
    EudraCT Number:2011-001739-21
    Sponsor's Protocol Code Number:FiDoAp
    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:2012-03-13
    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 number2011-001739-21
    A.3Full title of the trial
    A study of Sativex for pain Relief and appetite stimulation in Patients with advanced malignancy. Phase II
    Studio monocentrico di fase II per la valutazione degli effetti clinici ed immunologici dei Fitocannabinoidi sul dolore e sull'appettito nei pazienti oncologici in fase avanzata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Sativex for pain Relief and appetite stimulation in Patients with advanced malignancy. Phase II
    Studio monocentrico di fase II per la valutazione degli effetti clinici ed immunologici dei Fitocannabinoidi sul dolore e sull’appettito nei pazienti oncologici in fase avanzata”
    A.4.1Sponsor's protocol code numberFiDoAp
    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 NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE "G. PASCALE"
    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 supportRicerca Corrente
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Tumori di Napoli
    B.5.2Functional name of contact pointDirezione Scientifica
    B.5.3 Address:
    B.5.3.1Street AddressVia Mariano Semmola
    B.5.3.2Town/ cityNapoli
    B.5.3.3Post code80131
    B.5.3.4CountryItaly
    B.5.4Telephone number081 5903 531
    B.5.6E-mailmario.tamburini.1@alice.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 sativex
    D.2.1.1.2Name of the Marketing Authorisation holderBayer healt care
    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.3.4Pharmaceutical form Pressurised inhalation
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1972-08-3
    D.3.9.2Current sponsor codeMarinol®; Elevat®
    D.3.9.3Other descriptive nameΔ9-tetrahydrocannabinol; Δ9-THC; delta-9-THC4; THC5
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    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
    advanced malignant cancer
    stato avanzato di cancro
    E.1.1.1Medical condition in easily understood language
    advanced malignant cancer
    stato avanzato di cancro
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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
    The purpose of this study is to determine the effective dose range in patients with advanced cancer, who experience inadequate pain relief even though they are on optimized chronic opioid therapy and on lacking of appetite and malnutrition
    valutare come gli agonisti dei recettori del sistema degli endocannabinoidi ed in particolare i fitocannabinoidi, possano migliorare il quadro clinico della malnutrizione e della cinestesi, principale causa di morte nei pazienti tumorali,frequentemente associata ai tumori in fase avanzata attraverso l’effetto che questi composti possano esercitare sulle citochine pro infiammatorie associate alla malnutrizione per la modulazione che essi hanno sui recettori CB2 presenti sulle cellule del sistema immunitario.
    E.2.2Secondary objectives of the trial
    na
    na
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • The patient has advanced active cancer for which there is no known curative therapy. • The patient is able (in the investigators opinion) and willing to comply with all study requirements. • The patient has a clinical diagnosis of cancer related pain, which is not wholly alleviated with their current opioid treatment. • The patient is receiving a sustained release (SR) fixed dose of opioid therapy (excluding Methadone). N.B. The opiate therapy must be Step III according to the WHO analgesic ladder. • The patient is willing to continue to take their regular daily baseline opioid regimen (SR) at the same dose, throughout the duration of study.
    Il paziente è in uno stato avanzato di cancro per il quale non ci sono terapie curative. Il paziente è capace e di seguire le regole dello studio Il paziente ha una diagnosi di dolore associato al cancro, che non è completamente coperto dalla terapia con oppioidi valutati con scala VAS Il paziente è malnutrito: BMI &lt;20 kg/m con calo ponderale del 10% nei sei mesi precedenti, La terapia oppiacea deve essere StepIII secondo la scala WHO analgesic ladder nei tre mesi precedenti o 5% nel mese precedente Il paziente continuerà a prendere la dose giornaliera di oppioidi per tutta la durata dello studio Ipofagia Assunzione di cibo rispetto all’abituale valutato con diario nutrizionale e scala VAS
    E.4Principal exclusion criteria
    • The patient should be excluded from entering study if they have received or are due to receive during the study period; chemotherapy, hormone therapy or radiotherapy, which, in the opinion of the investigator will affect their pain. • Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition. • Any known or suspected history of a diagnosed dependence disorder, current heavy alcohol consumption, current use of an illicit drug or current non prescribed use of any prescription drug. • The patient has poorly controlled epilepsy or recurrent seizures (i.e. at least one year since last seizure). • The patient has experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the patient at risk of a clinically relevant arrhythmia or myocardial infarction.
    Il paziente deve essere escluso dallo studio se sono programmati cicli di chemioterapia, ormonoterapia o radioterapia, che nell’opinione degli investigatori potrebbero influire sull’esito dello studio. Qualsiasi episodio familiare di schizofrenia, malattia psicotiche, disturbi della personalità o stati depressivi. Qualsiasi storia sospetta disordini da dipendenza da droghe, consumi alcolici elevati,. Il paziente ha avuto nell’anno episodi di epilessia. Il paziente ha avuto negli ultimi 12 mesi episodi di infarto del miocardio che potrebbero secondo gli investigatori mettere a rischio il paziente di episodi di aritmia o infarto del miocardio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the IVRS 11-point Numeric Rating Scale pain score (average pain). The primary outcome measure is the IVRS 11-point Numeric Rating Scale pain score (average pain) at time 0,1,2.
    A) IVRS 11- point numeric rating scale pain score B) Scored Patients Generated Global Assessment (PG-SGA) C) Prelievi di sangue all’entrata nello studio al tempo T0, a 30 giorni T1 e a 60 giorni T2 per l’analisi qualitativa e quantitativa delle citochine: IL-1,IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, IFN , TNF
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary outcome measure is the IVRS 11-point Numeric Rating Scale pain score (average pain). The primary outcome measure is the IVRS 11-point Numeric Rating Scale pain score (average pain) at time 0,1,2.
    1. Somministrazione di questionari per la valutazione del dolore e della malnutrizione; 2. Prelievi di sangue all’entrata nello studio al tempo T0, a 30 giorni T1 e a 60 giorni T2 per l’analisi qualitativa e quantitativa delle citochine: IL-1,IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, IFN , TNF
    E.5.2Secondary end point(s)
    non applicabile
    non è previsto nessun end-point secondario
    E.5.2.1Timepoint(s) of evaluation of this end point
    na
    not applicable
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial2
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned 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.1.1.2Preterm 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: 98
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 98
    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 state188
    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)
    na
    na
    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 Decision2012-03-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-18
    P. End of Trial
    P.End of Trial StatusOngoing
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