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    Summary
    EudraCT Number:2009-012049-46
    Sponsor's Protocol Code Number:IEO S480/209
    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:2009-07-20
    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 number2009-012049-46
    A.3Full title of the trial
    Phase III, randomized, double blind trial on Vitamin D supplementation for resected stage II melanoma patients.
    A.3.2Name or abbreviated title of the trial where available
    MelaVid
    A.4.1Sponsor's protocol code numberIEO S480/209
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorISTITUTO EUROPEO DI ONCOLOGIA
    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 support
    B.4.2Country
    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 DIBASE*IM OS 6F 1ML 100000UI/M
    D.2.1.1.2Name of the Marketing Authorisation holderABIOGEN PHARMA SpA
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNColecalciferol
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100000
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    melanoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level HLT
    E.1.2Classification code 10027156
    E.1.2Term Skin melanomas (excl ocular)
    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 effect of Vitamin D supplementation (100.000 IU/ml every 50 days vs placebo) on Disease Free Survival (DFS) for resected stage II melanoma patients.
    E.2.2Secondary objectives of the trial
    to verify whether Vitamin D3 receptors polymorphisms and serum level of 25(OH)D are associated to melanoma prognostic factors;
    to evaluate vitamin D biology and metabolisms, investigating changes in 25(OH)D by genetic variants and PTH;
    to evaluate the association between 25(OH)D serum levels and anthropometric measures (such as BMI, waist-to-hip ratio, waist-to-stature ratio), dietary intakes (vitamin D, calcium and fat intake), occupation and different patterns of sun exposures;
    to determine the percentages of patients who will reach, during the first year of treatment, the desired serum level of 25(OH)D and mean time to reach that level (30 ng/ml);
    to evaluate safety and toxicity in this cohort of patients;
    to evaluate compliance with a dose given every 50 days po;
    to develop a biorepository of blood samples, collected at several time points. This will create a large biological database for future research (e.g., molecular characteristics of intervention effica
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    QUALITA DELLA VITA: Versione:1 Data:2009/06/03 Titolo:Biomarker studies on vitamin D and melanoma: Vitamin D receptors, serum levels of 25(OH)D, sun exposure and dietary intake with melanoma prognostic factors. Obiettivi:L�endpoint principale riguarda l�associazione tra i polimorfismi della VDR (i recettori della vitamina D) e lo spessore di Breslow,

    ALTRI SOTTOSTUDI: Gene-gene and gene-environment interactions on vitamin D and melanoma prognosis Versione n.1 del 03/06/2009

    L�endpoint principale riguarda l�interazione tra i polimorfismi della VDR (i recettori della vitamina D) e lo spessore di Breslow, il principale fattore prognostico.
    Lo studio valutera` anche l�associazione con gli altri fattori prognostici (numero di mitosi, sesso, eta`, ulcerazione e posizione del tumore), l�esposizione solare, i livelli di 25(OH)D, e i geni che codificano per gli enzimi che sintetizzano, trasportano e degradano la vitamina D.
    E.3Principal inclusion criteria
    18-75 years of age with newly diagnosed histologically proven resected melanoma;
    stage: IIa (T2b, T3a), IIb (T3b T4a) and IIc (T4b), N0, M0;
    signed informed consent;
    willingness to provide blood samples;
    performance Status of 0-1 (ECOG);
    hematopoietic functionality at the entry of the study: leukocytes, platelets, haemoglobin and neutrophiles within the normal limits of laboratory references;
    hepatic and renal functionality at the entry of the study: LDH, bilirubin, AST, ALT, alkaline phosphatase, BUN and serum creatinine in the normal range of each laboratory;
    serum and urinary calcium within the upper limit of laboratory references.
    E.4Principal exclusion criteria
    primary not cutaneous melanoma;
    clinical/radiological evidence or laboratory/pathology report of not completely resected melanoma;
    history of cancer (other than CIN and NMSC);
    current daily use of at least 600 IU/day of supplemental vitamin D or calcitriol or high dose of calcium therapy (e.g. calcium citrate with vitamin D) within the prior 6 months and supplemental calcium greater than 600 mg calcium per day during study;
    history of recurrent renal calculi or hypercalcemia (>10mg/dl), current and chronic use of oral corticosteroids;
    history of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, Crohn disease, or tropical sprue)
    history of small intestinal resection > 50% (e.g., ileal bypass surgery for treatment of morbid obesity)
    hypersensitivity to cholecalciferol or one of its components
    pre-existing parathyroid conditions (including hyperparathyroidism), sarcoidosis
    chronic liver disease, chronic renal disease, or renal dialysis
    history of parathyroid disease
    pregnancy or breast feeding or planning on becoming pregnant
    chronic alcoholism
    any medical condition that in the physician�s opinion would potentially interfere with vitamin D absorption, such as celiac sprue, ulcerative colitis, Crohn disease, patients treated pharmacologically for obesity;
    logistic problems that do not allow follow-up of the patient.
    E.5 End points
    E.5.1Primary end point(s)
    Disease free survival
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned17
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=65 years) Yes
    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 state878
    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 Decision2010-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-15
    P. End of Trial
    P.End of Trial StatusOngoing
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