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    Summary
    EudraCT Number:2009-014652-30
    Sponsor's Protocol Code Number:SPK-843-03/01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-01-15
    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 number2009-014652-30
    A.3Full title of the trial
    Efficacy, safety and pharmacokinetics of SPK-843 in the treatment of pulmonary mycosis.Phase III Open clinical study
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberSPK-843-03/01
    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 SponsorPRO APARTS SRL
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 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 SPK-843
    D.3.4Pharmaceutical form Powder for infusion*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeSPK-843
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Yes
    D.3.11.13.1Other medicinal product typesintesi chimica semisintetica derivato d a Partricina A(daStreptomyces aureofaciens NRRL 3878 )
    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
    pulmonary mycosis(cryptococcosis o aspergillosis)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10037371
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10059259
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10027833
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of clinical response based on the total global secondary end points 1 to 6 at the end of treatment (Study Day 14) and the final study visit - follow up - (Study Day 28), compared to the initial clinical status. The assessment will be based on improvement / normalization on a semi-quantitative scale to 3.4 and 5 items or assessed as positive for at least 3 of the first 6 secondary end points
    E.2.2Secondary objectives of the trial
    Improvement on the basis of clinical symptoms. Effectiveness antifungal crop. Improvement on the basis of serology mycology. Improvement on the basis of the diagnostic laboratory (emogasanalisi, VES, CPR) Improvement on radiological imaging (X-ray, CT HR). Improvement on the basis of endoscopic. To assess the plasma levels of SPK-843 after a single dose and after multiple doses. Assessing security in the administration of SPK-843.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    FARMACOCINETICA/FARMACODINAMICA: Versione:Finale/01 Data:2009/07/18 Titolo:Efficacia, sicurezza e farmacocinetica di SPK-843 nel trattamento delle micosi polmonari. Studio clinico in aperto di fase III. Obiettivi: Valutazione Farmacocinetica: valutazione per singola dose e per dose ripetuta del profilo farmacocinetico di SPK-843. I valori dei livelli ematici del farmaco verranno visualizzati in formato tabellare. Per ogni paziente, la curva concentrazione/tempo sara` tracciata secondo una scala in maniera lineare e logaritmica. Effettuata ai tempi T0, T3, T7, T10, T14, T21 e T28.
    E.3Principal inclusion criteria
    Patients with fungal etiology demonstrated by an examination of micologic culture (crop) and histopathological examination (patients with definite diagnosis), or patients with fungal infection which is difficult to determine the causative agent but with a diagnosis of deep mycosis based on serological test for fungal infection and / or clinical radiological investigation, and / or clinical endoscopic investigation, clinical symptoms (patients with clinical diagnosis). Patients treated with other antifungal drugs with a poor response to treatment after at least 5 days of administration of the antifungal drug, which had an adverse drug reaction that affects the use, considering the risk / benefit profile for the patient. Age between 18 and 75 years. Subjects are able to understand what is written in the form of informed consent and eager to participate in the trial. Male and female. Patients admitted to the hospital identified for the trial in question. Informed consent
    E.4Principal exclusion criteria
    Patients with clinical improvement of symptoms or a clinical course not clear, being treated with other antifungal drugs; patients with intravenous catheter and hospitalized with a diagnosis of fungemia, without clinical symptoms in 12 hours after removal of the catheter; patients with severe deep mycosis with a low probability of clinical efficacy (probability of occurrence with very high death), or severe concomitant diseases or complications that can lead to difficulties in assessing the safety in the treatment in question; Patients with a history of allergy to drugs such as AMPH-B or severe allergic reactions to drugs (shock after administration of several drugs by antifungals); patients with severe hepatic insufficiency, renal, cardiac or pulmonary disease or with the basic function test of body meeting the following criteria: - AST (GOT) or ALT (GPT) greater than 5 times the upper limit of normal or 200 IU / L; - Serum creatinine greater than 2.0 mg / dl; - Proteinuria (qualitative test) 3 + or higher, or total urinary excretion of protein (quantitative test) of 3.5 g / day or higher; - Hyperkalemia or hypokalemia, or baseline level of sodium of 6.0 mEq / L or greater or less than 2.5 mEq / L; - Hyperlipidaemia with a baseline total cholesterol greater than 1.5 times the upper limit of normal or 300 mg / dl, triglycerides greater than 2 times the upper limit of normal or 300 mg / dl; Patients who require an infusion of leukocytes; patients with arterial thrombosis or coagulation with severe dysfunction; patients with diabetes mellitus associated with ketosis; Women who are pregnant or wish to become pregnant, women in puerperium,breastfeeding women; Patients who have participated in a clinical study (with any kind of drugs including anticancer drugs) or who were enrolled for clinical observational studies with pharmaceutical agents in the previous month before the start of treatment with SPK-843; Patients who were not judged by the investigator to be eligible enrolled in the study in question.
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of clinical response based on the total global secondary end points 1 to 6 at the end of treatment (Study Day 14) and the final study visit - follow up - (Study Day 28), compared to the initial clinical status. The assessment will be based on improvement / normalization on a semi-quantitative scale to 3.4 and 5 items or assessed as positive for at least 3 of the first 6 secondary end points
    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 Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 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 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 years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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 state10
    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 Decision2009-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-08-06
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