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    Summary
    EudraCT Number:2009-015159-26
    Sponsor's Protocol Code Number:UKW-Inf-001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-11-18
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-015159-26
    A.3Full title of the trial
    UKW-Inf-001: Prospective trial to evaluate pharmacokinetic, safety and efficacy of intermittent application of increased doses of caspofungin for antifungal prophylaxis in high risk patients.
    A.3.2Name or abbreviated title of the trial where available
    CASPHYLAX
    A.4.1Sponsor's protocol code numberUKW-Inf-001
    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 SponsorUniversitaetsklinikum Wuerzburg
    B.1.3.4CountryGermany
    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 Cancidas
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCaspofungin
    D.3.4Pharmaceutical form Powder for concentrate for solution 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.3.8INN - Proposed INNCASPOFUNGIN ACETATE
    D.3.9.1CAS number 179463-17-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prophylaxis of invasive fungal infection, including life-threatening aspergillosis and candidiasis, is investigated in the study. Patient with acute myeloid leukemia or acute lymphatic leukemia will be included in the study during or before induction chemo therapy.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10003488
    E.1.2Term Aspergillosis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10042941
    E.1.2Term Systemic fungal infection NOS
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10007152
    E.1.2Term Candidiasis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10036898
    E.1.2Term Prophylaxis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the pharmacokinetic of caspofungin IV solution in an intermittent
    dosing schedule of 3 times a week after a 3 days loading in a representive subject
    population.
    E.2.2Secondary objectives of the trial
    To prove the pharmacological approach of intermittent dosing, blood samples will be
    analyzed for satisfactory serum concentrations at different time points. The
    differentiated endpoints of fungal infections and overall effectiveness as well as
    tolerability and safety of the drug will be examined in a series of secondary
    objectives.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with acute myeloid leukemia or myelodysplastic syndrome and blast
    crisis or acute lymphatic leukemia
    • The patient is receiving induction chemotherapy, starting within 5 days
    before and 4 days after enrollment.
    • The patient has an expected duration of neutropenia (neutrophils < 500/μl) for
    at least 10 days
    • The patient has no proven or probable invasive Aspergillus infection within
    12 months prior to enrollment
    • For women with childbearing potential, the patient has a negative serum or
    urine pregnancy test within 48 hours of enrollment and the patient agrees to
    use adequate birth control measures as defined by the investigator. Oral
    contraceptives should not be used as the sole method of birth control.
    E.4Principal exclusion criteria
    • The patient received systemic antifungal therapy with liposomal amphotericin
    B, amphotericin B deoxycholate, caspofungin, anidulafungin, micafungin,
    voriconazole, itraconazole or posaconazole (oral or I.V. for the azoles) but
    not fluconazole within 3 days prior to enrollment
    • The patients had a proven or probable invasive Aspergillus infection within
    12 months prior to enrollment.
    • The patient has a possible aspergillosis, due to the following criteria within
    14 days of enrollment:
    o positive galactomannan (OD> 0.5) in serum twice or more times or at
    least one time in bronchioalveolar fluid
    o pulmonary infiltrates in the computer tomography of the chest suspicious
    for fungal infection (positive halo-, air-crescent sign, nodular). Patients
    with pulmonary infiltrates on conventional chest x-ray, should undergo
    further evaluation with a CT scan before enrollment if clinically
    indicated.
    • The patient is participating in another trial with an investigational drug during
    the last 14 days before start of prophylaxis.
    • The patient has a history of allergy, hypersensitivity or any serious reaction to
    caspofungin or any echinocandin.
    • Women, who are pregnant or breastfeeding.
    • The patient has a positive HIV test or known HIV infection
    • The patient has a known drug abuse.
    • The patient’s weight is more than 100 kg
    • The patient has one or more of the following abnormal laboratory values
    - Serum total bilirubin > 5 times upper limit of normal
    - INR > 1.6 (INR > 4.0, if the patient is receiving anticoagulation)
    - Serum ASAT (SGOT) or ALAT (SGPT) > 5 times upper limit of normal
    • The patient is receiving hemodialyses for severe renal failure
    • The patient has a moderate or severe hepatic insufficiency (Child Pugh score
    >6), acute hepatitis or cirrhosis due to any cause
    • The patient has a life expectancy below 5 days
    • The patient is receiving rifampin, cyclosporin A, efavirenz, nevirapine,
    carbamazepine, phenytoin.
    • The patient has any concomitant illness which, in the opinion of the
    investigator, might confuse the results of the study or pose additional risk in
    administering caspofungin to the patient.
    E.5 End points
    E.5.1Primary end point(s)
    Pharmakocinetic of Caspofungin for intermittent dosing including Cmx, Cmin, AUC.
    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 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) 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 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) 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 Information not present in EudraCT
    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
    End of the trial is the last visit of last subject undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years0
    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.1.3Elderly (>=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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-11-18. Yes
    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 state25
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 25
    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)
    After subject has ended participation in the trial, there is no other intervention or treatment, different from the expected normal treatment, planned.
    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 Decision2011-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-14
    P. End of Trial
    P.End of Trial StatusOngoing
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