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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-000782-35
    Sponsor's Protocol Code Number:28-02 (ZKS000429)
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-01-27
    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 number2008-000782-35
    A.3Full title of the trial
    Dose-escalating study to determine the maximum tolerated dose (MTD) of the mistletoe extract WEME 200 mg for intravesical instillation in patients with completely resected (R0) superficial bladder carcinoma (pTa low grade [multilocular or recurrence], pT1 low grade)
    A.3.2Name or abbreviated title of the trial where available
    Intravesical instillation of mistletoe extract (WEME 200 mg) in superficial bladder carcinoma
    A.4.1Sponsor's protocol code number28-02 (ZKS000429)
    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 SponsorVerein fuer Krebsfoschung (Society for Cancer Research)
    B.1.3.4CountrySwitzerland
    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.3.1Product nameWEME 200 mg
    D.3.2Product code WEME 200 mg
    D.3.4Pharmaceutical form Solution for intravesical use
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 8500009178
    D.3.9.2Current sponsor codeWEME 200 mg
    D.3.9.3Other descriptive nameMISTLETOE EXTRACT
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number75,6 to 104,4
    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) 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 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
    Patients after transurethral R0-resection (TUR) of a histologically confirmed superficial bladder carcinoma (pTa low grade [multilocular or recurrence], pT1 low grade); re-resections included.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10046518
    E.1.2Term Urinary bladder carcinoma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the maximum tolerated dose (MTD) of a mistletoe-extract (oak) manufactured by WELEDA (WEME 200 mg) in intravesical instillation in the selected patient population, based on the incidence of dose-limiting toxicities (DLTs), to describe the optimal dose ranges for putative phase II/III trials.
    E.2.2Secondary objectives of the trial
    1. To investigate safety and tolerability of different dosages of intravesically applied mistletoe extract (WEME 200 mg).

    2. To acquire first data about the clinical effects of intravesical instillation of WEME 200 mg in superficial bladder carcinoma.
    - To describe tumor recurrence rate 3, 6, 9 and 12 months after start of therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age: 18 - 80 years.
    2. Histologically confirmed superficial bladder carcinoma: pTa low grade [multilocular or recurrence] or pT1 low grade; re-resected tumours included.
    3. No evidence of lymph node involvement and/or metastasis.
    4. Transurethral R0-resection of the bladder tumour and immediate instillation of mitomycin C (dosage and administration according to respective SmPC) within 2 - 7 weeks before inclusion into the study; re-resection of the tumour included.
    5. Patient information according to applicable national legislation and international guidelines followed by signing and dating the informed consent form.
    6. Female, pre-menopausal patients must provide negative pregnancy test within two weeks before study entry and are willing to apply a highly effective birth-control method.
    E.4Principal exclusion criteria
    1. Bladder carcinomas with one or more of the following characteristics: Carcinoma in situ (pTis), pT2-4, N1-3, M1, G3-4; furthermore are excluded pTa-tumours with low grade-grading which are not multilocular or recurrent.
    2. Previous intravesical instillation therapy within the last 6 months (except previous immediate instillation of mitomycin C at day of transurethral R0-resection).
    2.b Secondary damage of previous administration of intravesical chemotherapy, e.g. necrosis of urothelium or stenoses.
    3. Previous radiation therapy.
    4. Bladder resection.
    5. Contracted bladder with capacity < 100 ml.
    6. Inadequately treated acute or chronic urinary tracts infections.
    7. Secondary neoplasia.
    8. Co-morbidity with one of the following: active tuberculosis, active thyroid hyperfunction, known secondary cancer, HIV-infection/ AIDS, other severe systemic diseases as cardiac insufficiency, parasitosis or Crohn’s disease, acute inflammatory diseases with body temperature > 38 °C.
    9. Other concomitant diseases likely to make participation of the patient difficult at the discretion of the investigator.
    10. Clinically relevant cardiac arrhythmias.
    11. Severe allergic illness (including asthma); known hypersensitivity to mistletoe products.
    12. Any other current or planned oncological therapy (surgery, radiotherapy, chemotherapy, other mistletoe products including s.c. therapy with Iscador®).
    13. Previous medical therapy that could interfere with the objectives of this study including mistletoe therapy within the last month.
    14. Concomitant treatment with other immunomodulatory medications.
    15. Known abuse of medicaments, alcohol or illegal drugs.
    16.Laboratory parameters outside the following limits:
    Creatinine > 2x upper limit of normal
    Bilirubine > 3x upper limit of normal
    Transaminases > 3x upper limit of normal
    17. Pregnancy or breast-feeding.
    18. Pre-menopausal women not applying an effective birth control method.
    19. Doubt concerning the compliance.
    20. Previous participation in this clinical trial earlier in study course. Participation in any other clinical trial currently or within the last month.
    21. Subjects which are in a state of dependence in relation to the sponsor’s or investigator’s institutions or which are their employees.
    E.5 End points
    E.5.1Primary end point(s)
    Estimation of the MTD (i.e., the highest dose applied provoking a dose-limiting toxicity [DLT] at a probability of maximally 33%) by fitting an a priori set dose-toxicity-relationship model to the observed rate of DLTs according to a modified version of the ‚Continual Reassessment Method (CRM)’.
    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 Yes
    E.6.5Efficacy Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose escalation study
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 concerned2
    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
    Model based dose escalation is stopped either if >= 9 patients were treated on a given dose level and model predicts next patient to be treated at same level; or if actual dose level can be regarded as MTD with a probability of >= 90% (in both cases, actual dose level will be defined as MTD); or if maximum envisaged sample size of 24 patients has been included.
    In any case the last visit of the last patient (last patient: see aforementioned definition) will define the end of the clinical phase.
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state24
    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 study participation the treatment of the patients will be performed according to the applicable clinical standards.
    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 Decision2008-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-04-07
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