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    Summary
    EudraCT Number:2014-002386-30
    Sponsor's Protocol Code Number:33-04
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-12-16
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2014-002386-30
    A.3Full title of the trial
    Efficacy and Safety of Mistletoe Extract in the Palliative Therapy of Patients Suffering from Pancreatic Cancer (PALM-Pan)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Mistletoe Extract in the Palliative Therapy of Patients Suffering from Pancreatic Cancer (PALM-Pan)
    A.4.1Sponsor's protocol code number33-04
    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 SponsorVerein für Krebsforschung
    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 supportVerein für Krebsforschung
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVerein für Krebsforschung
    B.5.2Functional name of contact pointDr. sc. nat. Stephan Baumgartner
    B.5.3 Address:
    B.5.3.1Street AddressKirschweg 9
    B.5.3.2Town/ cityArlesheim
    B.5.3.3Post code4144
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+416170672-31/-30
    B.5.5Fax number+41617067200
    B.5.6E-mails.baumgartner@vfk.ch
    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 Iscador® Qu
    D.2.1.1.2Name of the Marketing Authorisation holderWeleda AG, Switzerland
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 nameFermented aqueous extract of Viscum album ssp album [L.] (mistletoe)
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMISTLETOE EXTRACT
    D.3.9.1CAS number 8500009-17-8
    D.3.9.3Other descriptive nameMISTLETOE EXTRACT
    D.3.9.4EV Substance CodeSUB14585MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.01 to 20
    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) 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 No
    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
    Locally advanced or metastatic adenocarcinoma of the pancreas (UICC stadium III or IV)
    E.1.1.1Medical condition in easily understood language
    Patients Suffering from Pancreatic Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10033604
    E.1.2Term Pancreatic cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the overall survival and the fatigue symptoms of patients who suffer from advanced pancreatic cancer and who will receive additive palliative therapy with mistletoe extract (ME).
    E.2.2Secondary objectives of the trial
    To determine the quality of life and the extent of pain and neutropenia as well as the compatibility of chemotherapy with additive palliative mistletoe therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas (UICC stadium III or IV), histologically confirmed if easily accessible
    2. Age between 18 and 90 years at study enrolment, legal competence
    3. Voluntarily given written informed consent in advance of any study-specific procedure
    4. No pre-treatment with mistletoe extracts
    5. No option for surgical resection or radiation in curative intent at the time of inclusion
    6. Adequate negative pregnancy test and adequate contraception for women of child-bearing age
    7. Scheduled Gemcitabine mono- or Gemcitabine-based combination chemotherapy starting within the next 4 weeks but only after baseline visit
    8. Adequate bone marrow function, assessed by laboratory values (existing results not older than 7 days may be used):
    8.1 Leucocyte count ≥ 3000 / mm3
    8.2 Neutrophil count ≥ 1500 / mm3
    8.3 Platelet count ≥ 100.000 / mm3
    E.4Principal exclusion criteria
    1. Pregnancy or breastfeeding
    2. Terminally ill patients (life expectancy less than 4 weeks)
    3. Previous chemotherapy, other systemic therapy or radiotherapy of the current cancer disease
    4. Significant weight loss (≥ 20% body weight in the preceding 6 weeks)
    5. Current use of immunostimulant or immunosuppressive agents except therapeutics within the routinely administered standard therapy (e.g. corticosteroids for anti-emesis)
    6. Current use of any investigational agent or participation in a clinical trial during the last 4 weeks
    7. Drug abuse, alcohol abuse, methadone treatment
    8. Second primary malignancy in the last 5 years
    9. Known intracranial and spinal tumours and/or metastases
    10. Clinically significant concomitant disease critically influencing the ability of the patient to protocol adequate behaviour
    11. Co-morbidity with one of the following: chronic granulomatous diseases (incl. Tbc), hyperthyroidism with tachycardia, HIV infection/AIDS, other severe systemic diseases such as cardiac insufficienc (NYHA Stadium III - IV), parasitosis or Crohn's disease, acute inflammatory diseases with body temperature > 38°C, and other high febrile or autoimmune diseases
    12. Assured allergy to mistletoe-containing products.
    E.5 End points
    E.5.1Primary end point(s)
    - Overall Survival: time from randomization to death for any reason
    - Fatigue according to FACIT-FATIGUE, assessed every four weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    After completion of study and closure of data base.
    E.5.2Secondary end point(s)
    - Time to definitive deterioration of the Physical Functioning Scale of the EORTC QLQ-C30 by 10 units as assessed by a weekly questionnaire or to death for any reason, whichever occurs first
    - QoL dimensions of the EORTC QLQ-C30 Global Health, Role Functioning, Emotional Functioning, Social Functioning, Cognitive Functioning, Physical Functioning, Nausea/Vomiting, Pain, Insomnia and Appetite Loss, assessed at every study visit except the phone visit
    - pancreatic cancer-specific pain symptoms, assessed by a weekly questionnaire
    - Body weight weekly
    - Rates of moderate and severe/life-threatening neutropenia:
    CTC II (<1500-1000/mm3), CTC III (<1000-500/mm3) / CTC IV (<500/mm3)
    - Frequency of other chemotherapy-induced adverse events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After completion of study and closure of data base.
    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 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 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 Yes
    E.8.1.7.1Other trial design description
    Stratified randomization, according to tumour spreading, separately for every centre
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Control group with no further therapy in addition to chemotherapy
    E.8.2.4Number of treatment arms in the trial2
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Serbia
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    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.1.2.1Number of subjects for this age range: 290
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 290
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 290
    F.4.2.2In the whole clinical trial 290
    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)
    The patients will further receive their standard treatment for their condition.
    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 Decision2015-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-03-25
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