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    Summary
    EudraCT Number:2007-000841-36
    Sponsor's Protocol Code Number:PS76A2.25
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-08-18
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2007-000841-36
    A.3Full title of the trial
    Multicenter, randomized, double-blind, placebo-controlled parallel group study to demonstrate the efficacy (quality of life) and safety of the standardized mistletoe extract PS76A2 during chemotherapy and follow-up in patients with breast cancer
    A.4.1Sponsor's protocol code numberPS76A2.25
    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 SponsorRottapharm Madaus, Madaus GmbH
    B.1.3.4CountryGermany
    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 Yes
    D.2.1.1.1Trade name Lektinol
    D.2.1.1.2Name of the Marketing Authorisation holderMadaus GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameLektinol
    D.3.2Product code PS76A2
    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 IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmistletoe extract
    D.3.10 Strength
    D.3.10.1Concentration unit ng nanogram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 Yes
    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
    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 placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Female patients with breast cancer shortly after surgery [pTNM classification: pT1-T4, pN0-N+ (0-9 positive lymph nodes), pM0] qualified for adjuvant chemotherapy according to FEC scheme as standard of care
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10057654
    E.1.2Term Breast cancer female
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to investigate the influence of PS76A2 on quality of life in patients with breast cancer receiving adjuvant chemotherapy quantified by FACT-G questionnaire.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to investigate the effect of PS76A2 on QoL quantified by GLQ-8, Spitzer's uniscale, FACT-B (i.e. FACT-G including additional concerns for patients with breast cancer), and EORTC QLQ-C30 as well as the effect of PS76A2 on the course of chemotherapy, on the hematological profile, and on safety variables.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Female patient
    2) Postsurgical condition of breast cancer with TNM classification
    - pT1mic, pT1a, 1b, 1c, 2, 3 or 4
    - pN0, pN+ with a maximum of 9 positive axillar lymph nodes
    - pM0
    3) Patient is eligible for adjuvant chemotherapy according to the following scheme as standard of care: FEC (minimum three to maximum six 3-week cycles)
    4) Pre- or postmenopausal state
    5) Age between 18 and 60 years (18 and 70 years included).
    6) School education > 7 years
    7) Oral and written informed consent to participate in the study according to ICH-GCP and applicable national law
    8) Women of childbearing potential must use at least one highly effective method of birth control during the whole study
    E.4Principal exclusion criteria
    1) Inability to answer the quality of life scales.
    2) Two-sided location of breast cancer at study enrolment.
    3) Carcinoma in situ.
    4) Concomitant malignancy at study enrolment.
    5) Administration of prohibited concomitant medication at study enrolment. Note: The use of prohibited drugs during the study will induce the exclusion from the per protocol population.
    6) Radiation therapy prior to or at study enrolment in a total dose of > 60 Gy. Note: The administration of radiation therapy during the study period is allowed as long as the total dose does not exceed 60 Gy.
    7) Deviation from the planned course of screening period:
    - Interval between surgery and first day of chemotherapy (= Day 1; = S2) greater than 70 days
    - Interval between surgery and first day of chemotherapy less than 15 days
    - Interval between S0 and first day of chemotherapy less than 14 days
    - Screening Visit S1 outside Day –7 (± 1 day)
    - Screening Visit S2 outside Day 1

    8) Known hypersensitivity to protein or mistletoe preparations
    9) Chronic progressive infections (e.g. tuberculosis).
    10) Auto-immune diseases
    11) Alcohol abuse (> 50 g ethanol per day).
    12) Nicotine abuse (> 20 cigarettes per day).
    13) Pregnancy or breast feeding.
    14) Participating in another clinical trial within 30 days before study enrolment, or concurrent participating in another clinical trial.
    15) Other circumstances that make the investigator expect an incomplete study participation of the patient (e.g. planned removal).
    16) Cancellation of informed consent to participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The aim of the primary statistical analysis is to prove the superiority of PS76A2 ('active') to 'placebo' in patients with breast cancer receiving adjuvant chemotherapy with regard to QoL measurements by means of FACT-G. The primary endpoint is a cumulated change variable based on differences versus baseline (S1, S2, S3) after 4 (3-week) chemotherapy cycles.
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months20
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months20
    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 No
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 320
    F.4.2.2In the whole clinical trial 320
    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 termination of the study the patient will be treated by the physician according to usual care in the respective study center.
    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 Decision2009-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-08
    P. End of Trial
    P.End of Trial StatusOngoing
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