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    Summary
    EudraCT Number:2006-000137-35
    Sponsor's Protocol Code Number:ML19535
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-02-27
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2006-000137-35
    A.3Full title of the trial
    Prospective controlled clinical trial of metastatic breast cancer treatment with capecitabine/docetaxel in combination with beta epoetin as compared with sole capecitabine/docetaxel treatment
    A.4.1Sponsor's protocol code numberML19535
    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 SponsorUAB "Roche Lietuva"
    B.1.3.4CountryLithuania
    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 Information not present in EudraCT
    D.2.1.1.1Trade name NeoRecormon
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 ITW UK
    D.2.1.2Country which granted the Marketing AuthorisationLithuania
    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 nameNeoRecormon
    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 IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNepoetin beta
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30000
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 with metastacic breast cancer disease and anemia
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to compare response to treatment and time to disease progression in patients with metastatic breast cancer, which have detected Hb levels ≤110g/l and are treated with capecetabine/docetaxel with or without epoetin beta.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Form of informed individual consent signed prior to applying any specific trial selection procedure
    2. Patients willing and capable to follow the requirements indicated in the protocol
    3. Patients older than 18 years
    4. Histologically confirmed metastatic breast carcinoma
    5. Patients having no contraindications against capecitabine/docetaxsel treatment
    6. Hb ≤ 110g/l
    7. Grade according to ECOG Performance Status: 0-2
    8. Estimated term of life ≥ 6 months
    9. Agreement of pre-menopausal patients to use contraceptives during the trial terms
    E.4Principal exclusion criteria
    1. Other malignant tumours during the last 5 years (other than completely treated basal cells and (or) squamous cell skin carcinoma (or) squamous cell skin carcinoma and (or) cervical in situ carcinoma)
    2. Pregnancy (positive serum pregnancy test) and breast feeding
    3. Earlier or detected during inspection disease of CNS (e.g., primary brain tumour, seizures not controllable by standard drug medication, any brain metastases)
    4. Clinically significant heart disease, not controllable by drug medication:
    4.1. Heart insufficiency, symptomatic coronary heart disease or heart arrhythmia (NYHA class 3 or 4, see. Appendix III)
    4.2. Myocardial infarction during the last 12 months
    4.3. Treatment resistant hypertension
    5. Peripheral neuropathy ≥ 1 grade
    6. Transfusion of erythrocyte mass during the last month prior to involvement into clinical trial
    7. Anaemia not related directly to chemotherapy and (or) tumour itself
    7.1. Iron deficiency anaemia (Fe < LLN or feritine <10 µg/l), which can not be corrected with iron supplements
    7.2. Vitamin B12 deficiency anaemia (MCV >105 fL and/or vitamin B12 concentration < LLN), which can not be corrected with vitamin B12
    7.3. Folic acid deficiency anaemia (MCV >105 fL and/or folic acid concentration < LLN), which can not be corrected with folic acid preparations
    7.4. Haemolytic anaemia (laboratory indications of haemolysis: reticulocytes > ULN and indirect bilirubine >ULN ± LDH > ULN)
    8. Any laboratory indication value as given below:
    8.1. General blood test: number of neutrophils < 1,5 x 109/l, number of thrombocites < 50 x 109/l,
    8.2. Biochemical blood test: total bilirubine > 1,5 x upper norm limit (ULN), ASAT, ALT > 2,5 x ULN, alkaline phosphatase > 2,5 x ULN, serum creatinine > 1,5 x ULN or creatinine clearance ≤ 50 ml/min (calculated according to Cockroft and Gault formula or formula presented in the internet web page: http://www.globalrph.com/crcl.htm)
    9. Present or recent (28 days prior to randomisation) uptake of another trial drug or participation in another clinical trial
    10. Thrombophylia detected by anamnesis and/or clinically confirmed deep venous thrombosis
    11. Acute or chronic bleeding requiring treatment during the last month
    E.5 End points
    E.5.1Primary end point(s)
    - objective response to treatment, based on tumor evaluation by criteria. Response to treatment is considered like partial remission (PR), complete remission, stable disease (SD), progressive disease (PD);
    - time to disease progression
    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 Information not present in EudraCT
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    other treatment regimen
    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.8.5The 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 Information not present in EudraCT
    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 years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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 Information not present in EudraCT
    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 2006-02-27. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state60
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 60
    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)
    no
    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 Decision2006-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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