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    Summary
    EudraCT Number:2005-005581-36
    Sponsor's Protocol Code Number:2005-005581-36/309821
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-07-13
    Trial results View 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2005-005581-36
    A.3Full title of the trial
    Randomized phase II study to investigate the efficacy, safety and tolerability of ZK 230211 (25 mg vs. 100 mg) as second-line endocrine therapy for postmenopausal women with hormone receptor-positive metastatic breast cancer
    Studio randomizzato di fase II per valutare l efficacia, la sicurezza e la tollerabilita` del farmaco ZK 230211 a due dosaggi (100 verso 25 mg) come seconda linea di terapia ormonale nelle donne in post-menopausa con carcinoma metastatico della mammella e positivita` ai recettori ormonali
    A.4.1Sponsor's protocol code number2005-005581-36/309821
    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 SponsorSCHERING
    B.1.3.4CountryItaly
    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 nameZK 230211
    D.3.2Product code SHT00208FA
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHORMONE ANTAGONISTS AND RELATED AGENTS
    D.3.9.2Current sponsor codeZK 230211
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number25
    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 No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 nameZK 230211
    D.3.2Product code SH T00208GA
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHORMONE ANTAGONISTS AND RELATED AGENTS
    D.3.9.2Current sponsor codeZK 230211
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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 No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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
    metastatic breast cancer
    Carcinoma metastatico della mammella
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    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
    To evaluate efficacy (clinical benefit) of two doses of ZK PRA (25 mg and 100 mg) when administered once daily p.o.
    Valutare l'efficacia (in termini di beneficio clinico) di ZK PRA somministrato a due dosaggi (25 versus 100 mg, una volta al giorno per 6 mesi) come trattamento di seconda linea ormonale in pazienti post-menopausa con carcinoma metastatico della mammella e positivita' ai recettori ormonali.
    E.2.2Secondary objectives of the trial
    To evaluate: safety and tolerability; pharmacokinetics of ZK PRA; the effect of ZK PRA on quality of life (QoL); to perform exploratory analysis of biomarkers.
    Valutare: sicurezza e tollerabilita' dei trattamenti sopra indicati con ZK PRA; farmacocinetica di ZK PRA; effetto di ZK PRA sulla qualita' di vita; analisi esplorativa di marcatori molecolari non genetici
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Postmenopausal women defined as: - aged >= 50 years with amenorrhea for at least 12 months or - aged minor/equal 50 years with 6 months of spontaneous amenorrhea and follicle stimulating hormone (FSH) level within postmenopausal range (> 40 mIU/ml) or - having undergone bilateral oophorectomy 2. Histologically or cytologically confirmed breast cancer 3. Metastatic breast cancer (Stage IV according to UICC - Union Internationale Contre Cancer - criteria, Version 6) 4. Progesterone receptor-positive tumors 5. Patients must be considered candidates for endocrine therapy (no other therapies for breast cancer are required) 6. Disease progression after first-line endocrine therapy for advanced breast cancer (i.e. with tumor remission or stabilization lasting at least 3 months under endocrine therapy) 7. At least one measurable or non-measurable tumor lesion (according to RECIST criteria) 8. WHO Performance status <= 2 9. Adequate function of major organs and systems • Hematopoietic: - Hemoglobin: >= 10 g/dL - Absolute neutrophil count: >= 1,500/mm3 - Platelet count: >= 100,000/mm3 • Hepatic: - Total bilirubin: <= 1.5 times the upper limit of normal - AST/ALT: <= 2.5 times the upper limit of normal • Renal: - Creatinine: <= 1.5 times the upper limit of normal • Gynecological: - Normal endometrial thickness (in non-hysterectomized women) No other uncontrolled concurrent illness 10. Adequate recovery from previous surgery, radiation and chemotherapy 11. Written informed consent
    1. Donne in post-menopausa definite come: - eta' maggiore/uguale 50 anni con amenorrea da almeno 12 mesi o - eta' minore/uguale 50 anni con amenorrea spontanea da almeno 6 mesi e livelli di ormone follicolo stimolante (FSH) entro i range post-menopausa (&gt; 40 mIU/ml) o - ovarioectomia bilaterale in anamnesi 2. Diagnosi istologica o citologica di carcinoma della mammella 3. Carcinoma metastatico della mammella (Stadio IV secondo UICC - Union Internationale Contre Cancer - criteria, Version 6) 4. Tumore positivo per il recettore del progesterone 5. Pazienti considerate candidate per la terapia endocrina (non devono essere ritenute necessarie altre terapie per il carcinoma della mammella) 6. Progressione di malattia dopo una prima linea di terapia endocrina per il tumore metastatico della mammella (deve essere stata riportata remissione del tumore o stabilita' di malattia per almeno 3 mesi di terapia endocrina precedente) 7. Almeno 1 lesione tumorale misurabile o non misurabile (in accordo ai criteri RECIST) 8. WHO Performance status minore/uguale 2 9. Funzionalita' adeguata dei maggiori organi e sistemi: Sistema Emopoietico: - Emoglobina &gt;= 10 g/dL - Neutrofili &gt;= 1,500/mm3 - Paistrine &gt;= 100,000/mm3 Fegato: - Bilirubina totale: &lt;= 1.5 volte il limite superiore di normalita' (ULN) - AST/ALT &lt;= 2.5 ULN Reni: - Creatinina &lt;= 1.5 ULN Ginecologico: - Spessore endometriale normale (in donne non sottoposte a isterectomia) Assenza malattie concomitanti non controllate. 10. Adeguato recupero da precedente chirurgia, radioterapia e chemioterapia 11. Rilascio del consenso informato scritto
    E.4Principal exclusion criteria
    1. Presence of any of the following conditions: - life-threatening metastatic visceral disease (extensive hepatic involvement) - any metastases to the central nervous system (CNS) - pulmonary lymphangitic metastases involving more than 50% of the lung 2. More than one prior endocrine treatment for advanced breast cancer 3. Malignancies or history of prior malignancy other than carcinoma in situ of the cervix or uterus, or basal and squamous cell carcinoma of the skin 4. Intake of CYP3A4 inhibitors (see Attachment 3) less than 2 weeks before start of study treatment 5. Other investigational drug therapies less than 4 weeks or at least 5 half lives before start of study treatment 6. Expectation that the patient will not be able to complete at least 3 months of therapy 7. Unwillingness or inability to comply with the protocol
    1. Presenza di qualsiasi delle condizioni seguenti: - malattia metastatica viscerale che metta la paziente in pericolo di vita (coinvolgimento epatico esteso) - qualsiasi metastasi al sistema nervoso centrale (CNS) - metastasi polmonari linfangitiche che coinvolgano piu' del 50% del polmone 2. Piu' di una precedente terapia endocrina per carcinoma metastatico della mammella 3. Forme tumorali concomitanti o precedenti ad eccezione del carcinoma in situ della cervice o dell'utero, o carcinoma della pelle a cellule basali e squamose. 4. Assunzione di inibitori del citocromo CYP3A4 entro due settimane prima dell'inizio della terapia sperimentale (Vedere allegato 3 del protocollo) 5. Trattamento con un farmaco sperimentale nelle ultime 4 settimane o almeno nelle 5 emivite del farmaco prima dell'inizio del trattamento in studio 6. Attesa che la paziente non sia in grado di completare almeno 3 mesi terapia sperimentale 7. Mancanza di volonta' o incapacita' della paziente ad attenersi alle procedure previste da protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    • Clinical Benefit (CB): proportion of patients with: - Complete response (CR) or partial response (PR) at any time point or - Stable disease (SD) for 6 months from the start of study treatment
    Beneficio Clinico (CB), ovvero la proporzione di pazienti con Risposta Completa (CR) o Risposta Parziale (PR), in qualsiasi momento o con Stabilita' di Malattia (SD) per almeno 6 mesi dall'inizio del trattamento sperimentale.
    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 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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    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 months12
    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.1.1Number of subjects for this age range: 0
    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 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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 72
    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)
    Tutti i pazienti che rilasceranno il consenso verranno arruolati in studio di follow-up (prot. 310381). I pazienti con risposta completa, risposta parziale o stabilita' di malattia potrebbero continuare la terapia sperimentale. Tutti gli altri pazienti potrebbero ricevere terapie alternative e saranno seguito per un follow-up di sopravvivenza.
    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 Decision2007-12-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-01-29
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