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    Summary
    EudraCT Number:2010-022064-12
    Sponsor's Protocol Code Number:EFC11784-FIRSTANA
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-09
    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 number2010-022064-12
    A.3Full title of the trial
    Randomized, Open Label, Multi-Center Study comparing Cabazitaxel at 25 mg/m2 and at 20 mg/m² in Combination with Prednisone Every 3 Weeks to Docetaxel in Combination with Prednisone in Patients with Metastatic Castration Resistant Prostate Cancer not Pretreated with Chemotherapy
    Studio multicentrico, randomizzato, in aperto di Cabazitaxel alla dose di 25 mg/m² e 20 mg/m² ,in associazione a Prednisone ogni 3 settimane in confronto a Docetaxel/Prednisone in pazienti affetti da carcinoma prostatico metastatico resistente alla castrazione, non precedentemente trattati con chemioterapia.
    A.3.2Name or abbreviated title of the trial where available
    FIRSTANA
    FIRSTANA
    A.4.1Sponsor's protocol code numberEFC11784-FIRSTANA
    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 Sponsorsanofi-aventis R&D
    B.1.3.4CountryFrance
    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 supportSANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSANOFI-AVENTIS SPA.
    B.5.2Functional name of contact pointCONTACT POINT
    B.5.3 Address:
    B.5.3.1Street AddressVIALE BODIO, 37/B
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number800.226343
    B.5.5Fax number02.3939.4168
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi-aventis.com
    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 JEVTANA
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCABAZITAXEL
    D.3.9.1CAS number 183133-96-2
    D.3.9.2Current sponsor codeXRP6258
    D.3.9.3Other descriptive nameXRP6258
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number40
    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 No
    D.IMP: 2
    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 JEVTANA
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCABAZITAXEL
    D.3.9.1CAS number 183133-96-2
    D.3.9.2Current sponsor codeXRP6258
    D.3.9.3Other descriptive nameXRP6258
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number40
    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 No
    D.IMP: 3
    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 Yes
    D.2.1.1.1Trade name TAXOTERE*INFUS FL 160MG/8ML
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDocetaxel
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number20
    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 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
    metastatic Castration Resistant Prostate cancer
    carcinoma prostatico metastatico resistente alla castrazione
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    Carcinoma della prostata
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    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 demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m² (Arm A) or 20 mg/m² (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in patients with metastatic castration resistant prostate cancer (MCRPC) and not previously treated with chemotherapy
    Dimostrare la superiorita` di cabazitaxel alla dose di 25 mg/m² (braccio A) o 20 mg/m² (braccio B), in associazione a Prednisone verso docetaxel in associazione a prednisone (braccio C) in termini di sopravvivenza generale (OS) in pazienti con carcinoma prostatico metastatico resistente alla castrazione (mCRPC) non precedentemente trattato con chemioterapia.
    E.2.2Secondary objectives of the trial
    * Evaluate safety in the 3 treat.arms * Compare efficacy of cabazitaxel at 20 mg/m² and 25 mg/m² to docetaxel for: - PFS defined as the first occurrence of any of the foll.events: tumor progression per Response Evaluation Criteria In Solid Tumors (RECIST 1.1), PSA progression, pain progression or death due to any cause - Tumor progression free survival defined as the first occurrence of any of the foll. events: tumor progression per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) or death due to any cause - Tumor response in pts with measurable disease (RECIST 1.1). - PSA response - PSA-Progression free survival (PSA-PFS). - Pain response in pts. with stable pain at baseline. - Pain progression free survival - Time to occurrence of any skeletal related events (SRE). * To compare Health-Related Quality of Life * To assess the PK and PGX of cabazitaxel
    •Confrontare la sicurezza nei 3 bracci di tratt. •Valutare l’efficacia di cabazitaxel alla dose di 20mg/m² o 25mg/m² verso docetaxel in merito a : - PFS definita come 1°evento tra: progressione tumorale secondo i criteri RECIST 1.1 , progressione del PSA, progressione del dolore o decesso per qualsiasi causa. -Sopravvivenza libera da progressione tumorale definita come 1° evento tra:progressione tumorale secondo i criteri RECIST 1.1 o decesso per qualsiasi causa. -Risposta tumorale in pz con lesioni misurabili (RECIST 1.1.)-Sopravvivenza libera da progressione del PSA-Risposta al dolore-Sopravvivenza libera da progressione del dolore-Tempo di comparsa di ogni evento correlato all’apparato scheletrico(SRE)• Paragonare la qualita`della vita relativa alla salute- Valutare la PK e la PGX di cabazitaxel.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Histologically- or cytologically-confirmed prostate adenocarcinoma. 2.Metastatic disease. 3.Progressive disease while receiving hormonal therapy or after surgical castration documented
    I 01. Diagnosi di Adenocarcinoma prostatico confermata istologicamente o citologicamente. I 02. Malattia metastatica I 03. Progressione della malattia durante la terapia ormonale o dopo la castrazione chirurgica documentata.
    E.4Principal exclusion criteria
    Prior chemotherapy for prostate cancer, * Less than 28 days elapsed from prior treatment with estramustine, radiotherapy or surgery to the time of randomization. . * Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to > 30% of bone marrow. * Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization. * Less than 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status > 2. leptomeningeal disease. * Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization. Any severe acute or chronic medical condition which could impair the ability of the patient to participate to the study or interfere with interpretation of study results or patients unable to comply with the study procedures. Absence of signed and dated Institutional Review Board (IRB)-approved patient informed consent form prior to enrollment into the study. * Patients with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period. * Inadequate organ and bone marrow function
    E 01. Precedente chemioterapia per il tumore alla prostata, E 02. Meno di 28 gg tra la randomizzazione ed un precedente trattamento con estramustina, radioterapico o chirurgico. E 03. Trattamento precedente con isotopi, radioterapia pelvica completa o radioterapia del midollo osseo &gt;30%.E 04.Eventi avversi (ad eccezione dell’alopecia e di quelli elencati tra i criteri di esclusione specifici) dovuti a qualsiasi tipo di terapia antitumorale precedente, di grado &gt;1 (National Cancer Institute Common Terminology Criteria [NCI CTCAE], versione 4.03) al momento della randomizzazione.E 05. Eta` inferiore ai 18 anni. E 06. ECOG (Eastern Cooperative Oncology Group) performance status &gt; 2. E 07. malattia leptomeningea. 08.Partecipazione ad altri studi clinici e qualsiasi trattamento concomitante con altri farmaci sperimentali nei 30 giorni precedenti la randomizzazione. E09 Altre condizioni mediche gravi, acute o croniche, che possano limitare la capacita` del paziente di partecipare allo studio o che possano interferire con l’interpretazione dei risultati dello studio o pz incapaci di osservare le procedure dello studio. E 10. Assenza di un consenso informato del paziente approvato dal Comitato Etico del centro firmato e datato prima dell’arruolamento nello studio. E 11. Pz in eta` fertile che non accettino di utilizzare un metodo di contraccezione approvato ed efficace durante il periodo di trattamento sperimentale. E 12. Inadeguata funzionalita` d’organo e midollare.
    E.5 End points
    E.5.1Primary end point(s)
    OS defined as the time interval from the date of randomization to the date of death due to any cause
    Sopravvivenza globale (OS) definita come l’ intervallo di tempo compreso tra la randomizzazione e la data del decesso dovuto a qualsiasi causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 12 weeks until study cut off date
    Ogni 12 settimane fino alla datd di cut off dello studio.
    E.5.2Secondary end point(s)
    Progression-free survival - Tumor response in patients with measurable disease (RECIST) - PSA response - PSA Progression - Pain response - Pain Progression - Health-Related Quality of Life (HRQL) - Related skeletal events - Safety (NCI-CTC version 4.03) - Pharmacokinetics and pharmcogenomics - Biomarkers
    Sopravvivenza libera da progressione - Risposta tumorale in pazienti con lesioni misurabili (RECIST) - Risposta del PSA - Progressione del PSA - Risposta al dolore - Progressione del dolore - Qualita' della vita in relazione allo stato di salute - Eventi correlati all`apparato scheletrico - Tollerabilita' (NCI-CTC versione 4.03)- Farmacocinetica e farmacogenomica e biomarcatori.
    E.5.2.1Timepoint(s) of evaluation of this end point
    every 12 weeks for radiological assessment each visit for safety, biology and patient questionnaires
    ogni 12 settimane per la valutazione radiologica, ogni vista per la sicurezza, esami biologici e questionari del paziente.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Brazil
    Canada
    Israel
    Mexico
    Peru
    Russian Federation
    Taiwan
    Turkey
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    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 No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 442
    F.4.2.2In the whole clinical trial 1170
    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 Decision2011-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-03
    P. End of Trial
    P.End of Trial StatusCompleted
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