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    EudraCT Number:2014-001647-20
    Sponsor's Protocol Code Number:WeCabE
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-09-16
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-001647-20
    A.3Full title of the trial
    Weekly cabazitaxel in elderly MCRPC (Metastatic Castration Resistant Prostate Cancer) patients progressing after docetaxel treatment: a phase II study
    Cabazitaxel settimanale nei pazienti anziani con MCRPC (cancro della prostata metastatico resistente alla castrazione) in progressione dopo trattamento con docetaxel: uno studio di fase II
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Weekly cabazitaxel chemotherapy in elderly patients with advanced prostate cancer resistant to previous docetaxel treatment
    Terapia con cabazitaxel settimanale nei pazienti anziani con cancro della prostata metastatico in progressione dopo trattamento con docetaxel
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberWeCabE
    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 SponsorGIOGer (Gruppo Italiano di Oncologia Geriatrica)
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSanofi-Aventis
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale San Giacomo Novi Ligure
    B.5.2Functional name of contact pointSOS Oncologia
    B.5.3 Address:
    B.5.3.1Street AddressVia E. Raggio 12
    B.5.3.2Town/ cityNovi Ligure
    B.5.3.3Post code15067
    B.5.4Telephone number+390143332421
    B.5.5Fax number+390143332327
    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. name Jevtana
    D. of the Marketing Authorisation holderSanofi Aventis Groupe
    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 and solvent for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Castration resistant metastatic prostate cancer progressing after docetaxel based treatment
    Cancro della prostata in fase metastatica e resistente alla castrazione in progressione dopo terapia con docetaxel
    E.1.1.1Medical condition in easily understood language
    Advanced prostate cancer resistant to previous chemotherapy with docetaxel
    Cancro della prostata in fase metastatica e resistente alla castrazione in progressione dopo terapia con docetaxel
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10062904
    E.1.2Term Hormone-refractory 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
    The primary objective of the trial is to evaluate the activity of cabazitaxel in terms of improvement of progression free survival (PFS, defined as a composite endpoint) after 3 months of treatment in elderly patients progressing after a previous docetaxel-based chemotherapy
    L'obiettivo primario dello studio consiste nel valutare l'attività del cabazitaxel in termini di miglioramento della sopravvivenza libera da malattia (PFS, definita come endpoint) dopo 3 mesi di trattamento in pazienti anziani in progressione dopo terapia con docetaxel
    E.2.2Secondary objectives of the trial
    Secondary objectives are: biochemical response, overall survival (OS), treatment toxicity and geriatric assessment
    Obiettivi secondari sono: valutazione della risposta biochimica, della sopravvivenza globale (OS), della tossicità e dell’impatto della terapia sullo stato funzionale dell’anziano
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Metastatic castration-resistant disease with documented clinical (imaging) and/or biochemical progression (PSA increasing* values) during or after a previous docetaxel-based chemotherapy;
    •Testosterone level within castration range (levels <50 ng/dl);
    •Life expectancy ≥ 3 months;
    •G8 Score ≥8 and ≤14 ;
    •ANC ≥ 1.5 x 109/L; PLT ≥ 100 x 109/L; Hb ≥10 g/dl;
    •Serum total bilirubin ≤ UNL;
    •AST/SGOT and ALT/SGPT ≤1.5 times UNL;
    •ALAT and creatinine ≤1.5 times UNL (in case of limit values of serum creatinine, creatinine clearance calculated by CKD-EPI formula should be ≥60 ml/min);
    •Patients must be accessible for treatment and follow up;
    •Age ≥ 70 years.
    *at least two consecutive rises in PSA (with an increase in the absolute-value of at least 2 ng/ml), to be documented over a reference value. PSA measures should be taken at least 2 week apart. In the case the second PSA measure was less than the first increase, a third confirmatory measure (this measure has to be greater than the first PSA rise) is required to be taken.
    • Malattia metastatica resistente alla castrazione documentata in progressione clinico-strumentale e/o biochimica (incremento dei valori* del PSA) durante o dopo una precedente chemioterapia a base di docetaxel;
    • Livello di testosteronemia indicativo di una situazione di castrazione (< 50 ng/dl);
    • Aspettativa di vita ≥ 3 mesi;
    • G8 Score ≥8 e ≤14 ;
    • Conta dei neutrofili ≥ 1.5 x 109/L; conta delle piastrine ≥ 100 x 109/L; Hb ≥10 g/dl;
    • Bilirubina totale sierica ≤ al limite massimo del range di normalità;
    • AST/SGOT e ALT/SGPT ≤1.5 volte il limite massimo del range di normalità;
    • Creatinina sierica ≤1.5 volte il limite massimo del range di normalità; (nel caso di valori limite della creatinina sierica la clearance della creatinina calcolata con la formula CDK-EPI dovrà essere > 60 ml/min;
    • Accessibilità dei pazienti al trattamento ed al follow up;
    • Età ≥ 70 anni.
    *dovranno essere documentati almeno due incrementi consecutivi del PSA al di sopra del valore di riferimento (con un incremento in assoluto di almeno 2 ng/ml). Le determinazioni del PSA dovranno essere effettuate a distanza di almeno 2 settimane. Nel caso in cui la seconda determinazione del PSA fosse inferiore rispetto alla prima sarà necessaria una terza determinazione per conferma (questa determinazione dovrà documentare un valore del PSA superiore rispetto al primo incremento).
    E.4Principal exclusion criteria
    •Age ≥ 85;
    •G8 score < 8 or > 14
    •Ventricular injection fraction < 50%;
    •Any of concomitant serious respiratory or cardiovascular diseases;
    •Active coronary artery disease, uncontrolled hypertension;
    •Any contraindications for administration of corticosteroids or premedication used for cabazitaxel infusion;
    •History of severe hypersensitivity reaction (≥grade 3) to docetaxel and polysorbate 80 containing drugs;
    •Significant neurological or psychiatric disorders;
    •Previous Isotope treatment within 28 days prior to enrolment;
    •Concomitant treatment with other experimental drug, ketoconazole or itraconazole or any other anti-cancer therapy (except for LHRH agonists/antagonists). Other anticancer therapy stopped at least 28 days prior enrolment;
    •Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus);
    •Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a two weeks wash-out period is necessary for patients who are already on these treatments);
    •ECOG performance status >2
    • Età ≥ 85 anni;
    • G8 score < 8 o > 14
    • Frazione di eiezione ventricolare < 50%;
    • Qualsiasi patologia respiratoria o cardiovascolare grave;
    • CAD (arteriopatia coronarica) attiva, ipertensione arteriosa non controllabile;
    • Qualsiasi controindicazione per la somministrazione di corticosteroidi o farmaci utilizzati nella premedicazione per l’infusione del cabazitaxel;
    • Anamnesi positiva per severa reazione allergica (> a grado 3) al docetaxel ed a farmaci contenenti polisorbato 80;
    • Significativi disordini neurologici o psichiatrici;
    • Pregresso trattamento con isotopo (non meno di 28 giorni prima dell’arruolamento);
    • Trattamento concomitante con altri farmaci sperimentali, ketoconazolo od itraconazolo o qualsiasi altra terapia antineoplastica (eccetto LHRH agonisti/antagonisti). Altre terapie antineoplastiche dovranno essere state concluse almeno 28 giorni prima dell’arruolamento;
    • Malattie gravi o situazioni patologiche non controllabili (incluso il diabete mellito scompensato);
    • Trattamento concomitante o programmato con forti inibitori del citocromo P450 3A4/5 (sarà necessario un periodo di “wash-out” di almeno due settimane per i pazienti eventualmente già in trattamento con tali farmaci);
    ECOG performance status >2.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is a composite progression free survival (PFS) endpoint defined as the occurrence of any of the following events: tumor progression based on RECIST criteria; bone progression when 2 or more new lesions; pain progression based on PPI test; death from of any cause.
    Come endpoint primario viene considerata la sopravvivenza libera da progressione (PFS),definita come il manifestarsi di uno dei seguenti eventi: progressione tumorale basata sui criteri RECIST; progressione ossea, in presenza di 2 o più nuove lesioni; progressione del dolore in base al test PPI; morte per qualsiasi causa
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Baseline
    - Every 3 cycles (15 weeks)
    - At the end of the treatment
    - During the follow-up phase every 3 months
    - Basale
    - Ogni 3 cicli (15 settimane)
    - Alla fine del trattamento
    - Durante il follow-up ogni tre mesi
    E.5.2Secondary end point(s)
    The secondary endpoints are: biochemical Response (defined as a reduction from baseline PSA level of at least 50%, maintained for at least 3 weeks); ORR by Recist criteria V1.1; overall survival (OS); close monitoring of toxicity using the NCICTC- AE version 4.03; evaluation of geriatric assessment using the Minimal Data Set (MDS) according to the Elderly Task Force (ETF) EORTC:
    - Charlson comorbidity index;
    - G8 geriatric assessment screening tool;
    - Instrumental activities of daily living (IADL);
    - Social situation.
    Come end points secondari vengono considerati: risposta biochimica (definita come una riduzione del valore del PSA di almeno il 50%, mantenuta per almeno 3 settimane); ORR secondo i criteri Recist; sopravvivenza globale (OS); stretto monitoraggio della tossicità utilizzando i criteri della NCICTC- AE version 4.03; valutazione geriatrica utilizzando il Minimal Data Set (MDS) secondo l'Elderly Task Force (ETF) EORTC:
    - Charlson comorbidity index;
    - G8 geriatric assessment screening tool;
    - Instrumental activities of daily living (IADL);
    - Social situation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Biochemical Response (every 10 weeks/2 cycles); ORR by Recist criteria (every 15 weeks); overall survival (OS); close monitoring of toxicity using the NCICTC- AE version 4.03; evaluation of geriatric assessment (baseline, during treatment, end of treatment) using the Minimal Data Set (MDS) according to the Elderly Task Force (ETF) EORTC:
    - Charlson comorbidity index;
    - G8 geriatric assessment screening tool;
    - Instrumental activities of daily living (IADL);
    - Social situation.
    Risposta biochimica (ogni 10 settimane/due cicli);
    ORR in base ai criteri Recist (ogni 15 settimane); stretto monitoraggio della tossicità utilizzando la NCICTC - AE version 4.03; valutazione geriatrica (al basale, durante il trattamento, alla fine del trattamento) usando il Minimal Data Set dell'Elderly Task Force (ETF) EORTC:
    - Charlson comorbidity index;
    - G8 geriatric assessment screening tool;
    - Instrumental activities of daily living (IADL);
    - Social situation.
    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 No
    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. 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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 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 concerned7
    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 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
    Ultima visita dell'ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    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 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) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 62
    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 Yes
    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 Yes
    F. of other specific vulnerable populations
    Patients over 75 with metastatic castration resistant prostate cancer and G8 Score ≥8 and ≤14
    Pazienti con cancro della prostata metastatico resistente alla castrazione con G8 Score ≥8 e ≤14
    F.4 Planned number of subjects to be included
    F.4.1In the member state62
    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)
    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 Decision2014-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-13
    P. End of Trial
    P.End of Trial StatusOngoing
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