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    Summary
    EudraCT Number:2016-001179-60
    Sponsor's Protocol Code Number:CABASTY
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-10-02
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-001179-60
    A.3Full title of the trial
    Randomized multicenter, phase III trial evaluating the safety of 2 schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (≥ 65 years) with metastatic castration-resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen.
    Randomisierte multizentrische Phase-III-Studie zur Bewertung der Sicherheit von 2 Cabazitaxel-Studien (alle 2 Wochen und 3 Wochen) plus Prednison bei älteren Männern (≥ 65 Jahre) mit metastasiertem, kastrationsresistentem Prostatakrebs (mCRPC), die zuvor mit Docetaxel behandelt wurden.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the safety of 2 schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (≥ 65 years) with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing regimen
    Bewertung der Sicherheit von 2 Zyklen von Cabazitaxel (alle 2 Wochen oder 3 Wochen) plus Prednison bei älteren Männern (≥ 65 Jahre) mit metastasiertem, kastrationsresistentem Prostatakrebs, die zuvor mit einem Docetaxel behandelt wurde
    A.3.2Name or abbreviated title of the trial where available
    CABASTY
    CABASTY
    A.4.1Sponsor's protocol code numberCABASTY
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1234-7851
    A.5.4Other Identifiers
    Name:DRKSNumber:DRKS00017467
    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 SponsorA.R.T.I.C (Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie)
    B.1.3.4CountryFrance
    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 supportA.R.T.I.C (Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie)
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportSANOFI AVENTIS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationA.R.T.I.C (Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie)
    B.5.2Functional name of contact pointSponsor
    B.5.3 Address:
    B.5.3.1Street AddressService d’Oncologie Médicale, Hôpital Européen Georges Pompidou 20-30, rue Leblanc
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75015
    B.5.3.4CountryFrance
    B.5.4Telephone number0033156092340
    B.5.5Fax number0033156092788
    B.5.6E-mailreza-thierry.elaidi-ext@aphp.fr
    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 Groupe
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameJEVTANA
    D.3.4Pharmaceutical form Concentrate and solvent 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.3.9.1CAS number 183133-96-2
    D.3.9.3Other descriptive nameCABAZITAXEL
    D.3.9.4EV Substance CodeSUB31282
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    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.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 (mCRPC)
    Metastasierter kastrationsresistenter Prostatakrebs (mCRPC)
    E.1.1.1Medical condition in easily understood language
    Metastatic castration-resistant prostate cancer
    Metastasierter kastrationsresistenter Prostatakrebs
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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 evaluate the incidence of grade ≥ 3 neutropenia (measured at Day 7 and Day 14) and/or neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (≥ 65 years) with mCRPC previously treated with a docetaxel-containing regimen.
    Die Überprüfung der Häufigkeit von Grad ≥ 3 Neutropenie (gemessen am Tag 7 und Tag 14) und / oder neutropenischen Komplikationen (febrile Neutropenie, neutropenische Infektion) mit zwei verschiedenen Zyklen Cabazitaxel (alle zwei Wochen versus drei Wochen) plus Prednison bei älteren Männern ( ≥ 65 Jahre) mit mCRPC, die zuvor mit einer Docetaxel-haltigen Therapie behandelt wurden.
    E.2.2Secondary objectives of the trial
    The following parameters will be evaluated in each arm:
    •Dose reductions and dose delays
    •Radiological progression-free survival (rPFS)
    •Time to PSA progression
    •Time to first symptomatic Skeletal-Related Event (SRE) and incidence of SREs
    •Time to opioid treatment (if relevant)
    •Prostate-specific antigen (PSA) response rate
    •Quality of Life (FACT-P)
    •Objective response rate (ORR) in measurable lesions
    (RECIST criteria 1.1 )
    •Overall Survival (OS)
    •Factors influencing survival (duration of response to first androgen deprivation therapy (ADT), serum testosterone, cumulative dose of cabazitaxel, neutrophils/lymphocytes ratio, Gleason score, geriatric assessment G8, grade ≥3 neutropenia).
    •Time to onset of grade ≥3 neutropenia
    •Grade ≥3 neutropenia duration ( from date of onset of grade ≥ 3 until grade ≤ 2)
    •Analysis of grade ≥3 neutropenia and/or neutropenia by cycle
    •Adverse events
    Die folgenden Parameter werden in jedem Arm bewertet:
    • Dosisreduktionen und Dosisverzögerungen
    • Radioi. progressionsfreies Überleben (rPFS)
    • Zeit bis zur PSA-Progression
    • Zeit bis zum ersten symptom. Skeletal-Related Event (SRE) und Häufigkeit von SREs
    • Zeit bis zur Opioidbehandlung (falls relevant)
    • Ansprechrate des Prostataspezifischen Antigens (PSA)
    • Lebensqualität (FACT-P)
    • Objektive Ansprechrate (ORR) in messbaren Läsionen (RECIST-Kriterien 1.1)
    • Gesamtüberleben (OS)
    • Faktoren, die das Überleben beeinflussen (Dauer der Reaktion auf die erste Androgendeprivationstherapie (ADT), Serumtestosteron, kumulative Dosis von Cabazitaxel, Verhältnis von Neutrophilen zu Lymphozyten, Gleason-Score, geriat. Beurteilung G8, Grad ≥3 Neutropenie).
    • Zeit bis zum Auftreten einer Neutropenie Grad ≥3
    • Grad ≥3 Neutropenie-Dauer (ab dem Zeitpunkt des Beginns der Grad ≥ 3 bis Grad ≤ 2)
    • Analyse von Grad ≥3 Neutropenie und / oder Neutropenie nach Zyklus
    •Unerwünschte Ereignisse
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patient aged ≥ 65 years with mCRPC previously treated with docetaxel
    2.Medical or surgical castration with castrate level of testosterone (< 50 ng/dl)based on the EAU definition of castrate level of testosterone
    3.Progressive disease according to PCWG2
    4.Histologically proven prostate carcinoma
    5.Health status allowing use of chemotherapy: G8 > 14; or G8 score ≤ 14 with geriatric assessment concluding to reversible impairment allowing use of chemotherapy
    6.ECOG-PS 0, 1 or 2(ECOG-PS= 2 should be related to prostate cancer)
    7.Adequate hematologic, liver and renal functions:
    a)Neutrophil count ≥1.5 109/L
    b)Haemoglobin ≥10 g/ dL
    c)Platelet count ≥100.109/L
    d)Total bilirubin ≤ 1 the upper limit of normal (ULN)
    e)Transaminases ≤ 1.5 ULN
    f)Serum creatinine ≤ 2.0 ULN
    8.Ongoing LHRH therapy at study entry
    9.Signed informed consent
    1. Patient ≥ 65 Jahre zuvor mit Docetaxel behandeltem mCRPC
    2.Medizinische oder chirurgische Kastration mit Kastrationsspiegel von Testosteron (<50 ng / dl) basierend auf der EAU-Definition des Kastrationsspiegels von Testosteron
    3. Progressive Krankheit nach PCWG2
    4. Histologisch nachgewiesenes Prostatakarzinom
    5. Gesundheitszustand, der die Verwendung einer Chemotherapie erlaubt: G8> 14; oder G8-Score ≤ 14 bei geriatrischer Beurteilung, die zu einer reversiblen Beeinträchtigung führt, die den Einsatz einer Chemotherapie erlaubt
    6. ECOG-PS 0, 1 oder 2 (ECOG-PS = 2 sollte mit Prostatakrebs in Zusammenhang stehen)
    7.Adequate hämatologische, Leber- und Nierenfunktionen:
    a) Neutrophilenzahl ≥ 1,5 109 / L
    b) Hämoglobin ≥ 10 g / dl
    c) Thrombozytenzahl ≥ 100.109 / L
    d) Gesamtbilirubin ≤ 1 die obere Normgrenze (ULN)
    e) Transaminasen ≤ 1,5 ULN
    f) Serumkreatinin ≤ 2,0 ULN
    8. Fortlaufende LHRH-Therapie bei Studienbeginn
    9. Unterzeichnete Einverständniserklärung
    E.4Principal exclusion criteria
    1.History of severe hypersensitivity reaction (≥grade 3) to docetaxel
    2.History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs
    3.Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
    4.Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix E)
    5.ECOG-PS >2 not related to prostate cancer disease
    6.G8 ≤ 14 with geriatric assessment contra-indicating standard cabazitaxel regimen
    7.Concomitant vaccination with yellow fever vaccine
    8.Patient who cannot be regularly followed or cannot answer to quality of life questionnaires because of psychological, social, familial or geographic reasons.
    9.Participation in another clinical trial with any investigational drug within 30 days prior to study enrolment.
    1.Historie einer schweren Überempfindlichkeitsreaktion (≥ Grad 3) gegen Docetaxel
    2. Verlauf einer schweren Überempfindlichkeitsreaktion (≥ Stufe 3) auf Polysorbat 80-haltige Arzneimittel
    3. Unkontrollierte schwere Krankheit oder medizinischer Zustand (einschließlich unkontrolliertem Diabetes mellitus)
    4.kontinuierliche oder geplante Behandlung mit starken Inhibitoren oder starken Induktoren von Cytochrom P450 3A4 / 5 (eine einwöchige Auswaschphase ist für Patienten erforderlich, die bereits diese Behandlungen erhalten) (siehe Anhang E)
    5.ECOG-PS> 2 nicht im Zusammenhang mit Prostatakrebs-Krankheit
    6. G8 ≤ 14 bei geriatrischer Beurteilung, die kontraindiziert für Standard-Cabazitaxel-Therapie ist
    7. Impfung mit Gelbfieber-Impfstoff
    8. Patienten, die aus psychologischen, sozialen, familiären oder geographischen Gründen nicht regelmäßig auf Fragebögen zur Lebensqualität untersucht werden können.
    9. Teilnahme an einer anderen klinischen Studie mit einem Prüfpräparat innerhalb von 30 Tagen vor Studienbeginn.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is:
    •grade ≥3 neutropenia (measured at D7 and D14 of each cycle) and/or neutropenic complications (febrile neutropenia, neutropenic infection or sepsis) during the overall treatment period
    Der primäre Endpunkt ist:
    • ≥3 Neutropenie (gemessen an D7 und D14 jedes Zyklus) und / oder neutropenische Komplikationen (febrile Neutropenie, neutropenische Infektion oder Sepsis) während der gesamten Behandlungsperiode
    E.5.1.1Timepoint(s) of evaluation of this end point
    Neutropenia will be measured at D7 and D14 of each cycle
    Die Neutropenie wird bei D7 und D14 jedes Zyklus gemessen
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    •Dose reductions and dose delays
    •Radiological progression-free survival (rPFS)
    •PSA response and time to PSA progression
    •Time to first symptomatic Skeletal-Related Event (SRE) and incidence of SREs
    •Time to opioid treatment (if relevant)
    •Quality of life (FACT-P)
    •Objective response rate (ORR) in measurable lesions (RECIST)
    •Overall Survival (OS)
    •Factors influencing survival (duration of response to first ADT, serum testosterone, cumulative dose of cabazitaxel, neutrophils/lymphocytes ratio, Gleason score, G8, grade ≥3 neutropenia)
    •Time to onset of grade ≥3 of neutropenia
    •Grade ≥3 neutropenia duration ( from date of onset of grade ≥ 3 until grade ≤ 2) Analysis of grade ≥3 neutropenia and/or neutropenia by cycle
    •Adverse events
    Die sekundären Endpunkte sind:
    • Dosisreduktionen und Dosisverzögerungen
    • Radiologisches progressionsfreies Überleben (rPFS)
    • PSA-Reaktion und Zeit bis zur PSA-Progression
    • Zeit bis zum ersten symptomatischen Skeletal-Related Event (SRE) und Häufigkeit von SREs
    • Zeit bis zur Opioidbehandlung (falls relevant)
    • Lebensqualität (FACT-P)
    • Objektive Ansprechrate (ORR) in messbaren Läsionen (RECIST)
    • Gesamtüberleben (OS)
    • Faktoren, die das Überleben beeinflussen (Dauer der Reaktion auf die erste ADT, Serumtestosteron, kumulative Dosis von Cabazitaxel, Verhältnis von Neutrophilen zu Lymphozyten, Gleason-Score, G8, Grad ≥3 Neutropenie)
    • Zeit bis zum Einsetzen der Neutropenie ≥3
    • Grad ≥3 Neutropeniedauer (ab dem Zeitpunkt des Beginns der Grad ≥ 3 bis Grad ≤ 2) Analyse von Grad ≥3 Neutropenie und / oder Neutropenie nach Zyklus
    •Unerwünschte Eeignisse
    E.5.2.1Timepoint(s) of evaluation of this end point
    For the 2 arms (A and B):
    -tumor evaluation (CT-Scan abdominal/pelvic/chest or whole body MRI and Bone scan): every 3 months
    -PSA, FACT-P, pain status (VAS), SRE: at each visit
    -hematology: every week
    Für die 2 Arme (A und B):
    - Tumorbeurteilung (CT-Scan Bauch / Becken / Brust oder Ganzkörper-MRT und Knochenszintigraphie): alle 3 Monate
    -PSA, FACT-P, Schmerzstatus (VAS), SRE: bei jedem Besuch
    -Hämatologie: jede Woche
    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 No
    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 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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    The study will end after the last patient included completed all the evaluation required
    Die Studie wird beendet, nachdem der letzte Patient alle erforderlichen Untersuchungen abgeschlossen hat
    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 months42
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months42
    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.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 170
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 170
    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)
    None
    Nein
    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 Decision2019-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-04-06
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