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    Summary
    EudraCT Number:2012-004412-55
    Sponsor's Protocol Code Number:C.HO.SE.
    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:2013-09-10
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-004412-55
    A.3Full title of the trial
    Cabazitaxel in relapsed high-risk HOrmone-SEnsitive
    prostate cancer patients. A multicentric Randomized phase II study.
    C.HO.SE. Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cabazitaxel in relapsed high-risk HOrmone-SEnsitive
    prostate cancer patients. A multicentric Randomized phase II study.
    C.HO.SE. Trial
    A.3.2Name or abbreviated title of the trial where available
    C.HO.SE.
    A.4.1Sponsor's protocol code numberC.HO.SE.
    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 SponsorAZIENDA PROVINCIALE PER I SERVIZI SANITARI DELLA PROVINCIA AUTONOMA DI TRENTO
    B.1.3.4CountryItaly
    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.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAZIENDA PROVINCIALE PER I SERVIZI SANITARI DELLA PROVINCIA AUTONOMA DI TRENTO
    B.5.2Functional name of contact pointMEDICAL ONCOLOGY, S.CHIARA HOSPITAL
    B.5.3 Address:
    B.5.3.1Street AddressLARGO MEDAGLIE D'ORO
    B.5.3.2Town/ citytrento
    B.5.3.3Post code38122
    B.5.3.4CountryItaly
    B.5.4Telephone number00390461902121
    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 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.3.1Product nameCABAZITAXEL
    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.3.11 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
    Relapsed high-risk hormone-sensitive
    prostate cancer
    E.1.1.1Medical condition in easily understood language
    Relapsed high-risk hormone-sensitive
    prostate cancer
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    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 demonstrate the superiority of cabazitaxel plus prednisone at 25
    mg/m² (Arm A) plus ADT versus ADT plus prednisone (Arm B) in term of
    progression-free survival
    (PFS) in hormone-sensitive prostate cancer patients who fail to achieve
    PSA nadir value after 6 months of LHRH-A therapy for rising PSA after
    curative therapy.
    E.2.2Secondary objectives of the trial
    To compare the two study arms for:
    · biochemical PFS
    · time to castration-resistance development
    · metastasis-free survival
    · overall survival
    · tolerability
    · impact on the quality of life
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients meeting all of the following criteria will be considered for
    enrollment into the
    study:
    1. Pathologically confirmed adenocarcinoma of the prostate
    2. Absence of distant metastasis at the diagnosis
    3. Adequate radical treatment for prostate cancer: the following
    treatments are
    allowed for management of initial disease
    · Radical prostatectomy
    · External radical radiotherapy
    · Interstitial brachytherapy
    4. Biochemical failure after primary treatment with curative intent (as
    per EAU
    2011 guideline definitions):
    XML File Identifier: pgnqMWgEieDXnccenPA31nFWt5A=
    Page 15/25
    · After RP: PSA level > 0.2 ng/ml with a second confirmation
    · After EBRT: PSA level > 2 ng/ml above the nadir
    · After IB: : PSA level > 2 ng/ml above the nadir
    5. ADT for biochemical failure (all LHRH-A formulations and dosages are
    allowed) according to the daily clinical practice
    6. Failure to achieve PSA nadir value after 6 months with ADT: patients
    who
    receiving ADT are followed every two months and are evaluated after 6
    months of treatment comparing the PSA value to the value which was
    achieved at the nadir after radical treatment and before biochemical
    progression. The patients could be classified according to three different
    conditions:
    · Good responders to ADT (6-month PSA is equal or less than PSA
    nadir value)
    · Partially responders to ADT (6-month PSA is lower than value before
    ADT start but is greater than PSA nadir value)
    · Non responders to ADT (6-month PSA is greater than PSA nadir value
    or is increasing after a transient response)
    For the purposes of the present study are eligible only the patients
    partially
    responders
    7. ECOG Performance Status 0 or 1
    8. Laboratory requirements at entry
    EudraCT No.
    C.HO.SE. Protocol, Version 1.1, July 2012
    28
    · Absolute neutrophils ≥ 1.5 x 109/L
    · Platelets ≥ 100 x 109/L, Hemoglobin ≥ 9 g/dl
    · Serum creatinine <1.5 x ULN (If creatinine 1.0 - 1.5 x ULN, creatinine
    clearance calculated according to CKD-EPI formula should be ≥60
    mL/min)
    · Serum bilirubin < 1 x UNL ASAT and ALAT < 2.5 UNL
    9. Ability to fill the quality of life questionnaire
    10. Obtained signed informed consent prior to start protocol specific
    requirements
    11. Patient compliance and geographic proximity that allow adequate
    follow-up.
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the
    study:
    1. Age > 75 years
    2. Prior systemic chemotherapy
    3. Prior complete androgen blockage
    4. Prior ADT for the biochemical failure lasting more than 6 months
    5. History of prior malignancies, except for cured non melanoma skin
    cancer or
    other cancer curatively treated and with no evidence of disease for at
    least
    five years
    6. Significant neurological or psychiatric disorders such as dementia that
    would
    prohibit them to understanding or rendering informed consent or from
    fully
    complying with treatment and follow-up
    7. Other serious concomitant illness of medical conditions
    8. Any other condition which in the judgment of the investigator would
    place the
    subject at undue risk or interfere with the study.
    E.5 End points
    E.5.1Primary end point(s)
    Kaplan-Meier estimates of progression-free survival
    E.5.1.1Timepoint(s) of evaluation of this end point
    ARM A. The on-study evaluations must be performed on day 1 of each
    cabazitaxel course (or at least within 2 days before). The final evaluation
    must be performed within 4 weeks after the last drug
    administration.
    ARM B.The "on-study" evaluations will be performed within 1 week after
    randomization and
    at the 10th week after randomization.The final evaluation must be
    performed between the 19th and the 22nd week after
    randomization.Patients who are progression-free at the end of the "on
    study" period must be
    evaluated every 2 months until progression.
    E.5.2Secondary end point(s)
    Kaplan-Meier estimates of biochemical progression-free survival
    · Kaplan-Meier estimates of time to distant metastasis appearance
    · Kaplan-Meier estimates of time to castration resistance development
    · Kaplan-Meier estimates of overall survival
    · type and grade of any adverse reaction to treatment with cabazitaxel,
    according to CTC-AE v. 4.03
    · functional scales and items of EORTC QLQ-C30 v.3.0 questionnaire
    E.5.2.1Timepoint(s) of evaluation of this end point
    ARM A. The on-study evaluations must be performed on day 1 of each
    cabazitaxel course (or at least within 2 days before). The final evaluation
    must be performed within 4 weeks after the last drug
    administration.
    ARM B.The "on-study" evaluations will be performed within 1 week after
    randomization and
    at the 10th week after randomization.The final evaluation must be
    performed between the 19th and the 22nd week after
    randomization.Patients who are progression-free at the end of the "on
    study" period must be
    evaluated every 2 months until 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 No
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 concerned9
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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) Yes
    F.1.2.1Number of subjects for this age range: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 state140
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 140
    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
    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 Decision2013-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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