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    Summary
    EudraCT Number:2011-004831-30
    Sponsor's Protocol Code Number:UC-0101/1104
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-09-17
    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 ConcernedFrance - ANSM
    A.2EudraCT number2011-004831-30
    A.3Full title of the trial
    Safety and efficacy of radiotherapy combined with a 6-month LH-RH agonist and abiraterone hormone therapy treatment in biochemically-relapsing prostate cancer following surgery.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    A.3.2Name or abbreviated title of the trial where available
    GEP12-CARLHA
    A.4.1Sponsor's protocol code numberUC-0101/1104
    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 SponsorUNICANCER
    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 supportJanssen Cilag
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNICANCER
    B.5.2Functional name of contact pointKarine BUFFARD - Project Manager
    B.5.3 Address:
    B.5.3.1Street Address101 rue de Tolbiac
    B.5.3.2Town/ cityParis Cedex 13
    B.5.3.3Post code75654
    B.5.3.4CountryFrance
    B.5.4Telephone number33144 23 55 77
    B.5.5Fax number33144 23 55 69
    B.5.6E-mailk.buffard@unicancer.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 Zytiga
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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.3.4Pharmaceutical form 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.3.9.1CAS number 154229-18-2
    D.3.9.3Other descriptive nameABIRATERONE ACETATE
    D.3.9.4EV Substance CodeSUB31647
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    Biochemically-relapsing prostate adenocarcinoma following radical prostatectomy.
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    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 LLT
    E.1.2Classification code 10001186
    E.1.2Term Adenocarcinoma of prostate
    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
    Phase I: To determine the maximum tolerated dose (MTD) and the phase II recommended dose (P2RD) of abiraterone acetate plus prednisone combined with radiotherapy and LH-RH agonist treatment in patients with biochemical relapse from prostate cancer following surgery.

    Phase II: To determine the 3-year Biochemical Relapse-free survival
    E.2.2Secondary objectives of the trial
    Phase I and II:
    • To determine the overall safety (3 years) profile
    • To define the 3-year Overall survival
    • To define the 3-year Metastases-free survival
    • Time to achieve PSA nadir

    Ancillary research
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Ancillary research
    Phase I:
    • To assess testosterone and LH serum level variations during one month after abiraterone initiation
    • To explore circulating tumor cells

    Phase II :
    • To assess testosterone and LH serum level variations during one month after abiraterone initiation
    • To explore circulating tumor cells
    • To explore castration-induced osteopenia
    • To assess the quality of life before, during and after study treatment (QLQ C30 PR25, IIEF)
    E.3Principal inclusion criteria
    1. Histologically confirmed prostate adenocarcinoma

    2. The patients should have undergone only surgery for localized prostate adenocarcinoma: pT2, pT3 or pT4 with bladder neck involvement

    3. pN0: negative lymphadenectomy at the time of prostatectomy

    4. At inclusion the patients should have no clinical signs of progressive disease and should be M0 (bone and pelvic scans).

    5. ≥ 18 years of age with life expectancy ≥ 10 years

    6. Performance Status (ECOG) ≤ 1

    7. PSA ≤ 0.1 ng/ml after prostatectomy (dosage performed within 2 months after surgery)

    8. PSA ≥ 0.2 ng/ml et ≤ 2 ng/ml at the time of inclusion

    9. Elevation of PSA over three consecutive assays performed in the same laboratory, with a minimal interval of two months between assays, (PSA nadir level followed by two other progressive assays)

    10. At least 6 months between surgery and biochemical relapse

    11. Serum potassium ≥ 3.5 mmol/L in the 72 hours before first dose of abiraterone acetate

    12. Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min

    13. Liver function:
    - Serum bilirubin < 1.5 x ULN (except for patients with documented Gilbert’s disease)
    - AST and ALT < 2.5 x ULN

    14. Patients must be affiliated to a Social Security System.

    15. Patient information and written informed consent form signed for both principal and additional research

    16. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
    E.4Principal exclusion criteria
    1. pN1: histologically-proven lymph node involvement at initial lymphadenectomy

    2. Histology other than adenocarcinoma

    3. Previous hormone therapy including prior therapy with ketoconazole or other CYP17 inhibitor(s) for prostate cancer.

    4. Patients being treated within the last 14 days prior to inclusion with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A4 (Clarithromycin, Ketoconazole, Itraconazole, Voriconazole, Ritanovir, see appendix 11) or requiring those treatments during the study

    5. Active or symptomatic viral hepatitis or chronic liver disease

    6. Surgical or chemical castration

    7. History of cancer, with the exception of basal cell carcinoma or any other cancer treated in the 5 years before inclusion and in complete remission.

    8. Previous pelvic radiotherapy

    9. Uncontrolled hypertension (defined as systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy (see appendix 10 for mandatory BP measurement guidelines)

    10. Severe and moderate hepatic impairment (Child-Pugh class B and C)

    11. Patients with severe and/or uncontrolled medical disease which could compromise participation in the study, such as, but not limited to:
    Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline

    12. Known hypersensitivity to any of the study drugs or excipients.

    13. Galactosemia, Glucose-galactose malabsorption or lactase deficiency

    14. Patients with any psychological, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

    15. Individual deprived of liberty or placed under the authority of a tutor.

    16. Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within a period of 30 days.
    E.5 End points
    E.5.1Primary end point(s)
    hase I part:
    The main objective is to determine the maximum tolerated dose (MTD) and the phase II
    recommended dose. Determination of the MTD is based on the occurrence of DLT (Dose Limiting
    toxicity)
    The DLT evaluation period lasts 11 weeks starting from the radiotherapy initiation.
    Toxicities are assessed weekly during the DLT evaluation period and at every visit through a
    clinical assessment, laboratory examinations and an ECG every 3 months. Toxicities are scored
    according National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
    (CTCAE), version 4.0.

    Phase II part:
    The safety analysis for the phase II part will include those patients who received at least one
    dose of abiraterone and those treated in phase I treated at the dose carried forward in the phase
    II.
    Toxicities are assessed at every visit through a clinical assessment, laboratory examinations and
    an ECG every 3 months. Toxicities are scored according National Cancer Institute (NCI)
    Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.

    EFFICACY ASSESSMENT:
    Phase II primary endpoint:
    To determine the 3-year biochemical relapse-free survival.
    Biochemical relapse will be retrospectively defined by the date of the first PSA elevation
    following the 6-month abiraterone treatment (PSA ≥ 0.5 ng/ml and 2 consecutive PSA increases
    over a 2-month interval).
    When PSA ≥ 0.5 ng/ml, 2 consecutive dosages have to be done over a 2-month interval to
    confirm biochemical relapse. If no biochemical relapse is observed, the 6-month assessment is
    then resumed.
    PSA assays must always be performed for each patient in the same laboratory.
    3-year RFS is calculated from the date of inclusion until the date of first evidence of a
    documented biological progression and analyzed using Kaplan-Meier method.

    Secondary endpoints:
    3 year overall survival (OS).
    3-year metastases-free survival.
    The time to achieve PSA.
    E.5.2Secondary end point(s)
    EXPLORATORY ASSESSMENT:
    Phase I and II:
    Testosterone and LH serum levels (all testosterone and LH assays must be done for each patient
    in the same laboratory)
    Number of circulating tumor cells (CTC).
    Phase II:
    Bone density.
    Quality of life is assessed using the QLQ-C30, PR25 and IIEF questionnaires
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Phase I:
    • To assess testosterone and LH serum level variations during one month after abiraterone
    initiation
    • To explore circulating tumor cells

    Phase II :
    • To assess testosterone and LH serum level variations during one month after abiraterone
    initiation
    • To explore circulating tumor cells
    • To explore castration-induced osteopenia
    • To assess the quality of life before, during and after study treatment (QLQ C30 PR25, IIEF)
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    determine the maximum tolerated dose
    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 No
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    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) 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 state43
    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 Decision2012-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-06
    P. End of Trial
    P.End of Trial StatusOngoing
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