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    Summary
    EudraCT Number:2017-000560-15
    Sponsor's Protocol Code Number:P161201J
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-01-12
    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 number2017-000560-15
    A.3Full title of the trial
    Intra-individual dose escalation of abiraterone acetate according to its plasma concentration in patients with progressive castration-resistant metastatic prostate cancer
    Escalade de dose intra-individuelle de l'acétate d'abiratérone en fonction de sa concentration plasmatique chez des patients présentant un cancer de prostate métastatique résistant à la castration et en progression tumorale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intra-individual dose escalation of abiraterone acetate according to its concentration in blood in patients with progressive castration-resistant metastatic prostate cancer
    Evaluation de l'augmentation de la dose d'acétate d'abiratérone, en cas de concentration dans le sang trop faible, pour bloquer l'évolution du cancer chez des patients présentant un cancer de prostate métastatique résistant à la castration et en progression tumorale
    A.3.2Name or abbreviated title of the trial where available
    OPTIMABI
    A.4.1Sponsor's protocol code numberP161201J
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailjosephine.braun@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 Abiraterone acetate (Zytiga®)
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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.3.1Product nameAbiraterone acetate (Zytiga®)
    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.3.8INN - Proposed INNacétate d'abiratérone
    D.3.9.3Other descriptive nameabiraterone acetate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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 carcinoma men, aged >/= 18 years
    E.1.1.1Medical condition in easily understood language
    Metastatic castration-resistant prostate cancer
    Cancer de la prostate présentant des localisations secondaires (métastases) et maladie évoluant malgré une privation hormonale appelée castration
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    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
    Non-progression rate at 12 weeks in patients receiving ABI at a dose of 2000 mg / day after failure of standard dose (1000 mg/day).
    E.2.2Secondary objectives of the trial
    Step 1:
    - Incidence of underexposure to ABI during the first three months in patients treated at standard dose (1000 mg/day) and identification of inter- and intra-individual variability factors of plasma levels of ABI.
    - Evaluation of medical adherence and correlation with mean ABI concentration and socioeconomic conditions.
    - Progression free survival (time from the day of inclusion to disease progression or death) and correlation with underexposure to ABI.
    Step 2:
    - PSA response rate.
    - Progression free survival.
    - Safety of ABI at a dose of 2000 mg/day.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Step 1
    - Male 18 years and older.
    - Voluntary signed informed consents of the patient
    - Histologically confirmed prostate adenocarcinoma.
    - Presence of bone and/or soft-tissue and/or visceral metastases through CT scan, MRI, or scintigraphy scan.
    - Progressive disease assessed by PSA, CT scan, MRI or bone scan according to the PCGW3 criteria
    - Patient with no or moderate symptoms (no need for continuous opioid treatment)
    - Effective castration confirmed by testosterone plasma level < 50 ng/mL
    - ECOG performance status: 0-2
    - Life expectancy > 3 months
    - Patient affiliate to french social secutity
    - Laboratory criteria:
    SGPT and SGOT < 5 fold the upper normal value
    Kaliemia > 3 mM
    Step 2
    - Patients receiving ABI 1000 mg/day through step 1 for at least two months
    - At least two measures of ABI plasma concentrations available within the first three months of treatment
    - Mean of ABI concentration < 8,5ng/mL.
    - Progressive disease according to PCWG3 criteria within 28 weeks following starting of ABI in the step 1 (according to PCWG3 criteria of progression at trial entry, isolated PSA increase will be accepted).
    - Inclusion in step 2 must occur within 2 months following the first observation of cancer progression while in step 1.
    E.4Principal exclusion criteria
    Step 1
    - Pure small cell carcinoma of the prostate or predominant histology of neuro-endocrine carcinoma
    - Confirmed brain and/or leptomeningeal metastases
    - Previous treatment with docetaxel or any other anticancer treatment for castration-resistant prostate carcinoma (previous docetaxel for hormone-sensitive metastatic disease is allowed)
    - Previous treatment with ABI or any other 17 B hydroxylase inhibitor or Enzalutamide
    -Treatment with first-generation antiandrogen performed on the day of screening or within previous four weeks.
    - Patient co-morbidities:
    Galactose hypersensitivity, Lapp lactase deficiency.
    Cirrhosis Child-Pugh B or C
    Active or symptomatic viral hepatitis
    Heart failure stage NYHA III or IV
    Cardiac arythmia, heart failure stage NYHA II, ischemic cardiopathy or uncontroled hypertension, except if left ventricular ejection fraction is > 50%
    Patients with left ventricular ejection fraction (LVEF) < 50%
    Severe hypokaliema

    Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications.
    Prior or concurrent malignant disease in complete remission for less than 3 years, except T1N0 vocal cord carcinoma, basal or squamous cell skin carcinoma and in situ transitional cell bladder carcinoma
    - Limitation of the patient's ability to comply with the treatment or to follow the protocol.
    Step 2
    - Persistent grade 3-4 toxicities related to ABI. In case of persistent grade 2 toxicity or resolutive grade 3-4 toxicities, inclusion in step 2 must be discussed in a case by case basis with the study coordinating Investigator.
    - All non-inclusion criteria for step 1 apply
    - Patient who does not take ABI daily at the investigator opinion
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of patients who do not experience progressive disease at 12 weeks from the day of inclusion in step 2.
    At 12 weeks, disease progression will be defined by PSA and/or radiographic progression.

    Secondary endpoints are :
    - Underexposure to ABI
    - Measure of medical adherence
    - PSA response rate
    - Progression-free survival
    - Safety of dose escalation
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 semaines
    E.5.2Secondary end point(s)
    Underexposure to ABI
    Measure of medical adherence
    PSA response rate
    Progression-free survival
    Safety of dose escalation
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 semaines
    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 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 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 Yes
    E.8.1.7.1Other trial design description
    non-comparatif
    non-comparative phase 2 study
    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.8.2.4Number of treatment arms in the trial1
    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
    LVLS
    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 days0
    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) No
    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 state175
    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)
    For patients without progressive disease, the study will be concluded and no further investigation is mandatory. The treatment will be continued at the investigator discression.
    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 Decision2017-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-07
    P. End of Trial
    P.End of Trial StatusCompleted
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