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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-001606-14
    Sponsor's Protocol Code Number:2017/2555
    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:2017-10-20
    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 number2017-001606-14
    A.3Full title of the trial
    A study of patient preference between ODM-201 and Enzalutamide in men with metastatic castrate-resistant prostate cancer
    Etude de préférence des patients entre l’ODM-201 et l’Enzalutamide chez des hommes atteints d’un cancer de la prostate métastatique résistant à la castration
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of patient preference between ODM-201 and Enzalutamide in men with metastatic castrate-resistant prostate cancer
    Etude de préférence des patients entre l’ODM-201 et l’Enzalutamide chez des hommes atteints d’un cancer de la prostate métastatique résistant à la castration
    A.3.2Name or abbreviated title of the trial where available
    ODENZA Preference
    A.4.1Sponsor's protocol code number2017/2555
    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 SponsorGustave Roussy
    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 supportBAYER
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGustave Roussy
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street Address114, rue Edouard Vaillant
    B.5.3.2Town/ cityVillejuif
    B.5.3.3Post code94805
    B.5.3.4CountryFrance
    B.5.4Telephone number33142115607
    B.5.5Fax number33142116290
    B.5.6E-mailgeraldine.martineau@gustaveroussy.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 No
    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 nameODM-201
    D.3.2Product code BAY1841788
    D.3.4Pharmaceutical form Film-coated 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 INNDAROLUTAMIDE
    D.3.9.1CAS number 1297538-32-9
    D.3.9.2Current sponsor codeODM-201 (BAY1841788)
    D.3.9.4EV Substance CodeSUB71144
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    Cancer de la prostate résistant à la castration
    E.1.1.1Medical condition in easily understood language
    Metastatic Castration resistant 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 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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076506
    E.1.2Term Castration-resistant 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
    To assess patient preference between ODM-201 and enzalutamide by patient preference questionnaire
    Evaluer la préférence des patients entre l’ODM-201 et l’enzalutamide par un questionnaire de préférence patient
    E.2.2Secondary objectives of the trial
    1. To evaluate reasons for patient preference as assessed by patient preference questionnaire
    2. To evaluate dose modifications and time to dose modification
    3. To evaluate tolerance of each drug
    4. To evaluate fatigue as assessed by the Brief Fatigue Inventory (BFI) after treatment period 1 and 2
    5. To evaluate cognitive function as assessed by Cogstate computerized cognitive tests after treatment period 1 and 2
    6. To perform a depression screening test as assessed by the CES-D test after treatment period 1 and 2
    7. To evaluate the incidence of falls (recorded in a patient diary)
    8. To evaluate PSA decline (Waterfall plots) after each treatment period, per drug
    9. To assess progression-free survival (PFS)
    10. To assess the association between PSA at 4 weeks and PFS
    11. To evaluate the incidence of cancer progression or death after period 1 and 2, per randomization arm
    12. To assess tumor response in patients with nodal or visceral metastases using RECIST 1.1 criteria
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    To identify molecular mechanisms of resistance to AR-targeted therapies (enzalutamide and ODM-201) in patients with metastatic castration-resistant prostate cancer (CRPC) treated in this study.
    E.3Principal inclusion criteria
    1. Male patients older than 18 years
    2. Histologically confirmed adenocarcinoma of the prostate
    3. Evidence of metastatic disease (imaging can include bon scan, CT scan, PET choline, PET PSMA and MRI)
    4. Continued androgen deprivation therapy (ADT) either with LHRH agonists/antagonists or bilateral orchiectomy
    5. Serum testosterone <0.50 ng/ml (1.7 nmol/L)
    6. Progressive disease (PSA progression or radiological progression or clinical progression) as per PCWG3 criteria
    7. ECOG 0-1 (2 is accepted if the impairement is not due to prostate cancer)
    8. Asymptomatic or mildly symptomatic (Brief Pain Inventory<4) prostate cancer
    9. Information imparted to the patient and the informed consent form signed by the patient or his legal representative
    10. Ability to comply with the protocol procedures
    11. Patient affiliated to a social security system or beneficiary of the same
    12. Sexually active male subjects unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation, and/or their female partners of reproductive potential to use a method of effective birth control, during the study treatment and for 3 months after the end of the treatment
    13. adequate organ or bone marrow function as evidenced by:
    o Hemoglobin ≥ 9 g/dL
    o Absolute neutrophil count ≥ 1.5 x 109/L,
    o Platelet count ≥ 100 x 109/L,
    (subject must not have received any growth factor within 4 weeks or blood transfusion within 7 days of the hematology laboratory sample obtained at screening)
    o AST/SGOT and/or ALT/SGPT ≤1.5 x ULN;
    o Total bilirubin ≤ 1.5 x ULN, (except subjects with a diagnosis of Gilbert’s disease),
    o Serum creatinine ≤ 2 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to the CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded.
    E.4Principal exclusion criteria
    1. Prior treatment with abiraterone, enzalutamide, ODM-201, ARN-509 or any other next-generation AR axis-targeting drug
    2. Prior treatment with a taxane for CRPC (prior treatment with a taxane for castration-sensitive or castration-naïve prostate cancer is allowed)
    3. Prior treatment with radium-223
    4. Patients receiving an investigational drug within 4 weeks prior to enrolment (approved drugs with a long history of use such as aspirin, statins, heparins, or metformin, even used in an experimental setting are accepted)
    5. Treatment with radiotherapy (external beam radiation therapy [EBRT], brachytherapy, or radiopharmaceuticals) within 2 weeks before randomization
    6. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
    7. Acute toxicities of prior treatments and procedures not resolved to grade <=1 or baseline before randomisation.
    8. Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association (NYHA) Class III or IV)
    9. Uncontrolled hypertension as indicated by a resting systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg despite optimal medical management
    10. Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed ≥5 years before randomization and from which the subject has been disease-free
    11. A gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study treatment
    12. An active viral hepatitis, active human immunodeficiency infection (HIV), or chronic liver disease with a need for treatment.
    13. Any other serious or unstable illness or infection, or medical, social, or psychological condition, that could jeopardize the safety of the subject and/or his compliance with study procedures, or may interfere with the subject’s participation in the study or evaluation of the study results
    14. Inability to swallow oral medications
    E.5 End points
    E.5.1Primary end point(s)
    Patient preference between ODM-201 and enzalutamide assessed by a single question (patient preference questionnaire), in the modified intent-to-treat population as defined by all patients who received at least one dose of drug from each treatment period and who did not have documented progressive disease at the end of the treatment period 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After completion of the second period of treatment
    E.5.2Secondary end point(s)
    *Reasons for patient preference as assessed by patient preference questionnaire
    *Dose modifications and time to dose modification
    *Safety as assessed by grading adverse events with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03) until up to 28 days (+7) days after the last dose of study treatment
    *Fatigue as assessed by the Brief Fatigue Inventory (BFI) after each treatment period
    *Cognitive function as assessed by Cogstate computerized cognitive tests after treatment period 1 and treatment period 2
    *Depression screening as assessed by the Center for Epidemiological Studies-Depression (CES-D) test after each treatment period
    *Frequency of falls (recorded in a patient diary)
    *PSA declines using Waterfall plots after each treatment period, per drug
    *Progression-Free Survival (PFS)
    *Association between 4-weeks PSA value and PFS
    *Incidence of cancer progression or death after period 1 and 2, per randomization arm
    *Tumor response in patients with nodal or visceral metastases using RECIST 1.1 criteria

    Ancillary study outcomes
    *Type and Frequency of molecular alterations in primary resistant tumors vs responsive tumors
    *Comparison of the molecular profile in patients upon relapse with the molecular obtained profile prior to treatment with AR targeted therapies;
    *Comparison of mechanisms of resistance between ODM-201 and Enzalutamide
    *Identification of mutational processes driving resistance to AR-targeted therapies
    E.5.2.1Timepoint(s) of evaluation of this end point
    see E.5.2
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.6Cross over Yes
    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 concerned30
    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
    The end of the study is defined as the Last Patient Last Visit. LPLV is defnied as the date of the last protocol-specified visit/assessment for the last subject in the study.
    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 months50
    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.1.2.1Number of subjects for this age range: 80
    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 state250
    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 Decision2017-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-22
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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