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    Summary
    EudraCT Number:2018-002249-13
    Sponsor's Protocol Code Number:3125001
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-02-11
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2018-002249-13
    A.3Full title of the trial
    SAFETY AND PHARMACOKINETICS OF ODM-209 IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER OR ESTROGEN RECEPTOR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE ADVANCED BREAST CANCER
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SAFETY AND PHARMACOKINETICS OF ODM-209 IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER OR ESTROGEN RECEPTOR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE ADVANCED BREAST CANCER
    A.3.2Name or abbreviated title of the trial where available
    STESIDES
    A.4.1Sponsor's protocol code number3125001
    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 SponsorOrion Corporation Orion Pharma
    B.1.3.4CountryFinland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOrion Corporation Orion Pharma
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOrion Corporation Orion Pharma
    B.5.2Functional name of contact pointJutta Hänninen
    B.5.3 Address:
    B.5.3.1Street AddressOrionintie 1
    B.5.3.2Town/ cityEspoo
    B.5.3.3Post codeFI 02200
    B.5.3.4CountryFinland
    B.5.4Telephone number+35810426 7792
    B.5.6E-mailclinicaltrials@orionpharma.com
    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-209
    D.3.2Product code ODM-209
    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 INNODM-209
    D.3.9.3Other descriptive nameODM-209
    D.3.9.4EV Substance CodeSUB194015
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 2
    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-209
    D.3.2Product code ODM-209
    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 INNODM-209
    D.3.9.3Other descriptive nameODM-209
    D.3.9.4EV Substance CodeSUB194015
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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.IMP: 3
    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-209
    D.3.2Product code ODM-209
    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 INNODM-209
    D.3.9.3Other descriptive nameODM-209
    D.3.9.4EV Substance CodeSUB194015
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.IMP: 4
    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-209
    D.3.2Product code ODM-209
    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 INNODM-209
    D.3.9.3Other descriptive nameODM-209
    D.3.9.4EV Substance CodeSUB194015
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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.IMP: 5
    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-209
    D.3.2Product code ODM-209
    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 INNODM-209
    D.3.9.3Other descriptive nameODM-209
    D.3.9.4EV Substance CodeSUB194015
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 OR ESTROGEN RECEPTOR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE ADVANCED BREAST CANCER
    E.1.1.1Medical condition in easily understood language
    METASTATIC CASTRATION-RESISTANT PROSTATE CANCER OR ADVANCED BREAST CANCER
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10076506
    E.1.2Term Castration-resistant prostate cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10072737
    E.1.2Term Advanced breast cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1:
    Primary objectives are
    - to evaluate the safety and tolerability of ODM-209;
    - to define the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ODM-209, if feasible;
    - to define the recommended dose of ODM-209 for prostate cancer and breast cancer and replacement therapy for Part 2 of the study.

    Part 2:
    - to further evaluate the safety and tolerability of ODM-209;
    - to evaluate the preliminary anticancer activity of ODM-209.
    E.2.2Secondary objectives of the trial
    Part 1:
    - to characterise the pharmacokinetics (PK) of ODM-209 and its major metabolite ORM-38045 after single and repeated administrations;
    - to evaluate the dosing schedule of ODM-209.
    Part 2:
    - to evaluate the recommended dose of ODM-209 for further clinical studies.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    PC patients
    1Signed written IC obtained
    2Male aged ≥18 years
    3Patients with histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
    4Metastatic disease documented with a biopsy and/or imaging using CTor MRI
    5CRPC with serum testosterone < 50 ng/dl (< 1.7 nmol/l)
    6Have documented disease progression by one or more of the following criteria
    a.PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ≥ 1 week between each assessment with serum PSA at the time of screening ≥ 2 ng/ml b.Soft tissue disease progression as defined by the RECIST 1.1 criteria c.Bone disease progression as defined by the PCWG3 criteria
    7Patients must maintain ongoing androgen deprivation therapy with a gonadotropin releasing hormone analogue (either an agonist or an antagonist) or have had bilateral orchiectomy
    8Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
    9Have had treatment with at least 1 line of chemotherapy for advanced disease or be ineligible for chemotherapy
    10Have had treatment with targeted endocrine therapy (defined as a second-generation antiandrogen therapy with e.g. abiraterone, enzalutamide, apalutamide, darolutamide) for castration-sensitive prostate cancer (CSPC) and/or for CRPC
    11Adequate marrow, liver, and kidney function defined as follows
    •hemoglobin ≥10 g/dl (in absence of blood transfusion within 7 days of value obtained)•absolute neutrophil count (ANC) ≥1500/μl (1.5 x
    109/l)•platelet count ≥100 000/μl (100 x 109/l)•serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 x the upper limit of normal (ULN) (≤5.0 x ULN if liver metastases present)•serum total bilirubin ≤1.5 x ULN (< 3 ULN if Gilbert's syndrome)•serum albumin ≥3.0 g/dl•serum/plasma creatinine ≤1.5 ULN•serum potassium and sodium within the institutional normal reference range limits
    12Resolution of the acute toxic effects from prior cancer therapy or surgical procedures to the NCI CTCAE v4.03 Grade ≤1 (except for alopecia, nail changes, and grade 2 peripheral neuropathy)
    13Able to follow the study instructions, to comply with the replacement therapy dosing and regimen, and other study requirements
    14Able to swallow tablets
    14Able to swallow tablets
    15AR mutation positive cohorts
    BC patients
    1 Signed written IC obtained
    2 Female aged ≥18 years who are either
    •Postmenopausal, as defined by at least one of the following criteria: age ≥ 60 years;age < 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and follicle-stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females documented bilateral oophorectomy
    medically confirmed ovarian failure•Pre/peri-menopausal (i.e not meeting the criteria for being postmenopausal) if amenable to be treated
    with the GnRH agonist or antagonist. Patients must have commenced treatment with GnRH agonist or antagonist at least 4 weeks prior to start of study treatment
    3 Patients with histologically confirmed breast carcinoma4. ER-positive breast cancer (defined as >1% cancer cell nuclei stain positively) based on a biopsy
    5 HER2-negative breast cancer (defined as immunohistochemistry [IHC] status 0 or 1+ or negative in situ hybridization [ISH] test) based on the most recent biopsy. If HER2 IHC is 2+ a negative ISH test is required. HER2 3+ (IHC) do not need ISH confirmation 6. Performance status 0-1 on the ECOG Performance Scale
    7 In Part 1: Either measurable or non-measurable disease by RECIST 1.1, or bone-only metastatic disease confirmed by CT or MRI. In Part 2Measurable disease by the RECIST
    8 Have documented disease progression after treatment with at least 2 lines of systemic treatment for advanced breast cancer. Of these, at least
    one line must have been endocrine treatment
    9 Adequate marrow, liver, and kidney function defined as follows •hemoglobin ≥10 g/dl (in absence of blood transfusion within 7 days of
    value obtained)•absolute neutrophil count (ANC) ≥1500/μl (1.5 x 10⁹ /l)•platelet count ≥100 000/μl (100 x 10⁹/l)•serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 x the upper limit of normal (ULN) (≤5.0 x ULN if liver metastases present) •
    serum total bilirubin ≤1.5 x ULN (< 3 ULN if Gilbert's syndrome)•serum albumin ≥3.0 g/dl•serum/plasma creatinine ≤1.5 ULN•serum potassium and sodium within the institutional normal reference range limits
    10 Resolution of acute side effects from prior cancer therapy or surgical procedures to the NCI CTCAE v4.03 Grade ≤1 (except for alopecia, nail
    changes, and grade 2 peripheral neuropathy)
    11 Able to follow the study instructions, to comply with the replacement therapy dosing and regimen, and other study requirements
    12 Able to swallow tablets
    13 ESR1 mutation–negative cohort(s):absence of somatic mutation in the LBD of ESR1

    E.4Principal exclusion criteria
    Prostate cancer patients
    1. History of pituitary dysfunction
    2. Known brain metastases or active leptomeningeal disease
    3. Concurrent other invasive malignancy; patients who have undergone potentially curative therapy for a prior invasive malignancy are eligible provided there is no evidence of disease for ≥ 5 years after the diagnosis
    4. Active or uncontrolled autoimmune disease requiring concurrent corticosteroid therapy
    5. Active infection or other medical condition that would make corticosteroids contraindicated
    6. Use of aldosterone antagonist or phenytoin within 4 weeks prior to start of study treatment
    7. Patients with an unstable dose of thyroid hormone replacement therapy within 6 months prior to the start of the study treatment
    8. Chemotherapy (or CDK4/6 inhibitor therapy in Breast cancer patients)
    within 3 weeks prior to the start of the study treatment
    9. Radiotherapy within 2 weeks prior to start of the study treatment
    10. Use of enzalutamide within 4 weeks and abiraterone acetate within 2 weeks prior to the start of study treatment. Use of other anticancer therapy (excluding GnRH agonists/antagonists) within 3 weeks prior to the start of the study treatment. Use of immune checkpoint inhibitor within 12 weeks prior to start of the study treatment.
    11. Use of any investigational second-generation antiandrogen therapy (prostate cancer) in phase 2
    12. GI disease that may interfere with absorption of the study treatment
    13. Poorly controlled diabetes or other diseases that may interfere with the study treatment
    14. History of seizure or any condition that may predispose to seizure
    15. Clinically significant cardiovascular disease, e.g. myocardial infarction, arterial thrombotic events, or pulmonary embolism in the past 6 months, unstable angina, or congestive heart failure (NYHA class II-IV)
    16. Recent symptomatic cerebrovascular accident within one month e.g. TIA, stroke or cerebral hemorrhage
    17. Hypotension: supine systolic BP < 110 mmHg, or uncontrolled hypertension: supine systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg, in 2 out of 3 recordings with optimized antihypertensive therapy
    18. History or family history of the long QTc syndrome. Repeatable prolongation of the QTcF interval > 450 ms or any clinically significant abnormality in the ECG
    19. Sexually active subject, who does not agree to use condoms during the study and until 3 months after the last dose of ODM-209 (prostate cancer)
    20. Major surgery within 4 weeks before the start of the study treatment
    21. Severe or uncontrolled concurrent medical condition or psychiatric illness
    22. Known history of HIV infection
    23. Acute or chronic hepatitis B or hepatitis C infection
    24. Use of any investigational drug 4 weeks (immune checkpoint inhibitors 12 weeks) prior to the start of the study treatment
    For breast cancer only:
    10. Administration of endocrine therapy other than GnRH therapy for breast cancer in premenopausal women within 2 weeks (except for fulvestrant within 4 weeks), or ovarian ablation therapy within 8 weeks prior to the start of the study treatment
    22. Subject is pregnant or breast-feeding. Subject with childbearing potential (i.e. menstruating, or less than 12 months from the last menstruation) must have a negative pregnancy test
    23. Subject of childbearing potential who does not agree to use highly effective contraception (e.g. hormonal contraception, intrauterine device [IUD] or surgical sterilization during the study and until 3 months after the last dose of ODM-209
    24. Use of any investigational drug 4 weeks (immune checkpoint inhibitors 12 weeks) prior to the start of the study treatment.
    E.5 End points
    E.5.1Primary end point(s)
    - Safety: (serious) adverse events, vital signs including blood pressure, heart rate, body temperature and orthostatic test, 12-lead ECGs, physical exams, laboratory assessments: hematology, chemistry, urinalysis.
    - Efficacy assessments: Serum total PSA (only PC patients), soft tissue response by CT or MRI scan, bone scan (only PC patients), ECOG performance score, bone mineral density
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Safety: Determined at several time-points (continuously/every visit)
    - Efficacy assessments: Serum total PSA (every 4 weeks for 24 weeks; every 12 weeks thereafter), soft tissue response by CT or MRI scan (every 8 weeks for 24 weeks; every 12 weeks thereafter), bone scan (every 8 weeks for 24 weeks; every 12 weeks thereafter), ECOG performance score at each visit
    E.5.2Secondary end point(s)
    - Pharmacokinetic assessments: Part 1: Multiple blood samples for PK; additional single samples; Part 2 single samples
    - Plasma samples for protein binding;
    Metabolite screening: Multiple blood samples; urine collection
    - Pharmacodynamic assessments: Testosterone level or estradiol and estrone level and other steroid hormones
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Pharmacokinetic assessments: Part 1: Multiple blood samples for PK on study days 1 and 8; additional single samples on days 15 and 29 and week 16; Part 2 single samples on Day 1 and 15 and at week 16
    - Plasma samples for protein binding at 2 time points on Day 8;
    Metabolite screening: Multiple blood samples on study days 1 and 8, and a single sample on Day29; urine collection on study days 1 and 8
    - Pharmacodynamic assessments: Testosterone level or estradiol and estrone level and other steroid hormones: Multiple blood samples on study days 1 and 8. PD patients single samples on day 29, wk 16, wk 24, and every 12 weeks thereafter
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    The end of the study is defined as the date of the last subject's last visit
    or last contact with the study site.
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial 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) Yes
    F.1.2.1Number of subjects for this age range: 192
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 256
    F.4.2.2In the whole clinical trial 256
    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)
    Availability of ODM-209 after termination
    There is no option to continue ODM-209 treatment therapy once the patient has discontinued the study. Subsequent treatments of the patient will be at the discretion of the attending physician.

    Availability of auxiliary medicinal products after termination
    Once the patient has discontinued the study, there is an option to continue hydrocortisone and/or fludrocortisone treatment until the end of adrenal recovery follow-up (maximum up to 24 weeks).
    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 Decision2019-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-18
    P. End of Trial
    P.End of Trial StatusOngoing
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