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    Summary
    EudraCT Number:2010-022802-41
    Sponsor's Protocol Code Number:3104001
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-15
    Trial results View 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 ConcernedFinland - Fimea
    A.2EudraCT number2010-022802-41
    A.3Full title of the trial
    SAFETY AND PHARMACOKINETICS OF ODM-201 IN PATIENTS WITH CASTRATE RESISTANT PROSTATE CANCER: OPEN, NON-RANDOMISED, UNCONTROLLED, MULTICENTRE, MULTIPLE DOSE ESCALATION STUDY WITH A RANDOMISED PHASE II EXPANSION COMPONENT
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SAFETY, ABSORPTION AND DISTRIBUTION OF ODM-201 IN PATIENTS WITH PROSTATE CANCER:
    A.3.2Name or abbreviated title of the trial where available
    Arades Phase I/II
    A.4.1Sponsor's protocol code number3104001
    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 pointVirpi Mononen
    B.5.3 Address:
    B.5.3.1Street AddressOrionintie 1
    B.5.3.2Town/ cityEspoo
    B.5.3.3Post codeFI 02101
    B.5.3.4CountryFinland
    B.5.4Telephone number+358509663288
    B.5.5Fax number +358 10 426 2896
    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-201
    D.3.2Product code ODM-201
    D.3.4Pharmaceutical form Capsule
    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 INN.
    D.3.9.2Current sponsor codeODM-201
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Progressive castration resistant prostate cancer (MedDRA: hormone-refractory prostate cancer)
    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 10062904
    E.1.2Term Hormone-refractory 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 evaluate safety and tolerability of ODM-201 and to define dose(s) of ODM-201 for further clinical studies. Dose-limiting toxicities (DLT) and the MTD and/or OTD will be determined.
    E.2.2Secondary objectives of the trial
    To evaluate PK profile of ODM-201 (by using the sum of diastereomers concentrations) and its major metabolite after single and multiple dose administartions in fed condition at different dose level. Preliminary antitumor activity of ODM-201 will be evaluated by PSA, soft tissue and bone lesions, circulating tumor cell (CTC) counts, ECOG performance status, and by the time on treatment. As well as to evaluate the effects of ODM-201 on concentration of serum bone markers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent (IC) obtained.
    2.Male patients aged 18 years or older.
    3.Histologically confirmed adenocarcinoma of prostate.
    4.Ongoing androgen deprivation therapy with a LHRH analogue or antagonist or bilateral orchiectomy and serum testosterone level < 50 ng/dl (< 0.5 ng/ml, < 1.7 nmol/l) at screening.
    5.Progressive metastatic disease during the androgen deprivation, and after the treatment with antiandrogen and antiandrogen withdrawal, demonstrated by 1 or more of the following criteria:
    •patients with measurable or non-measurable disease (i.e. no target lesions), progression defined by a new soft tissue lesion or rising PSA value over 2 ng/ml in at least 2 rising successive measurements, at least 1 week apart. If the confirmatory PSA value is less than the screening PSA value, then an additional test for the rising PSA is required to document progression.
    •patients with measurable disease, progression defined by RECIST 1.1 criteria.
    •patients with metastatic bone disease, progression defined by 2 or more new lesions in a radionuclide bone scan.
    6.The patient:
    •has received 1 or 2 chemotherapy treatments, or
    •is ineligible for chemotherapy, or
    •is intolerant of chemotherapy, or
    •has declined chemotherapy, or
    •has no need for chemotherapy yet.
    7.The patient has ECOG performance status of 0-1 at screening.
    8.The patient has at screening blood counts:
    •absolute neutrophil count ≥ 1.5 x 109/l),
    •thrombocytes ≥ 100 x 109/l),
    •haemoglobin ≥ 10 g/dl (can be post-transfusion).
    9.The patient has at screening liver, renal and albumin values of:
    •alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN),
    •total bilirubin ≤ 2 x ULN,
    •creatinine ≤ 1.5 x ULN,
    •albumin > 3.0 g/dl
    10.Prior treatment with antiandrogen. Discontinuation of bicalutamide or nilutamide at least 6 weeks and other antiandrogens at least 4 weeks prior to the start of the study treatment.
    11.Life expectancy of at least 3 months.
    12.Sexually active patients must agree to use condoms as an effective barrier method during the study treatment and for 3 months after the end of the treatment
    E.4Principal exclusion criteria
    1.Known hypersensitivity to the study treatment formulation excipients.
    2.The patient has received prior therapy with MDV3100 or any investigational AR antagonist.
    3.The patient has received chemotherapy, radiotherapy or any experimental therapy within 4 weeks (within 6 weeks for nitrosoureas and mitomycin C) of the start of the study treatment or has not recovered to grade ≤ 1 or returned to baseline from any acute treatment-related toxicities of the previous therapy except for alopecia and grade 2 neuropathy.
    4.Initiation of bisphosphonate therapy within 4 weeks prior to the start of the study treatment. Patients on a stable dose of bisphosphonate for at least for 30 days prior to the start of the study treatment can continue the treatment during the study.
    5.Therapy with estrogen within 30 days prior the start of the study treatment. 6.Therapy with oral ketoconazole or CYP17 inhibitor within 30 days prior to the start of the study treatment.
    7.Use of systemic corticosteroid with dose greater than the equivalent of 10 mg of prednisone/day within 30 days prior to the start of the study treatment. Patients on a stable maintenance dose of corticosteroid ≤ 10 mg/day can continue the treatment during the study.
    8.Prior use of any herbal products known to decrease PSA levels (e.g. PC-SPES or saw palmetto) within 30 days prior the start of the study treatment.
    9.Known metastases in the brain.
    10.History of other malignancy within the previous 5 years, except a basal cell carcinoma of skin.
    11.Major surgery within 4 weeks prior to the start of the study treatment. 12.Serious persistent infection within 14 days prior to the start of the study treatment.
    13.Known gastrointestinal disease or procedure that affects the absorption of the study treatment.
    14.Serious concurrent medical condition or psychiatric illness.
    15.History of congestive heart failure New York heart association (NYHA) class III or IV or uncontrolled hypertension at screening.
    16.History or family history of long QTc syndrome.
    17.Abnormalities in centrally read 12-lead ECG considered by the investigator to be clinically significant or PR interval > 200 ms or prolongation or shortening of the rate-corrected (Fridericia) QT interval (repeated demonstration of QTc interval > 450 ms or < 300 ms) at screening
    18.The patient has received any investigational treatment within 30 days prior to the start of the study treatment.
    19.Known history of hepatitis B, or hepatitis C.
    20.Any condition that, in the opinion of the investigator, would impair the patient's ability to comply with study procedures.
    21.The patient is not able to swallow the study treatment capsules.
    E.5 End points
    E.5.1Primary end point(s)
    To establish a dose limiting toxicity or maximum tolerated dose (MTD), if possible, by assessing the adverse events using the NCI CTCAE version 4.03.
    E.5.1.1Timepoint(s) of evaluation of this end point
    DLT (and MTD if possible) at 28 days time point in each cohort. Safety-tolerability at the end of the study at 12 weeks timepoint
    E.5.2Secondary end point(s)
    To evaluate PK profile after single and multiple dose administrations in fed condition at different dose levels.
    Preliminary antitumour activity will be evaluated by PSA, soft tissue and bone
    lesions, CTC counts, ECOG performance status, and by the time on treatment.
    The dose(s) of ODM-201 for further clinical studies will be defined.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK. Phase 1: Days 1, 7, 14, 21, 28; Phase 2: day 28 and week 12.
    Phase 1 & phase 2: PSA, soft tissue and bone lesions, CTC counts, ECOG performance status at 12 weeks timepoint.
    Phase 2: additionally AR gene mutations from CTC at day 1
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    Finland
    France
    United Kingdom
    United States
    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
    For all patients (including discontinued patients) there is a 4-week post treatment period after the end of the study treatment. After this, the end-of-study visit will take place. (For those patients continuing in study 3104002, the end-of-study procedures will be performed when the patient finishes that study.)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 65
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 130
    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)
    After 12 weeks the patients who have a stable disease and continue to meet the inclusion and exclusion criteria of this study may continue the treatment until disease progression or intolerability in an open extension study 3104002 by the approval of the investigator.
    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 Decision2012-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-18
    P. End of Trial
    P.End of Trial StatusCompleted
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