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    Summary
    EudraCT Number:2010-021868-15
    Sponsor's Protocol Code Number:9785-CL-0222
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-15
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2010-021868-15
    A.3Full title of the trial
    A Randomized, Double-Blind, Phase II, Efficacy and Safety Study of MDV3100 (ASP9785) vs. Bicalutamide in Castrate Men with Metastatic Prostate Cancer
    A.3.2Name or abbreviated title of the trial where available
    Terrain
    A.4.1Sponsor's protocol code number9785-CL-0222
    A.5.4Other Identifiers
    Name:INDNumber:74,563
    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 SponsorAstellas Pharma Global Development, Inc. (APGD)
    B.1.3.4CountryUnited States
    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 supportAstellas Pharma Global Development, Inc. (APGD)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Global Development, Inc. (APGD)
    B.5.2Functional name of contact pointTeresa Sheehan, Clin. Study Manager
    B.5.3 Address:
    B.5.3.1Street Address1 Astellas Way
    B.5.3.2Town/ cityNorthbrook
    B.5.3.3Post codeIL 60062
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1224205-8252
    B.5.5Fax number+1847770-5482
    B.5.6E-mailteresa.sheehan@astellas.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 nameMDV3100
    D.3.2Product code MDV3100
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 915087-33-1
    D.3.9.2Current sponsor codeMDV3100
    D.3.9.3Other descriptive name3-(4-cyano-3-trifluoromethylphenyl)- 1-[3-fluoro-4-(methylcarbamoyl)phenyl]-5,5-dimethyl -2-thioxoimidazolin-4-one
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    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 RoleComparator
    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 Bicalutamide Tablets, USP
    D.2.1.1.2Name of the Marketing Authorisation holderZydus-Cadila
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameBicalutamide
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNBICALUTAMIDE
    D.3.9.1CAS number 90357065
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Prostate Cancer
    E.1.1.1Medical condition in easily understood language
    Metastatic 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 19.0
    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
    To determine the PFS of MDV3100 as compared to bicalutamide
    E.2.2Secondary objectives of the trial
    To determine the safety of treatment with MDV3100 as compared to bicalutamide;
    To determine the PSA response of MDV3100 at week 13 as compared to bicalutamide;
    To determine the time to PSA progression of MDV3100 as compared to bicalutamide.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional Pharmacogenomics Sub-Study is included into main protocol under Appendix 6.

    Objectice: to comprehensively analyze suspected disease-related genes and genes of relevance to clinical response, pharmacokinetics, and toxicity/safety issues, etc.
    E.3Principal inclusion criteria
    Inclusion Criteria for Double Blind Period
    1. IRB/IEC approved written Informed Consent and privacy language as per national
    regulations (e.g., HIPAA for U.S. sites) must be obtained from the subject prior to any
    study-related procedures (including withdrawal of prohibited medication, if applicable).
    2. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine
    differentiation or small cell features.
    3. Ongoing androgen deprivation therapy with a LHRH agonist or antagonist at a stable dose
    and schedule within 4 weeks of randomization or bilateral orchiectomy (i.e., surgical or
    medical castration).
    4. Serum testosterone level ≤ 1.7 nmol/L (50 ng/dL) at Screening.
    5. Metastatic disease documented on or before screening visit by one of the following:
     At least two bone lesions on bone scan, or
     Soft tissue disease documented by CT/MRI, or
     Unequivocal pelvic adenopathy short axis > 2.0 cm in diameter by CT/MRI.
    6. Progressive disease at study entry defined as one or more of the following three criteria
    occurring in the setting of castrate levels of testosterone:
     PSA progression defined by a minimum of three rising PSA levels with an
    interval of ≥ 1 week between each determination. The PSA value at the Screening
    visit should be ≥ 2 μg/L (2 ng/mL);
     Soft tissue disease progression defined by RECIST 1.1.;
     Bone disease progression defined by two or more new lesions on bone scan.
    7. Asymptomatic or mildly symptomatic from prostate cancer (i.e. the score on BPI-SF
    Question #3 must be < 4); no use of opiate analgesics for prostate cancer-related pain
    currently or anytime within 4 weeks prior to randomization.
    8. ECOG performance status of 0-1, including subjects with decreased performance status not
    attributed to progressive and symptomatic prostate cancer.
    9. Estimated life expectancy of ≥ 12 months.
    10. Able to swallow the study drug and comply with study requirements.
    Inclusion Criteria for Open Label Period:
    Subjects must meet the following inclusion criteria:
    1. IRB/IEC approved written Informed Consent and privacy language as per national regulations (e.g., HIPAA for U.S. sites) must be obtained from the subject prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
    2. Received double-blind study treatment during the study. If treated with enzalutamide during double-blind period, treatment must be ongoing at time of Open Label enrollment.
    3. Ongoing androgen deprivation therapy with a LHRH agonist or antagonist at a stable dose and schedule unless already had a bilateral orchiectomy.
    4. Able to swallow the study drug and comply with study requirements.
    5. A male subject and his female spouse/partner who is of childbearing potential must continue to use two acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) throughout the Open-Label Period, and for 3 months after final study drug administration. Two acceptable forms of birth control include:
    1. Condom (barrier method of contraception), AND
    2. In addition to a condom, one of the following acceptable forms of contraception is required:
    •Established use of oral, injected or implanted hormonal methods of contraception.
    •Placement of an intrauterine device (IUD) or intrauterine system (IUS).
    •Barrier methods of contraception: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
    •Tubal ligation for at least 6 months prior to initial double-blind screening
    • Vasectomy or other surgical castration at least 6 months prior to initial double blind screening
    6. Agrees to avoid sperm donation while taking enzalutamide.

    E.4Principal exclusion criteria
    Exclusion Criteria for Double Blind Period
    Prior cytotoxic chemotherapy for prostate cancer.
    Severe concurrent disease, infection, or comorbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment.
    Known or suspected brain and/or skull metastasis or active epidural disease.
    History of another malignancy within the previous 5 years other than curatively treated nonmelanomatous skin cancer.
    Current or prior treatment with estrogens and/or drugs with anti-androgenic properties such as spironolactone > 50 mg/kg, or progestational agents for the treatment of prostate cancer within 6 months prior to randomization.
    Current or prior use of ketoconazole for the treatment of prostate cancer.
    Use of antiandrogens within 6 weeks prior to randomization.
    Documented prior disease progression while receiving antiandrogens. Disease progression defined as PSA progression, radiographic progression and/or clinical deterioration.
    Current or prior treatment with 5-α reductase inhibitors or anabolic steroids within 6 months prior to randomization.
    Prior use of systemic glucocorticoids (the equivalent of 10 mg of prednisone) within 3 months prior to randomization or expectation of their use during the study.
    Radiation therapy to bone lesions or prostatic bed within 4 weeks prior to randomization.
    Major surgery within 2 months prior to randomization.
    History of seizure including febrile seizure or any condition that may predispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization). Also, current or prior treatment with anti-epileptic medications for the treatment of seizures or history of loss of consciousness or transient ischemic attack within 12 months prior to randomization.
    Clinically significant cardiovascular disease including Myocardial infarction within past six months or uncontrolled angina within past three months.
    Exclusion Criteria for Open Label Period:
    NOTE: The exclusion criteria apply only to subjects starting treatment with enzalutamide after receiving bicalutamide in the double-blind period.
    Subjects must not meet any of the following exclusion criteria:
    1.Has taken commercially available enzalutamide (Xtandi);
    2.Severe concurrent disease, infection, or comorbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment;
    3.Has current or previously treated brain metastasis or active leptomeningeal disease;
    4.Has a history of seizure or a condition that may increase the risk of seizure;
    5.Has any of the following: total bilirubin ≥ 1.5 times the ULN (except patients with a diagnosis of Gilbert’s disease), ALT or AST ≥ 2.5 times ULN at enrollment into open-label period. For patients with documented liver metastases, ALT and AST exclusion is > 5 times ULN;
    6.Has creatinine > 2 mg/dL (177 µmol/L) at enrollment into Open-label period.
    7.Met one or more discontinuation criteria in the double-blind period >30 days prior to enrollment in Open-Label Period.
    8.Use of another anti androgen, cytotoxic chemotherapy or other investigational drug within 4 weeks prior to Open-Label enrollment.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival
    E.5.1.1Timepoint(s) of evaluation of this end point
    The duration of progression-free survival (PFS) will be calculated from the date of randomization to the date of first objective evidence of radiographic disease progression, skeletal-related event, initiation of new anti-neoplastic therapy, or death by any cause, whichever occurs first. Subjects must be assessed with CT/MRI and bone scan within 28 days prior to randomization (Day 1). Scans should be scheduled in such a way that the scan results are available at the regularly scheduled visits at week 13, 25 and every subsequent 12 weeks.
    E.5.2Secondary end point(s)
    1)To determine the safety of treatment with MDV3100 as compared to bicalutamide
    2)To determine the prostate specific antigen (PSA) response of MDV3100 at week 13 as compared to bicalutamide
    3)To determine the time to PSA progression of MDV3100 as compared to bicalutamide

    E.5.2.1Timepoint(s) of evaluation of this end point
    1) at avery visit
    2) at week 13
    3) week, 13, 25 and every subsequent 12 weeks, 30 days from date of last dose, 60 days from date of last dose, Every 12 weeks from date of last dose
    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 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 Yes
    E.8.1.5Parallel group Yes
    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) Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Canada
    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
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months10
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 153
    F.4.2.2In the whole clinical trial 370
    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 Decision2012-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-08
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