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    Summary
    EudraCT Number:2020-005087-66
    Sponsor's Protocol Code Number:75669
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-14
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-005087-66
    A.3Full title of the trial
    The Effect of Enzalutamide on Oxycodone Metabolism in Men with Prostate Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Effect of the Concomitant Use of Enzalutamide and Oxycodone.
    A.3.2Name or abbreviated title of the trial where available
    the ENZYME study
    A.4.1Sponsor's protocol code number75669
    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 SponsorDeventer Hospital
    B.1.3.4CountryNetherlands
    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 supportDeventer Hospital
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDeventer Hospital
    B.5.2Functional name of contact pointSuzan Detert Oude Weme
    B.5.3 Address:
    B.5.3.1Street AddressNico Bolkesteinlaan 75
    B.5.3.2Town/ cityDeventer
    B.5.3.3Post code7416 SE
    B.5.3.4CountryNetherlands
    B.5.6E-mails.detertoudeweme@dz.nl
    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 Oxycodone
    D.2.1.1.2Name of the Marketing Authorisation holderAurobindo
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    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 21.1
    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 PT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10036911
    E.1.2Term Prostate cancer recurrent
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10036912
    E.1.2Term Prostate cancer stage 0
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10036917
    E.1.2Term Prostate cancer stage I
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10036918
    E.1.2Term Prostate cancer stage II
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10036919
    E.1.2Term Prostate cancer stage III
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10036920
    E.1.2Term Prostate cancer stage IV
    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 21.1
    E.1.2Level PT
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10071119
    E.1.2Term Hormone-dependent 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 investigate the effect of enzalutamide on the pharmacokinetics (PK) of oxycodone following a single 15 mg oral dose of normal-release oxycodone in men with prostate cancer, expressed in Cmax and AUC0-t.
    E.2.2Secondary objectives of the trial
    1. To investigate the effect of enzalutamide on the pharmacokinetics (PK) of oxycodone following a single 15 mg oral dose of normal-release oxycodone in men with prostate cancer, expressed in AUC0-∞ and t1/2.
    2. To investigate the effect of enzalutamide on the pharmacokinetics (PK) of oxycodone its metabolites noroxycodone, oxymorphone and noroxymorphone following a single 15 mg oral dose of normal-release oxycodone in men with prostate cancer, expressed in Cmax, AUC0-t, AUC0-∞ and t1/2.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Males aged ≥ 18 years;
    - Diagnosed prostate cancer;
    - Treated with enzalutamide 160 mg once daily for 40 days (arm 1)
    E.4Principal exclusion criteria
    - a body mass index (BMI) outside the range of 18 to 30 kg/m2;
    - known metastases in the liver that would affect drug metabolism;
    - Child-Pugh classification B or C that would affect drug metabolism;
    - known CYP3A4 or CYP2D6 polymorphisms that would affect drug metabolism (patients with a known CYP3A4 or CYP2D6 polymorphism afterwards will be replaced);
    - known moderate-severe renal dysfunction (GFR <60 ml/min/1.73m2) that would affect drug metabolism;
    - gastrointestinal disorders that would potentially alter absorption;
    - previous gastric bypass or gastric band surgery;
    - known allergy, hypersensitivity or intolerance to normal-release oxycodone;
    - a history of drug abuse or treatment for abuse;
    - dose-reduction or ≥5 successive days of treatment interruption of enzalutamide within 40 days prior to the study day (arm 1);
    - treatment with enzalutamide within 40 days prior to the study day (arm 2);
    - use of oxycodone normal-release within 48 hours prior to oxycodone intake or use of oxycodone extended-release within 4 days prior to oxycodone intake;
    - use of other medication that would affect oxycodone metabolism, see section 5.2 and appendix B;
    - use of other medication that would affect enzalutamide metabolism, see section 5.2 and appendix B (arm 1).
    E.5 End points
    E.5.1Primary end point(s)
    Maximum serum concentration (Cmax) and Area under the serum concentration versus time curve from time zero to the time (t) corresponding to the last quantifiable concentration (AUC0-t) of oxycodone
    E.5.1.1Timepoint(s) of evaluation of this end point
    Plasma sampling at t=0.5, 1, 1.5, 2, 3, 5, 8 hours after intake of oxycodone.
    Evaluation of the endpoint will be done after completion of all plasma samples.
    E.5.2Secondary end point(s)
    1. Maximum serum concentration (Cmax) of noroxycodone, oxymorphone and noroxymorphone;
    2. Area under the serum concentration versus time curve from time zero to the time (t) corresponding to the last quantifiable concentration (AUC0-t) of noroxycodone, oxymorphone and noroxymorphone;
    3. Area under the concentration-time curve from time zero to infinity with extrapolation of the terminal phase (AUC0-∞) of oxycodone and its metabolites noroxycodone, oxymorphone and noroxymorphone;
    4. Terminal half-life (t1/2) of oxycodone and its metabolites noroxycodone, oxymorphone and noroxymorphone.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Plasma sampling at t=0.5, 1, 1.5, 2, 3, 5, 8 hours after intake of oxycodone.
    Evaluation of the endpoint will be done after completion of all plasma samples.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Oxycodone taken in prostate cancer patients treated vs not treated with enzalutamide
    E.8.2.4Number of treatment arms in the trial2
    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 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 years
    E.8.9.1In the Member State concerned months18
    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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state24
    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 Decision2020-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-14
    P. End of Trial
    P.End of Trial StatusOngoing
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