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    Summary
    EudraCT Number:2018-000779-33
    Sponsor's Protocol Code Number:UMCN-AKF-18.01
    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:2018-03-19
    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 number2018-000779-33
    A.3Full title of the trial
    Effect of a reduced dose on cognitive side effects of enzalutamide in frail (m)CRPC patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can side effects of enzalutamide be prevented by using a reduced dose for frail (m)CRPC patients?
    A.4.1Sponsor's protocol code numberUMCN-AKF-18.01
    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 SponsorRadboud University Medical Center
    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 supportRadboud University Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud University Medical Center
    B.5.2Functional name of contact pointDepartment of Pharmacy
    B.5.3 Address:
    B.5.3.1Street Addressgeert grooteplein-zuid 10
    B.5.3.2Town/ citynijmegen
    B.5.3.3Post code6525GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031243617744
    B.5.5Fax number0031243668755
    B.5.6E-maildavid.burger@radboudumc.nl
    D. IMP Identification
    D.IMP: 1
    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 Xtandi
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas pharma europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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, soft
    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
    (Metastatic) Castration Resistant Prostate Cancer (mCRPC)
    (gemetastaseerd) castratieresistent prostaatkanker
    E.1.1.1Medical condition in easily understood language
    (metastatic) prostate cancer
    (uitgezaaide) prostaatkanker
    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 21.1
    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 determine the decrease in the CNS side effect fatigue in frail mCRPC patients treated with a reduced dose of enzalutamide (120mg OD) compared to the standard dose of enzalutamide (160mg OD) after 6 weeks of treatment
    E.2.2Secondary objectives of the trial
    To determine the decrease in the CNS side effect fatigue in frail mCRPC patients treated with a reduced dose of enzalutamide (120mg OD) compared to the standard dose of enzalutamide (160mg OD) after 12 weeks, and 24 weeks of treatment
    -To determine cognition impairment in frail mCRPC patients treated with a reduced dose of enzalutamide(120mg OD) compared to the standard dose of enzalutamide (160mg OD) after six weeks,12 weeks and 24 weeks of treatment
    -To evaluate changes in depression score in frail mCRPC patients treated with a reduced dose of enzalutamide(120mg OD) compared to the standard dose of enzalutamide (160mg OD) after six weeks, 12 weeks and 24 weeks of treatment
    -To correlate exposure (Ctrough) of enzalutamide and N-desmethylenzalutamide to the measured CNS side effects
    -To determine the percentage(%) of subjects that remained on the allocated dose level until the end of the study
    -To evaluate the effect of dose reduction on treatment efficacy according to PCWG3
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Frail male patients with PC who will start enzalutamide treatment within label
    - Age at least 18 years
    - Patient who are able and willing to give written informed consent prior to screening and enrolment
    - Patients from whom it is possible to collect blood samples and who are willing to answer the questionnaires
    - Life expectancy of > 6 months
    - Capable of understanding and answering Dutch tests and questionnaires, as determined by the investigator
    E.4Principal exclusion criteria
    -Other causes for cognition change:
    - (change in dose of opioids/sedatives/benzodiazepines) during last 2 weeks before study)
    -Use of psychostimulantia such as methylphenidate within 1 week of start of study
    -Diagnosed with medical conditions that affect cognition: Dementia, Alzheimer disease, Parkinson’s disease, psychiatric disorders that affect cognition other than depression or anxiety complaints related to the disease
    -Active infection or other comorbidities that may contribute to fatigue or cognition change within 4 weeks of study entry
    -Clinical relevant anaemia
    E.5 End points
    E.5.1Primary end point(s)
    The primary aim is to show that a reduced dose (120mg OD) results in less fatigue (measured by the change in FACIT-fatigue subscale score) after 6 weeks of therapy compared to the standard dose (160mg OD) for frail metastatic castration resistant prostate cancer patients.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks from start of therapy
    E.5.2Secondary end point(s)
    -To explore if the change in FACIT-fatigue subscale score is different between the two arms of the study from start of therapy; an early measurement of fatigue is performed at 6 weeks, and to explore if there remains a difference between the two arms from baseline - up untill 6 months of therapy, the questionnaire is repeated after 6 months of therapy.
    -To explore the change in FACIT-cognition subscale score over time: from baseline to 6 weeks, 12 weeks and 24 weeks after start of therapy between the two arms of the study (reduced dose vs standard dose)
    -To explore the change in GDS-15 subscale score over time: from randomization to 6 weeks, 12 weeks and 24 weeks after start of therapy between the two arms of the study (reduced dose vs standard dose)
    -To compare the percentage of patients that develop depression (score>5 ) on GDS-15 questionnaire between the two arms of the study (reduced dose vs standard dose) over time: after 6 weeks, 12 weeks and 24 weeks months after start if therapy
    -To correlate the change in side effects with plasma concentrations (Ctrough) of enzalutamide and N-desmethyl enzalutamide
    -To evaluate the proportion (%) of patients in control arm (standard dose) that remain on allocated dose level until the end of the study
    -To evaluate treatment efficacy for both arms of the study according to PCWG3
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 weeks, 12 weeks and 24 weeks
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 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
    Enzalutamide 160mg
    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 concerned4
    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 months
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state50
    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 Decision2018-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-05
    P. End of Trial
    P.End of Trial StatusOngoing
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