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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-001161-27
    Sponsor's Protocol Code Number:EUOG2014-001
    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:2015-04-13
    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 number2014-001161-27
    A.3Full title of the trial
    An Exploratory Phase 2, open-label, single-arm, efficacy and imaging Study of Oral Enzalutamide (MDV3100) Androgen Receptor (AR)-Directed Therapy in Chemo-Naïve patients with Progressive Prostate Cancer who have failed Androgen Deprivation Therapy (CRPC patients)
    Een onderzoek naar de effectiviteit van oral Enzalutamide in patienten met progressieve prostaatkanker die niet eerder met anti-androgenen zijn behandeld.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An exploratory study to assess the efficacy using imaging of oral Enzalutamide in patients with therapy-resistant prostate cancer who have not been treated with anti-androgens.
    Een onderzoek naar de effectiviteit van oral Enzalutamide in patienten met progressieve prostaatkanker die niet eerder met anti-androgenen zijn behandeld.
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberEUOG2014-001
    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 SponsorEuropean Uro- Oncology Group (EUOG)
    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 supportEUOG
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportAstellas
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEUOG
    B.5.2Functional name of contact pointProf. dr S. Osanto
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 ZA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31715269111
    B.5.5Fax number31715269111
    B.5.6E-mails.osanto@lumc.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 Xtandi
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas
    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 Tablet
    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
    Chemo-Naïve patients with Progressive Prostate Cancer who have failed Androgen Deprivation Therapy (CRPC patients)
    E.1.1.1Medical condition in easily understood language
    Prostate cancer not responding to anti-androgen
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To evaluate the feasibility of 18F-FDG PET/CT, or WB MRI or both to determine metastatic tumour load before and after treatment with Enzalutamide in CRPC patients.
    2. To evaluate how these 2 imaging modalities perform compared to traditional serial PSA measurements and bone scan in assessing metastatic tumour load, progressive disease and response to treatment in CRPC patients.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult patients with metastatic prostate cancer who are progressive on first-line ADT for metastatic disease and who have at least one measurable metastasis on either 18F-FDG PET/CT or WB MRI or both.
    E.4Principal exclusion criteria
    Previous chemotherapy / Known or suspected brain metastasis or active leptomeningeal disease / Evidence of clinically relevant liver/kidney disease/bone marrow failure / history of seizure or any condition that may predispose to seizure / history of loss of consciousness or transient ischemic attack within 12 months of enrolment / Contra-indication for MRI (e.g. pacemaker).
    E.5 End points
    E.5.1Primary end point(s)
    Progression-Free Survival (PFS) at 6 and 12 months
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 and 12 months
    E.5.2Secondary end point(s)
    Biochemical (PSA) response defined as prostate-specific antigen (PSA) nadir. PSA progression. PSA kinetics measured by PSA doubling time (regular PSA measurements). Progression of bone lesions detected with bone scan according to Prostate Cancer Working Group 2 (PCWG2) criteria. Radiologically confirmed spinal cord compression or pathological fracture due to malignant progression. A Symptomatic Skeletal Event (SSE) is defined as external beam radiation therapy (EBRT) to relieve skeletal pain, new symptomatic pathologic bone fracture, occurrence of spinal cord compression or tumour-related orthopedic surgical intervention, or change of anti-neoplastic therapy to treat bone pain. CTC measurements and comparison with radiological PFS at 6 and 12 months. Circulating testosterone (T), dihydrotestosterone (DHT), sex hormone binding globulin (SHBG), androstenedione, DHEA, luteinizing hormone (LH), follicle stimulating hormone (FSH), prolactin and estradiol assessed as temporal changes of absolute values and temporal percentage changes of baseline values. Biomarker assessment / correlative: (next to PSA) biomarkers of bone turnover, Alkaline Phosphatase, PTH, Ca, Phosphate, 25 (OH)Vitamin D, beta-CTX (beta-crosslaps), PN1P. The safety of Enzalutamide as assessed by serious adverse events (SAEs), severity of adverse events (AEs) graded by National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE), discontinuation due to AEs, as well as new clinically significant changes in physical exam findings, vital signs, laboratory values, and ECGs. Time to symptomatic progression (including death due to prostate cancer) Time to first radiological or symptomatic progression Time to initiation of salvage systemic therapy, including chemotherapy, or palliative radiation Quality of life measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire and by the EuroQol 5-Dimension QoL Instrument (EQ-5D) Changes in Karnofsky score/ECOG score Changes in visual analogue scale (VAS) for tumour-related pain Changes in BMD as measured by DXA scan. Early Health Technology Assessment to calculate cost-effectiveness of both diagnostic procedures.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 and 12 months
    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 No
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Detection of tumour deposits/metastatic sites in metastatic prostate cancer using advanced imaging modalities
    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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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 Decision2015-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-30
    P. End of Trial
    P.End of Trial StatusOngoing
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