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    The EU Clinical Trials Register currently displays   38927   clinical trials with a EudraCT protocol, of which   6396   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-004513-90
    Sponsor's Protocol Code Number:UMCN-AKF-14.07
    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:2015-01-15
    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 number2014-004513-90
    A.3Full title of the trial
    Optimizing abiraterone (Zytiga®) therapy by exploring the relation between an early biomarker - drug exposure - as a predictor for drug response in patients with mCRPC (OPTIMUM - STUDY)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Is monitoring of plasmalevels of abiraterone a possible predictor for the response to Abiraterone treatment, in patients with metastatic prostate cancer?
    Is de bloedconcentratie van abirateron van voorspellende waarde voor het effect van dit geneesmiddel in patiënten met uitgezaaid prostaatkanker?
    A.3.2Name or abbreviated title of the trial where available
    OPTIMUM
    A.4.1Sponsor's protocol code numberUMCN-AKF-14.07
    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 UMC
    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 supportJanssen BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboudUMC
    B.5.2Functional name of contact pointApotheek
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.6E-mailmettebenoist@radboudumc.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 Zytiga
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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
    Metastatic Castration Resistant Prostate Cancer (mCRPC)
    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 19.1
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate a relation of abiraterone exposure (area under the curve) with treatment response (following RECIST criteria for complete remission, partial remission and stable disease, primarily based on radiographic response and secondary on biochemistry (≥25% decrease in PSA).
    E.2.2Secondary objectives of the trial
    -To explore the relation between novel early and easily assessable biomarkers (PSA-mRNA, PCA3-mRNA, TMPRSS2:ERP gene fusion-mRNA, (currently under development)ARv7 mRNA and ARwt mRNA) and treatment response after 3 months and 6 months of therapy
    -To explore whether the degree of reductions of these novel biomarkers are related to abiraterone exposure (AUC) after 3 and 6 months of therapy
    -To explore the relation between traditional PD biomarkers (serum PSA, DHEA, LDH, AP) and treatment response after 3 and 6 months of therapy
    -To explore whether the degree of reductions in PSA, DHEA, LDH, AP are related to abiraterone exposure (AUC) after 3 and 6 months of therapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - patients with metastatic castration resistant prostate cancer* who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated – OR – who have been treated upfront with 6 cycles of docetaxel: conform the Chaarted or Stampede trials- Age ≥18 years
    - Feasible to collect blood samples from
    - Life expectancy of > 6 months
    - Measurable disease
    - Able and willing to give written informed consent prior to screening and enrollment
    *definition of CRPC according to EAU guidelines 2014
    E.4Principal exclusion criteria
    The study objective is to explore the effect of abiraterone exposure on treatment and biomarker response in group of patients treated with abiraterone acetate in agreement with the drug label. Therefore the exclusion criteria as listed in the package insert will be used in this study. Additionally, patients are not allowed to be treated with other anticancer therapies, potent CYP3A4 inhibitors or inducers and herbal medicine that could interfere with abiraterone exposure.
    E.5 End points
    E.5.1Primary end point(s)
    To demonstrate a relation of abiraterone exposure (area under the curve) with treatment response
    E.5.1.1Timepoint(s) of evaluation of this end point
    Respons Assessment: Day 84(±4d) ; Day 168(±4d)

    Pharmacokinetics: Day 28(±2d) ; Day 84(±4d) ; Day 168(±4d)

    E.5.2Secondary end point(s)
    -To explore the relation between novel early and easily assessable biomarkers (PSA-mRNA, PCA3-mRNA, TMPRSS2:ERP gene fusion-mRNA, (currently under development)ARv7 mRNA and ARwt mRNA) and treatment response after 3 months and 6 months of therapy
    -To explore whether the degree of reductions of these novel biomarkers are related to abiraterone exposure (AUC) after 3 and 6 months of therapy
    -To explore the relation between traditional PD biomarkers (serum PSA, DHEA, LDH, AP) and treatment response after 3 and 6 months of therapy
    -To explore whether the degree of reductions in PSA, DHEA, LDH, AP are related to abiraterone exposure (AUC) after 3 and 6 months of therapy
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pharmacodynamics(biomarkers assessment): Day 28(±2d) ; Day 84(±4d) ; Day 168(±4d)
    Pharmacokinetics: Day 28(±2d) ; Day 84(±4d) ; Day 168(±4d)
    Treatment response: Day 84(±4d) ; Day 168(±4d)
    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 Yes
    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) 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 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 concerned3
    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 years3
    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 years3
    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 Decision2015-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-17
    P. End of Trial
    P.End of Trial StatusOngoing
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