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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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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    EudraCT Number:2019-003618-15
    Sponsor's Protocol Code Number:BAY1841788/20321
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-07-16
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedPortugal - INFARMED
    A.2EudraCT number2019-003618-15
    A.3Full title of the trial
    An open-label, single arm, roll-over study to provide continued treatment with darolutamide in participants who were enrolled in previous Bayer-sponsored studies
    Ensaio de roll-over, aberto e de braço único, para proporcionar a continuidade do tratamento com darolutamida aos participantes de ensaios anteriores promovidos pela Bayer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open study for participants who have been on darolutamide treatment in any other Bayer study.
    Ensaio aberto para participantes em tratamento com darolutamida em qualquer outro ensaio da Bayer
    A.3.2Name or abbreviated title of the trial where available
    Darolutamide roll-over study
    Ensaio de roll-over da darolutamida
    A.4.1Sponsor's protocol code numberBAY1841788/20321
    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 SponsorBayer Consumer Care AG
    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 supportBayer Consumer Care AG
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.4Telephone number4930300139003
    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. name NUBEQA 300 mg comprimidos revestidos por película
    D. of the Marketing Authorisation holderBayer AG
    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.3.1Product nameDarolutamide
    D.3.2Product code BAY 1841788
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 1297538-32-9
    D.3.9.2Current sponsor codeBAY 1841788
    D.3.9.3Other descriptive nameODM-201
    D.3.9.4EV Substance CodeSUB185326
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Cancro da próstata
    E.1.1.1Medical condition in easily understood language
    Non-metastatic or metastatic cancer
    Cancro metastático ou não-metastático
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Continuation of darolutamide treatment
    • Safety of darolutamide
    - Continuação do tratamento com Darolutamida
    - Segurança da Darolutamida
    E.2.2Secondary objectives of the trial
    • Documentation of tolerability of darolutamide
    - Documentação da tolerabilidade da Darolutamida
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
    2. Participants enrolled in any Bayer-sponsored darolutamide feeder study at the time of study closure or primary completion, who are currently receiving darolutamide and are experiencing clinical benefit from treatment.
    3. Participants who have not met any treatment discontinuation criteria outlined in the feeder study protocol.
    4. Willingness to continue practicing acceptable methods of contraception and birth
    control when sexually active with pregnant women during the study and for 1 week
    after completion of study treatment. Participants must use effective contraception
    while on treatment and for 3 months after completion of study treatment when
    sexually active with women of child bearing potential (WOCBP).
    1. Capaz de dar o consentimento informado escrito incluindo conformidade com os requisitos listados no formulário de consentimento informado (PIIC) e no protocolo
    2. Participantes inscritos em qualquer ensaio da Bayer com Darolutamida no momento de encerramento do ensaio ou conclusão primária, que estejam a receber atualmente Darolutamida e que estejam a beneficiar clinicamente do tratamento
    3. Participantes que não tenham atingido nenhum critério de descontinuação delineado no protocolo do ensaio primário
    4. Vontade de continuar a praticar métodos contracetivos aceitáveis e de controlo de natalidade quando sexualmente ativo com mulheres grávidas durante o ensaio e por 1 semana após a conclusão do tratamento do ensaio. Os participantes devem utilizar métodos contraceptivos eficazes durante o tratamento e durante 3 meses após a conclusão do tratamento do ensaio quando sexualmente ativos com mulheres em idade fértil (MEIF). Por favor consultar secção 8.3.5 para detalhes específicos e uma lista de métodos contracetivos altamente efcazes.
    E.4Principal exclusion criteria
    1. Participant is unable to comply with the requirements of the study.
    2. Negative benefit/ risk ratio as determined by the investigator.
    3. Meet any criteria for treatment discontinuation of the feeder study the participant is coming from.
    1. Particpante é incapaz de cumprir com os requerimentos do ensaio
    2. Racio negativo da proporção risco/benefício determinado pelo Investigador
    3. Preencher qualquer um dos critérios para descontinuação de tratamento no ensaio primário no qual se encontrava a participar
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence of TEAEs (Treatment-emergent adverse events)
    • Incidence of TESAEs (Treatment-emergent serious adverse events)
    • Incidence of drug-related TEAEs and TESAEs
    - incidência de EAET (eventos adversos emergentes do tratamento)
    - incidência de EAGET (eventos adversos graves emergentes do tratamento)
    - incidência de EAETs e EAGETs relacionados com o medicamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    These will be summarized formally at the end of the study when all patients are complete.
    Serão sumarizados formalmente no final do ensaio quando todos os participantes tiverem completado o ensaio
    E.5.2Secondary end point(s)
    • Frequency of dose modifications
    Frequência de modificações de dose
    E.5.2.1Timepoint(s) of evaluation of this end point
    These will be summarized formally at the end of the study when all patients are complete.
    Estes serão sumarizados formalmente no final do estudo quando todos os doentes tiverem completado o ensaio.
    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 Yes
    E.6.5Efficacy No
    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
    The purpose of this study is to enable participants who are receiving darolutamide in any Bayer-sponsored feeder study, and assessed by the investigator to be benefitting, to continue to receive darolutamide treatment beyond the feeder study primary completion or closure.
    O objetivo deste ensaio é permitir que os participantes que estavam a receber darolutamida em qualquer um dos ensaios anteriores promovidos pela Bayer e que, de acordo com o investigador, estavam a beneficiar do tratamento, continuem a receber o tratamento com darolutamida para além da conclusão primária ou do encerramento do ensaio preliminar.
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA255
    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
    Korea, Republic of
    Russian Federation
    South Africa
    United States
    United Kingdom
    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
    The end of the study is defined as the date when the last participant from the last feeder study has completed the roll-over study or the sponsor has decided to close the trial.
    O final do ensaio é definido como a data em que o último participante do ensaio primário tiver completado o ensaio de roll over ou o Promotor tiver decidido encerrar o ensaio
    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 months11
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days18
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 410
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 430
    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)
    There is no protocol specified planned treatment following the end of the study. Participants should receive subsequent treatments according to the local standard of care.
    Não existe tratamento especifico definido em protocolo no seguimento do fim do ensaio. Os participantes devem receber o tratamento subsequente de acordo com o padrão local de cuidado.
    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 Decision2020-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-21
    P. End of Trial
    P.End of Trial StatusCompleted
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