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    EudraCT Number:2010-021529-11
    Sponsor's Protocol Code Number:EMR62242-006
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-12-21
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2010-021529-11
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multicenter Phase II trial investigating two doses of EMD 525797 in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC).
    Estudio de fase II multicéntrico, aleatorizado, doble ciego y controlado con placebo para investigar dos dosis de EMD 525797 en pacientes asintomáticos o con sintomatología leve, con cáncer de próstata metastásico resistente a la castración (CPRCm).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study in prostate cancer using a monoclonal antibody
    Ensayo clínico en cancer de prostata en el que se utiliza un anticuerpo monoclonal
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberEMR62242-006
    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 SponsorMerck KGaA
    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 supportMerck KGaA
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Centre Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Strasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    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 No
    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 nameDI17E6
    D.3.2Product code EMD 525797
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeEMD525797
    D.3.9.3Other descriptive nameDI17E6
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D. medicinal product typehumanized antibody (deimmunized IgG2)
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC)
    Pacientes con cáncer de próstata metastásico resistente a la castración (CPRCm) asintomático o con sintomatología leve.
    E.1.1.1Medical condition in easily understood language
    subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC)
    Pacientes con cáncer de próstata metastásico resistente a la castración (CPRCm) asintomático o con sintomatología leve.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    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 14.1
    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
    The primary objective of the trial is to evaluate whether EMD 525797 administered as 1-hour intravenous (i.v.) infusion every 3 weeks is superior to placebo in terms of progression free survival (PFS) time in subjects with asymptomatic or mildly symptomatic mCRPC.
    El objetivo principal de este estudio es evaluar si la administración de EMD 525797 en infusión intravenosa (i.v.) durante 1 hora cada 3 semanas es mejor que el placebo en cuanto al tiempo de supervivencia libre de progresión (SLP) en sujetos con CPRCm asintomático o con sintomatología leve.
    E.2.2Secondary objectives of the trial
    To further evaluate the efficacy of EMD 525797
    - To further characterize the safety profile of EMD 525797
    - To further evaluate the pharmacokinetic (PK) profile of EMD 525797
    - To explore the relationship between number and/or changes of numbers of circulating tumor cells (CTCs) and the clinical outcome (e.g., primary and secondary endpoints).
    ? Profundizar en la evaluación de la eficacia de EMD 525797
    ? Definir mejor el perfil de seguridad de EMD 525797
    ? Definir mejor el perfil farmacocinético (FC) de EMD 525797
    ? Explorar la relación entre el número y/o el cambio del número de células tumorales circulantes (CTC) y el desenlace clínico (es decir, los criterios de valoración principales y secundarios).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects with asymptomatic or mildly symptomatic mCRPC with progression of bone metastasis (new bone lesion(s)) by bone scan within 4 weeks (28 days) prior to randomization will be eligible for this trial. Subjects must fulfill ALL of the following inclusion criteria:
    1. Signed and dated written informed consent prior to any specific trial procedure.
    2. Age ?18 years, male.
    3. Histologically or cytologically confirmed adenocarcinoma of the prostate (Gleason score).
    4. Radiological progression of bone lesion(s) with or without soft tissue lesions within 4 weeks (28days) prior to randomization.
    5. Stable, ongoing adequate testosterone suppression proven by hypogonadal levels of testosterone (?50 ng/dL) for subjects without surgical castration. Testosterone level will not be documented for subjects who have been surgically castrated.
    6. Bisphosphonate treatment has to be initiated at least 2 days prior to start of treatment with EMD 525797.
    7. Eastern Cooperative Oncology Group performance status <2.
    8. Adequate hematological function: Absolute Neutrophil Count (ANC) ?1.5 x 109/L; platelets ?100 x 109/L; hemoglobin ?9 g/dL (without transfusion).
    9. Adequate hepatic function: total bilirubin ?1.5 x upper limit of normal (ULN); aspartate transaminase (ASAT) ?5 x ULN and alanine aminotransferase (ALAT) ?5 x ULN.
    10. Creatinine clearance ?40 mL /min (calculation based on Cockcroft-Gault formula).
    11. International Normalized Ratio (INR) and activated partial thromboplastin time (aPTT) within normal range.
    12. Effective contraception, e.g., double barrier method, if the risk of conception exists.
    13. Ability to comply with the trial and follow-up procedures.
    14. Tumor material (from tumor block or punch biopsy) availability must be confirmed at screening. The sample should be collected and sent to the laboratory as soon as possible, ideally by the time of randomization.
    Los sujetos con CPRCm asintomático o con sintomatología leve con progresión de las metástasis óseas (nuevas lesiones óseas) en la gammagrafía ósea obtenida en las 4 semanas (28 días) previas a la aleatorización se considerarán candidatos para este estudio. Los pacientes deberán cumplir TODOS los criterios de inclusión siguientes:
    1. Consentimiento informado por escrito, firmado y fechado antes de realizar cualquier procedimiento específico del estudio.
    2. Edad ? 18 años y sexo masculino.
    3. Adenocarcinoma de próstata, confirmado por histología o por citología (puntuación de Gleason).
    4. Progresión radiológica de las lesiones óseas, con o sin lesiones en partes blandas, en las 4 semanas (28 días) previas a la aleatorización.
    5. Supresión estable y continua adecuada de la testosterona, demostrada por las concentraciones hipogonadales de la misma (? 50 ng/dl) en los sujetos sin castración quirúrgica. La concentración de testosterona no se documentará en los sujetos que se hayan sometido a castración quirúrgica.
    6. El tratamiento con bifosfonato debe haberse iniciado al menos 2 días antes de iniciar el tratamiento con EMD 525797.
    7. Estado funcional del Eastern Cooperative Oncology Group < 2.
    8. Función hematológica adecuada: recuento absoluto de neutrófilos (RAN) ? 1,5 x 109/l; plaquetas ? 100 x 109/l; hemoglobina ? 9,0 g/dl (sin transfusión).
    9. Función hepática adecuada: bilirrubina total ? 1,5 x LSN (límite superior de la normalidad); aspartato aminotransferasa (ASAT) ? 5 x LSN y alanina aminotransferasa (ALAT) ? 5 x LSN.
    10. Aclaramiento de creatinina ? 40 ml/min (calculado con la fórmula de Cockcroft-Gault).
    11. Cociente internacional normalizado (INR) y tiempo de tromboplastina parcial activada (TTPa) dentro del intervalo normal
    12. Anticoncepción eficaz, por ejemplo, con un método de doble barrera, si existe riesgo de concepción.
    13. Capacidad para cumplir con los procedimientos del ensayo y del seguimiento.
    14. La disponibilidad de muestra tumoral (de un bloque del tumor o de una biopsia por perforación) debe confirmarse en la selección. La muestra debe obtenerse y enviarse al laboratorio en cuanto sea posible, idealmente en el momento de la aleatorización.
    E.4Principal exclusion criteria
    Subjects are not eligible for this trial if they meet any of the following exclusion criteria:
    1. Acute pathologic fracture, spinal cord compression, or hypercalcemia at Screening.
    2. Nonsteroidal antiandrogens, e.g., flutamide and bicalutamide, within 30 days before treatment.
    3. Chronic and ongoing treatment with opioids (treatment >10 days).
    4. Prior chemotherapy, biologic therapy (targeted therapy), or
    any experimental therapy for mCRPC.
    5. Radiotherapy to bone lesions and/or orthopedic surgery for pathologic fractures. Any kinds of major elective surgery within 30 days prior to trial treatment.
    6. Chronic supraphysiologic doses of oral steroids, defined as >10 mg of prednisone equivalents per day.
    7. Confirmed or clinically suspected brain metastases.
    8. Visceral metastasis.
    9. Known hypersensitivity reactions to any of the excipients of the trial medication.
    10. History of allergic reactions to any other monoclonal antibody therapy.
    11. Uncontrolled hypertension defined as systolic blood pressure ?160 mmHg and/or diastolic blood pressure ?100 mmHg under resting conditions for at least 5 minutes.
    12. Chronic daily acetylsalicylic acid (ASS) therapy at doses >100 mg.
    13. Bleeding disorders and/or history of thromboembolic events (history of superficial thrombophlebitis is not an exclusion criterion).
    14. Treatment with thrombolytics or oral or parenteral anticoagulants within 10 days prior to trial treatment.
    15. Severe peripheral vascular disease or ulceration; unstable angina pectoris, or myocardial infarction within 6 months before start of trial treatment, clinically significant abnormal electrocardiogram (ECG) at screening.
    16. Known alcohol or drug abuse.
    17. Participation in another clinical trial within 30 days before start of trial treatment.
    18. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
    19. Hepatitis B or C, human immunodeficiency virus (HIV) infection, active or chronic.
    20. Legal incapacity or limited legal capacity.
    21. All other significant diseases which, in the opinion of the Investigator, might impair the subject?s tolerance of trial treatment.
    22. Other malignancy if treatment has not been completed within 2 years before start of trial treatment.
    Los pacientes no son elegibles para este estudio si cumplen cualquiera de los siguientes criterios de exclusión:
    1. Fractura patológica aguda, compresión de la médula espinal o hipercalcemia en el proceso de selección.
    2. Antiandrógenos no esteroideos, como flutamida y bicalutamida, en los 30 días antes del tratamiento.
    3. Tratamiento crónico y continuado con opioides (tratamiento > 10 días).
    4. Quimioterapia, tratamiento biológico (tratamiento dirigido) o cualquier tratamiento experimental para CPRCm, recibidos con anterioridad.
    5. Radioterapia de las lesiones óseas o cirugía traumatológica de las fracturas patológicas. Cualquier tipo de intervención quirúrgica mayor en los 30 días previos a la administración del producto del ensayo.
    6. Dosis suprafisiológicas de corticoesteroides orales, definidas como >10 mg de equivalentes de prednisona, al día.
    7. Sospecha clínica o diagnóstico confirmado de metástasis cerebrales.
    8. Metástasis viscerales.
    9. Reacciones de hipersensibilidad conocidas a algún excipiente de la medicación del ensayo.
    10. Antecedentes de reacciones alérgicas al tratamiento con cualquier otro anticuerpo monoclonal.
    11. Hipertensión no controlada definida como presión arterial sistólica ?160 mmHg o presión arterial diastólica ? 100 mmHg medida tras reposo de al menos 5 minutos.
    12. Tratamiento crónico con ácido acetilsalicílico (AAS) en dosis >100 mg diariamente.
    13. Trastornos hemorrágicos o antecedentes de episodios de tromboembolia (los antecedentes de tromboflebitis superficial no son un criterio de exclusión).
    14. Tratamiento con trombolíticos o anticoagulantes orales o parenterales en los 10 días previos al tratamiento del estudio.
    15. Vasculopatía o ulceración periférica graves, angina de pecho inestable o infarto de miocardio en los 6 meses anteriores al inicio del tratamiento del estudio, electrocardiograma (ECG) con anomalías clínicamente relevantes en el momento de la selección.
    16. Alcoholismo o toxicomanía conocidos.
    17. Participación en otro ensayo clínico en los 30 días anteriores al inicio del tratamiento del estudio.
    18. Demencia, alteración del estado mental o cualquier problema psiquiátrico que impida comprender o conceder el consentimiento informado.
    19. Infección activa o crónica por el virus de la hepatitis B o C o por el virus de la inmunodeficiencia humana (VIH).
    20. Incapacidad legal o capacidad legal limitada.
    21. Cualquier otra enfermedad importante que, según el criterio del investigador, pudiera alterar la tolerancia del sujeto al tratamiento del estudio;
    22. Otra neoplasia, si el tratamiento no se ha completado en los 2 años previos al inicio del tratamiento del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the trial is PFS defined as the time from the date of randomization until the first documented sign of objective radiographic disease progression or death from any cause.
    Objective radiographic disease progression is defined as one of the
    following conditions:
    - Bone lesion progression (appearance of 2 or more new bone lesions compared to baseline) assessed with bone scintigraphy, which should be confirmed by bone scintigraphy 6 weeks later if there are no symptoms. Assessments based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 modified according to the Prostate Cancer Working Group 2 (PCWG-2).
    - Soft-tissue lesion progression according to RECIST 1.0 assessed with CT scans.
    - Presence of skeletal events defined as cord compression or fracture documented via a scheduled or an unscheduled radiographic assessment triggered by increasing pain (needing opioids or radiation) or other signs and/or symptoms at Investigator discretion.
    El criterio de valoración principal del estudio es la SLP, definida como el tiempo transcurrido desde la fecha de aleatorización hasta la fecha de documentación del primer signo objetivo de progresión radiológica de la enfermedad o muerte por cualquier causa.
    La progresión objetiva de la enfermedad radiológica se define como una de las siguientes situaciones:
    ? Progresión de las lesiones óseas (aparición de 2 o más lesiones óseas nuevas, comparado con el período basal), evaluada mediante gammagrafía ósea y que debe confirmarse mediante otra gammagrafía ósea 6 semanas más tarde si los sujetos se mantienen asintomáticos o con sintomatología leve. Evaluaciones con arreglo a los criterios de respuesta en los tumores sólidos (RECIST) versión 1.0 modificados por el Grupo de trabajo 2 sobre el cáncer de próstata (PCWG2).
    ? Progresión de una lesión de partes blandas según los criterios RECIST 1.0 modificados según el PCWG-2, evaluada mediante TAC.
    ? Presencia de episodios esqueléticos, definidos como compresión medular o fractura documentada mediante una evaluación radiológica programada o no programada, motivada por aumento de dolor (que necesita opioides o radiación) u otros signos o síntomas según el criterio del investigador.
    E.5.1.1Timepoint(s) of evaluation of this end point
    last subject
    randomized + 4 months
    Último paciente aleatorizado + 4 meses
    E.5.2Secondary end point(s)
    - To further evaluate the efficacy of EMD 525797
    - To further characterize the safety profile of EMD 525797
    - To further evaluate the pharmacokinetic (PK) profile of
    EMD 525797
    ? Profundizar en la evaluación de la eficacia de EMD 525797
    ? Definir mejor el perfil de seguridad de EMD 525797
    ? Definir mejor el perfil farmacocinético (FC) de EMD 525797
    E.5.2.1Timepoint(s) of evaluation of this end point
    last subject
    randomized + 4 months
    Último paciente aleatorizado + 4 meses
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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. 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    Se permite cambio para el grupo placebo tras las progresión
    Cross over for placebo group allowed after progression.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Russian Federation
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 cut-off date for analysis of the primary endpoint will be defined as the time:
    - when the planned number of events have been reported (i.e., 162 subjects died or progressed per PFS definition).
    (for more details see section 5.7 in the clinical study protocol).
    La fecha límite del análisis del criterio de valoración principal se definirá por el momento en el que se haya notificado el número previsto de episodios (es decir, 162 sujetos fallecidos o con progresión de la enfermedad según la definición de SLP).
    Para mas detalles ver sección 5.7 del protocolo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    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: 216
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 108
    F.4.2.2In the whole clinical trial 216
    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)
    Safety Follow-up Visit
    Survival and Disease Progression Follow-up
    for details see protocol section synopsis page 21/118 and section 5.1.1 page 41/118.
    Visita de seguimiento de seguridad y seguimiento de la supervivencia y progresión de la enfermedad. Para detalles ver el protocolo, sinposis página 21/118 y sección 5.1.1 página 41/118.
    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 Decision2012-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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