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    The EU Clinical Trials Register currently displays   35896   clinical trials with a EudraCT protocol, of which   5892   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-003493-19
    Sponsor's Protocol Code Number:BO17929
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-01-16
    Trial results View 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 ConcernedSpain - AEMPS
    A.2EudraCT number2005-003493-19
    A.3Full title of the trial
    Estudio de fase II exploratorio, multicéntrico, con un solo grupo de tratamiento para evaluar la eficacia y seguridad de la combinación de Omnitarg™ (pertuzumab) y Herceptin® (trastuzumab) en pacientes con cáncer de mama metastático HER2-positivo.

    A phase II exploratory, single arm, multicenter study to evaluate the efficacy and safety of the combination of Omnitarg™ (pertuzumab) and Herceptin® (trastuzumab) in patients with HER2-positive metastatic breast cancer.
    A.4.1Sponsor's protocol code numberBO17929
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameOmnitarg™
    D.3.2Product code RO4368451
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPertuzumab
    D.3.9.2Current sponsor codeRO4368451
    D.3.9.3Other descriptive namerhuMAb 2C4
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number175 mg/7 ml
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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.3.11.13.1Other medicinal product typeAnticuerpo monoclonal humanizado
    D.IMP: 2
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Herceptin®
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited, UK
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameHerceptin®
    D.3.2Product code RO45-2317
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTrastuzumab
    D.3.9.2Current sponsor codeRO45-2317
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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.3.11.13.1Other medicinal product typeAnticuerpo monoclonal humanizado
    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
    Cáncer de mama metastático.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10027475
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Realizar una evaluación preliminar de la eficacia de Omnitarg™ en combinación con Herceptin® en pacientes que han manifestado progresión de la enfermedad durante un tratamiento previo basado en Herceptin®, lo que se determinará por el índice de respuesta objetiva y/o el índice de respuesta de beneficio clínico (número total de respuestas y de pacientes con enfermedad estable durante > 6 meses).
    E.2.2Secondary objectives of the trial
    - Evaluar el perfil de seguridad de la combinación de Omnitarg™ y Herceptin®.
    - Determinar la duración de la respuesta, el tiempo hasta la respuesta, el tiempo hasta la progresión de la enfermedad y la supervivencia libre de progresión.
    - Evaluar los biomarcadores que pueden estar asociados con el beneficio clínico proporcionado por Omnitarg™ en combinación con Herceptin ®
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Cáncer de mama confirmado histológicamente.
    2. Tumores HER2-positivo. El estado de HER2 se debe reconfirmar en un laboratorio central antes de la inclusión en el estudio.
    3. Disponibilidad de una muestra de tejido tumoral FFPE del tumor primario para las pruebas de selección (determinación del estado de HER2) y la evaluación de biomarcadores.
    4. Pacientes con cáncer de mama metastático que han manifestado progresión durante el último tratamiento para la enfermedad metastática que estaba basado en Herceptin®.
    5. Pacientes tratadas con ≤ 2 regímenes de quimioterapia antes de la inclusión en el estudio.
    6. La última dosis de Herceptin® se debe haber administrado ≤ 6 semanas antes del día 1 del estudio.
    7. Las pacientes deben presentar, como mínimo, una lesión medible, de acuerdo con los criterios RECIST. Las lesiones medibles localizadas en áreas irradiadas previamente deben revelar signos claros de progresión de la enfermedad (aumento del tamaño ≥ 50% o aparición de lesiones nuevas)
    8. FEVI ≥ 55 % o ≥ LSN del rango local, valorada con ecocardiografía o MUGA.
    9. Estado funcional ECOG ≤ 2.
    10. Edad ≥ 18 años
    E.4Principal exclusion criteria
    1. Tratamiento previo con cualquier agente biológico diana distinto de Herceptin®, por ejemplo, cetuximab, bevacizumab, gefitinib o con una vacuna anticancerosa.
    2. Exposición previa a las siguientes dosis acumuladas de antraciclinas: doxorubicina o doxorubicina liposomal > 360 mg/m2, epirubicina > 720 mg/m2, mitoxantrona > 120 mg/m2, idarubicina > 90 mg/m2
    3. Reducciones asintomáticas confirmadas de la FEVI de ≥ 15% con respecto al valor basal y/o por debajo del valor absoluto del 50% durante el tratamiento con Herceptin®.
    4. Pacientes con antecedentes confirmados de acontecimientos adversos cardíacos, que de acuerdo con el criterio del investigador, estaban relacionados con el tratamiento con Herceptin®.
    5. Antecedentes de insuficiencia cardíaca congestiva (de cualquier grado NYHA), angina de pecho inestable, evidencia de infarto transmural en ECG, hipertensión no controlada (sistólica > 180 mm Hg y/o diastólica > 100 mm Hg), o valvulopatía hemodinámicamente significativa.
    6. Otras neoplasias en los 5 últimos años, excepto carcinoma in situ de cervix o carcinoma basocelular.
    7. Recuento absoluto de neutrófilos (RAN) < 1,5 x 109/l, recuento de plaquetas < 100 x 109/l o concentración de Hb < 10 g/dl.
    8. Alteraciones de la función hepática: bilirrubina sérica [total] > 1,5 x LSN, AST, ALT > 2,5 x LSN, (> 5 x LSN en las pacientes con metástasis hepáticas).
    9. Concentración de creatinina sérica > 2 x LSN
    10. Antecedentes o evidencia clínica de metástasis cerebrales.
    11. Enfermedad sistémica severa no controlada (p. ej. hipertensión, trastornos cardiovasculares, pulmonares, metabólicos, así como heridas, úlceras o fracturas óseas que sean clínicamente significativos).
    12. Pacientes con disnea en reposo severa que precisen oxigenoterapia suplementaria debido a complicaciones de la enfermedad neoplásica avanzada.
    13. Prueba de embarazo positiva en las mujeres en edad fértil
    14. Pacientes en edad fértil que no estén dispuestas a utilizar métodos anticonceptivos eficaces.
    15. Mujeres embarazadas o en período de lactancia.

    E.5 End points
    E.5.1Primary end point(s)
    Respuesta objetiva: En la evaluación del tumor, se considerará que se ha alcanzado respuesta objetiva, de acuerdo con los criterios RECIST, si se ha documentado y confirmado la respuesta completa (RC) o la respuesta parcial (RP).

    Respuesta de beneficio clínico: Incluye las pacientes que han cumplido los criterios de respuesta objetiva en cualquier momento y ésta ha sido de cualquier duración (como mínimo 4 semanas) y las pacientes cuya mejor respuesta sea enfermedad estable (definida de acuerdo con los criterios RECIST) durante un mínimo de 6 meses (u 8 ciclos de tratamiento).

    Ambas están basadas en las evaluaciones de las lesiones diana y no diana, de acuerdo con los criterios RECIST, para asegurar el estado de la mejor respuesta global de cada paciente al final del estudio.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Evaluar los biomarcadores que pueden estar asociados con el beneficio clínico
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-01-16. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 46
    F.4.2.2In the whole clinical trial 62
    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 Decision2006-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-01
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