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    Summary
    EudraCT Number:2011-001526-19
    Sponsor's Protocol Code Number:BO27798
    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:2011-10-13
    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 number2011-001526-19
    A.3Full title of the trial
    A randomized, open-label, multicenter Phase IIIb study comparing two trastuzumab dosing regimens, each in combination with cisplatin/ capecitabine chemotherapy, as first-line therapy in patients with HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.
    Estudio de fase IIIb multicéntrico, abierto, randomizado, para comparar dos regímenes de administración de trastuzumab, cada uno en combinación con quimioterapia con cisplatino/capecitabina para tratamiento de primera línea de pacientes con adenocarcinoma gástrico o de la unión gastroesofágica metastásico HER-2 positivo que no han recibido previamente tratamiento para la enfermedad metastásica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A global and multicenter Phase IIIb study comparing two trastuzumab dosing regimens, each in combination with chemotherapy (cisplatin/capecitabine), as therapy in patients with HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.
    Estudio de fase IIIb multicéntrico, global para comparar dos regímenes de administración de trastuzumab, cada uno en combinación con quimioterapia (cisplatino/capecitabina) para tratamiento de adenocarcinoma gástrico o de la unión gastroesofágica metastásico HER-2 positivo en pacientes que no han recibido previamente tratamiento para la enfermedad metastásica.
    A.4.1Sponsor's protocol code numberBO27798
    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 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 supportF.Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone numbernananana
    B.5.5Fax numbernananana
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    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 Herceptin®
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 Powder for concentrate for 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.3.8INN - Proposed INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.9.2Current sponsor codeRO0452317
    D.3.9.3Other descriptive namerhuMAb HER2, Anti-HER
    D.3.9.4EV Substance CodeSUB12612MIG
    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) 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 Yes
    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 typehumanised IgG1 monoclonal antibody Anticuerpo monoclonal humanizado IgG1
    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 HER2-positive adenocarcinoma of the stomach or gastro-esophageal junction.
    Adenocarcinoma gástrico o de la unión gastroesofágica metastásico HER2 positivo
    E.1.1.1Medical condition in easily understood language
    Metastatic HER2-positive adenocarcinoma of the stomach or gastro-esophageal junction.
    Adenocarcinoma gástrico o de la unión gastroesofágica metastásico HER2 positivo
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10063916
    E.1.2Term Metastatic gastric 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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10071114
    E.1.2Term Metastatic gastric adenocarcinoma
    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 compare the duration of overall survival in patients who are randomized at enrollment to treatment with one of two trastuzumab dosing regimens (loading dose of 8mg/kg) followed by either 6mg/kg or 10mg/kg maintenance doses given every 3 weeks, plus cisplatin and capecitabine.
    Comparar la duración de la supervivencia global (SG) en los pacientes randomizados tras su inclusión en el estudio para recibir tratamiento con uno de los dos regímenes de administración de trastuzumab (dosis inicial de 8 mg/kg, seguida de dosis de mantenimiento de 6 mg/kg o 10 mg/kg administradas cada 3 semanas), en combinación con cisplatino y capecitabina.
    E.2.2Secondary objectives of the trial
    ? To compare the duration of overall survival (OS) in patients on the two trastuzumab treatment arms who are found to have trastuzumab Cmin values < 12 ?g/mL on Cycle 1 Day 21.
    ? To assess trastuzumab concentrations during treatment Cycle 1 and trastuzumab Cmin(Day 21) values in additional treatment cycles through Cycle 11 (ie, pre-dose concentration before Cycle 12) or until disease progression (whatever occurs first) for the two dosing regimens.
    ? To evaluate the safety and tolerability of trastuzumab for the two dosing regimens.
    ? To compare the duration of progression-free survival (PFS) and the overall objective response rate (ORR) in patients on the two trastuzumab treatment arms who are found to have trastuzumab Cmin values < 12 ?g/mL on treatment Cycle 1 Day 21.
    ?Comparar la duración de la SG en los pacientes de los dos grupos de tratamiento con trastuzumab en los que se observen valores de la Cmin de trastuzumab < 12 µg/ml el día 21 del ciclo 1.
    ?Evaluar las concentraciones de trastuzumab durante el primer ciclo de tratamiento y los valores de la Cmin de trastuzumab (día 21) en los ciclos de tratamiento adicionales, hasta el ciclo 11 (es decir, la concentración previa a la administración de la dosis alcanzada antes del ciclo 12) o hasta que se manifieste progresión de la enfermedad (dependiendo de lo que ocurra antes) en los dos regímenes de tratamiento.
    ?Evaluar la seguridad y la tolerancia de trastuzumab en los dos regímenes de administración.
    Comparar la duración de la SLP y el IRO en los pacientes de los dos grupos de tratamiento con trastuzumab en los que se observen valores de la Cmin de trastuzumab < 12 µg/ml el día 21 del ciclo 1 de tratamiento.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Evaluation of the pharmacokinetics of trastuzumab administered every three weeks at two different maintenance dose levels to patients with metastatic HER2-positive gastric or gastro-esophageal junction adenocarcinoma. Protocol BO27798PK version A dated 23 June 2011. The objectives are
    ? To characterize the serum trastuzumab concentration-vs-time (C-vs-T) profiles in the study population following the initial loading dose (8 mg/kg) at Cycle 1, and the maintenance doses (6 mg/kg or 10 mg/kg q3W) at Cycles 2 and 4.
    ? To evaluate the accumulation of peak and trough serum trastuzumab concentrations following selected sequential doses given every three weeks, up to the projected steady-state (Cycles 1, 2, 3, 4, 5,
    7, 9, and 11).
    ? To describe the pharmacokinetic (PK) of trastuzumab in patients with metastatic gastric/GEJ cancer and compare to previous observations in
    patients with metastatic breast cancer and gastric cancer.
    ? To support development and refinement of an integrated population-based model for the PK disposition of trastuzumab in cancer patients, using data from multiple dosing regimens and disease types.
    Evaluación de la farmacocinética de trastuzumab administrado cada tres semanas, utilizando dos dosis de mantenimiento diferentes, a pacientes con adenocarcinoma gástrico o de la unión gastroesofágica metastásico HER-2 positivo.
    E.3Principal inclusion criteria
    1. Male or female. Age ? 18 years.

    2. Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with metastatic disease documented to involve at least two organs (at least lung or liver or both)

    3. Measurable disease according to RECIST 1.1.

    4. HER2 positive (defined as either IHC3+ or IHC2+/ISH+, with ISH positivity defined as a ratio of >=2.0 of HER2 gene copy number/number of signals for CEP 17) primary or metastatic tumor, as assessed by central laboratory

    5. CCR >=45 ml/min

    6. ECOG PS _2
    1.Varones o mujeres de ? 18 años de edad.
    2.Adenocarcinoma gástrico o de la unión gastroesofágica confirmado histológicamente, con enfermedad metastásica documentada que afecta a un mínimo de dos órganos (incluyendo, al menos, hígado o pulmón o ambos).
    3.Enfermedad medible, de acuerdo con los Criterios de Evaluación de la Respuesta en Tumores Sólidos (RECIST 1.1),
    4.Tumor primario o metastásico HER2 positivo (que se define como IHC 3+ o IHC 2+/ISH+; donde la positividad en ISH se define como una relación del número de copias del gen HER2 al número de señales en CEP17 de ? 2,0), de acuerdo con la evaluación realizada en el laboratorio central.
    5.Aclaramiento de creatinina (CrCl) ? 45 ml/min.
    6.Estado funcional ECOG 2.
    E.4Principal exclusion criteria
    1. Previous chemotherapy for locally advanced or metastatic disease

    2. Prior gastrectomy

    3. Prior therapy with an anti-HER2 agent and/or platinum-based chemotherapeutic agent

    4. Residual relevant toxicity resulting from previous therapy


    5. History of documented congestive heart failure; angina pectoris requiring medication; electrocardiogram (ECG) evidence of trans-mural myocardial infarction; poorly controlled hypertension (systolic blood pressure (BP) > 180 mmHg or diastolic BP>100 mm Hg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias

    6. Baseline LVEF< 50%, documented by echocardiography, MUGA scan, or cardiac MRI.
    1.Quimioterapia previa para la enfermedad localmente avanzada o metastásica
    2.Gastrectomía previa
    3.Tratamiento previo con un agente anti-HER2 y/o un agente de quimioterapia derivado de platino.
    4.Toxicidad residual
    5.Antecedentes de insuficiencia cardíaca congestiva documentada; angina de pecho que requiera medicación; evidencia de infarto de miocardio transmural en el electrocardiograma (ECG); hipertensión mal controlada (presión arterial [PA] sistólica > 180 mm Hg o diastólica > 100 mm Hg); cardiopatía valvular clínicamente significativa o arritmias de alto riesgo no controlables.
    6.FEVI basal < 50% (documentada en ecocardiografía, MUGA o RM cardíaca).
    E.5 End points
    E.5.1Primary end point(s)
    The study primary endpoint will be OS duration in all randomized patients.
    La variable principal de este estudio será la duración de la supervivencia global (SG) en todos los pacientes randomizados.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This is event driven, when 379 deaths have occurred.
    Se llevará esta evaluación cuando hayan ocurrido 379 muertes
    E.5.2Secondary end point(s)
    The secondary endpoints will be OS in patients with Cycle 1 Cmin <12 ug/ml, Pharmacokinetic analyses , safety and tolerability in the two dosing regimens; duration of progression-free survival (PFS) and the overall objective response rate (ORR) in patients who are found to have trastuzumab Cmin values < 12 ?g/mL on treatment Cycle 1 Day 21.
    Variables secundarias: duración de la SG en los pacientes en los que se observen valores de la Cmin de trastuzumab < 12 µg/ml el día 21 del ciclo 1 de tratamiento tras la administración de la dosis inicial de 8 mg/kg; supervivencia libre de progresión e índice de respuesta objetiva global (basándose en los criterios RECIST v1.1) en todos los pacientes y en el subgrupo de pacientes con Cmin < 12 µg/ml en el ciclo 1.
    E.5.2.1Timepoint(s) of evaluation of this end point
    This is event driven, when 379 deaths have occurred.
    Esto ocurrirá cuando hayan ocurrido 379 muertes
    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 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
    overall survival (OS); progression-free survival (PFS) and the overall objective response rate (ORR)
    Supervivencia Global (SG); supervivencia libre de progresión (SLP) e el índice de respuesta objetiva global (IRO)
    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) Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    Estándar de tratamiento (quimioterapia cisplatino/capecitabina)
    Standard of care (cisplatin/capecitabine chemotherapy)
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Australia
    Bosnia and Herzegovina
    Brazil
    Canada
    Chile
    China
    Czech Republic
    Germany
    Hungary
    India
    Italy
    Korea, Republic of
    Mexico
    New Zealand
    Panama
    Peru
    Philippines
    Poland
    Portugal
    Russian Federation
    Serbia
    South Africa
    Spain
    Turkey
    Ukraine
    United Kingdom
    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 end of the study will be when the targeted number of events for the final analysis of OS (379/400) is reached and the last patient has completed 6 months of cardiac safety follow-up thereafter, or when the study is terminated by the Sponsor, whichever occurs first.
    Patients still receiving trastuzumab at the time of study end and who do not have PD will be allowed to continue trastuzumab until progression of disease under a separate extension protocol.
    El estudio terminará cuando se haya alcanzado el número de acontecimientos pretendido para el análisis final de la SG (379/400) y el último paciente haya completado posteriormente la fase de seguimiento de la seguridad cardíaca de 6 meses o cuando el promotor decida terminar el estudio, dependiendo de lo que ocurra antes.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months2
    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: 263
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 142
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 130
    F.4.2.2In the whole clinical trial 406
    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)
    Patients still receiving trastuzumab at the time of study end and who do not have PD will be allowed to continue trastuzumab until progression of disease under a separate extension protocol.
    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 Decision2011-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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