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    Summary
    EudraCT Number:2017-003669-87
    Sponsor's Protocol Code Number:M14-064
    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:2018-03-06
    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 number2017-003669-87
    A.3Full title of the trial
    Phase 2 Study Comparing Efficacy and Safety of ABT-165 and FOLFIRI vs Bevacizumab and FOLFIRI in Metastatic Colorectal Cancer Previously Treated with Fluoropyrimidine/Oxaliplatin and Bevacizumab
    Estudio de fase 2 para comparar la eficacia y la seguridad de ABT-165 más FOLFIRI frente a bevacizumab más FOLFIRI en el cáncer colorrectal metastásico tratado previamente con fluoropirimidina/oxaliplatino y bevacizumab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ph2 study of chemotherapy plus ABT-165 compared to chemotherapy plus bevacizumab in people with metastatic colorectal (bowel) cancer
    Estudio de fase 2 de quimiterapia más ABT-165 en comparación con quimioterapia más bevacizumab en personas con cancer colorrectal (intestino) metastásico.
    A.4.1Sponsor's protocol code numberM14-064
    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 SponsorAbbvie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number34901200103
    B.5.6E-mailabbvie_reec@abbvie.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 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.3.2Product code ABT-165
    D.3.4Pharmaceutical form Lyophilisate 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 INNABT-165
    D.3.9.3Other descriptive nameABT-165
    D.3.9.4EV Substance CodeSUB185761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country 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 nameBevacizumab
    D.3.4Pharmaceutical form 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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 adenocarcinoma of the colon or rectum previously treated with a regimen containing fluoropyrimidine/oxaliplastin and bevacizumab
    adenocarcinoma metastásico del colon o recto previamente tratado con un régimen de fluoropirimidina/oxaliplastino y bevacizumab
    E.1.1.1Medical condition in easily understood language
    Colorectal (bowel) cancer that has been treated with chemotherapy and bevacizumab and has progressed.
    Cáncer colorrectal (intestino) que se ha tratado con quimioterapia y bevacizumab y ha progresado.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To estimate the progression-free survival (PFS) of ABT-165 plus irinotecan, fluorouracil and leucovorin chemotherapy regimen (FOLFIRI) compared to bevacizumab plus FOLFIRI, as assessed by blinded independent central review, in subjects with previously treated mCRC who have received a regimen containing fluoropyrimidine, oxaliplatin, and bevacizumab.
    Para estimar la supervivencia libre de progresión (SLP) de ABT-165 más irinotecan, quimioterapia con fluoracilo y leucovirina (FOLFIRI) en comparación con bevacizumab más FOLFIRI, como testado por revisión centralizada independiente ciega, en sujetos con cancer colorrectal metastásico previamente tratado que han recibido tratamiento con fluoropirimidina, oxaliplatino y bevacizumab
    E.2.2Secondary objectives of the trial
    To assess overall survial (OS), objective response rate (ORR), safety, and tolerability of ABT-165 plus FOLFIRI compared to bevacizumab plus FOLFIRI.
    Para testar la supervivencia global (SG), el ratio de respuesta objetiva, seguridad y tolerabilidad del ABT-165 más FOLFIRI frente a bevacizumab más FOLFIRI
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnosis of histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
    - At least 1 unresectable lesion on a computed tomography (CT) scan that is measurable as defined by RECIST, Version 1.1.
    - Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
    - Progression following treatment withfluoropyrimidine/oxaliplatin/bevacizumab-regimen in the metastatic setting
    - Adequate hematologic, renal and hepatic function
    -Diagnóstico de adenocarcinoma de colon o recto metastásico con confirmación citológica o histológica
    -Al menos 1 lesión irresecable en tomografía cumputarizada (TC) medible según RECIST versión 1.1
    -Puntuación ECOG (Grupo de Oncología Cooperativo del Este) de 0 a 1
    -Tratamiento con fluoropirimidina / oxaliplatino /bevacizumab en progresión para metastásico
    E.4Principal exclusion criteria
    - Any prior therapy with irinotecan
    - Unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) ≥ Grade 2
    - Clinically significant condition(s) that might put the subject at higher risk for anti-angiogenic therapy
    - Prior history of clinically significant: pulmonary hypertension, uncontrolled systemic hypertension or hypertensive crisis, symptomatic heart failure (Heart Association class III – IV), cardiomyopathy, myocardial infarction, unstable/severe angina pectoris, cardiac arrhythmia, coronary/peripheral artery bypass graft, aneurysm or aneurysm repair, angioplasty, cerebrovascular accident or transient ischemic attack within 1 year of randomization.
    - History of any of the following during first-line therapy with a bevacizumab-containing regimen: arterial thrombotic/thromboembolic event, bowel perforation, Grade 4 hypertension, Grade 3 proteinuria or Grade 3 – 4 bleeding event.
    Cualquier terapia previa con irinotecan
    Toxicidad clinicamente significativa no resuelta de la anterior terapia anti cáncer, definida como CTCAE (Criterios de terminología común para Eventos Adversos) ≥ Grado 2
    -Condición clinicamente significativa que pueda poner en alto riesgo al sujeto para una terapia anti angiogénica
    -Historia previa clinicamente significativa: hipertensión pulmonar, hipertensión sistémica no controlada o crisis hipertensivas, insuficiencia cardíaca sintomática (Asociación del Corazón clase III – IV), cardiomiopatía, infarto del miocardio, angina pectoris severa o instable, arritmia cardíaca, bypass coronárico o de arteria periférica, aneurisma o reparación de aneusrisma, angioplastica, accidente cerebrovascular o isquemia transitoria en un año de la aleatorización.
    -Historia de cualquiera de estas terapias en primera línea con tratamiento que incluye bevacizumab: evento trombólico o tromboembólico arterial, perforación intestinal, hipertensión grado 4, proteinuria grado 3 o sangrado grado 3-4.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS)
    Supervivencia libre de progresión
    E.5.1.1Timepoint(s) of evaluation of this end point
    From the time of randomization to the first occurrence of radiographic progression during the treatment or follow-up period
    Desde la aleatorización a la primera prueba radiográfica de progresión durante el tratamiento o en el periodo de seguimiento
    E.5.2Secondary end point(s)
    overall suvival (OS), objective response rate (ORR) and Safety
    Supervivencia global, ratio de respuesta objetiva y seguridad
    E.5.2.1Timepoint(s) of evaluation of this end point
    OS: from randomization until death from any cause during the treatment or follow-up period
    ORR: up to 30 days after a 24-month treatment period
    Safety: up to 90 days after a 24-month treatment period
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Canada
    Korea, Republic of
    Taiwan
    United States
    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-study is defined as the date of last subject's last survival follow-up contact. The sponsor may also end the study at any time.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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 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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 100
    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)
    The plan will be discussed between the Investigator and subject. There will be follow-up contact as stated in the informed consent and also arrangement for continuing care off study.
    El plan de tratamiento será hablado entre el investigador y el sujeto. Habrá contacto de seguimiento tal y como informa el consentimiento y también acuerdos para continuar los cuidados del estudio
    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 Decision2018-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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