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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   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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    Summary
    EudraCT Number:2014-005070-11
    Sponsor's Protocol Code Number:M13-694
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2015-04-27
    Trial 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 number2014-005070-11
    A.3Full title of the trial
    A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP inhibitor) in Subjects with Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
    Estudio de fase 3, controlado con placebo, de carboplatino/paclitaxel con o sin tratamiento concomitante y seguidamente de mantenimiento de veliparib (un inhibidor de la PARP) en pacientes con carcinoma epitelial seroso de ovario, tubárico o peritoneal primario de alto grado en estadio III o IV no tratado previamente.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Veliparib in combination with carboplatin and paclitaxel and as continuation maintenance therapy in subjects with newly diagnosed, untreated Stage III or IV high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer
    Veliparib en combinación con carboplatino y paclitaxel como terapia de mantenimiento en pacientes con carcinoma epitelial seroso de ovario, tubárico o peritoneal primario de alto grado en estadio III o IV no tratado previamente.
    A.4.1Sponsor's protocol code numberM13-694
    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 AddressAbbott House, Vanwall Business Park, Vanwall
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34901200103
    B.5.5Fax number+441628644330
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/830
    D.3 Description of the IMP
    D.3.1Product nameVeliparib 50 mg
    D.3.2Product code ABT-888
    D.3.4Pharmaceutical form Capsule
    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.3.8INN - Proposed INNVeliparib
    D.3.9.1CAS number 912444-00-9
    D.3.9.2Current sponsor codeABT-888
    D.3.9.3Other descriptive nameVELIPARIB
    D.3.9.4EV Substance CodeSUB32392
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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.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 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.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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/10/830
    D.3 Description of the IMP
    D.3.1Product nameVeliparib 100 mg
    D.3.2Product code ABT-888
    D.3.4Pharmaceutical form Capsule
    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.3.8INN - Proposed INNVeliparib
    D.3.9.1CAS number 912444-00-9
    D.3.9.2Current sponsor codeABT-888
    D.3.9.3Other descriptive nameVELIPARIB
    D.3.9.4EV Substance CodeSUB32392
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Newly diagnosed, untreated Stage III or IV high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer
    Carcinoma epitelial seroso de ovario, tubárico o peritoneal primario de alto grado en estadio III o IV no tratado previamente.
    E.1.1.1Medical condition in easily understood language
    Ovarian cancer or ovarian neoplasm
    Cáncer de ovario o neoplasia de ovario
    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
    The primary objective of the study is to evaluate whether progression-free survival (PFS) is prolonged when veliparib is added to standard platinum-based chemotherapy and then continued as maintenance in both the whole subject population, as well as a more selective cohort of subjects with BRCA-deficient tumors
    El objetivo principal del estudio es evaluar si la SSP(Supervivencia sin progresión) se prolonga cuando se añade veliparib a la quimioterapia convencional a base de platino (carboplatino/paclitaxel) y se continúa después como tratamiento de mantenimiento, en la población completa de pacientes, así como en una cohorte más selectiva de pacientes con tumores deficientes en BRCA
    E.2.2Secondary objectives of the trial
    The primary objective of the study is to evaluate whether progression-free survival (PFS) is prolonged when veliparib is added to standard platinum-based chemotherapy and then continued as maintenance in both the whole subject population, as well as a more selective cohort of subjects with BRCA-deficient tumors
    El objetivo principal del estudio es evaluar si la SSP(Supervivencia sin progresión) se prolonga cuando se añade veliparib a la quimioterapia convencional a base de platino (carboplatino/paclitaxel) y se continúa después como tratamiento de mantenimiento, en la población completa de pacientes, así como en una cohorte más selectiva de pacientes con tumores deficientes en BRCA
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenetic and pharmacodynamic substudy - optional blood and tissue tests respectively
    Subestudios farmacogético y farmacodinámico, pruebas opcionales de sangre y tejido respectivamente
    E.3Principal inclusion criteria
    "Subject must be ? 18 years of age
    High-grade serous adenocarcinoma
    Willing to undergo testing for gBRCA
    Eastern Cooperative Oncology Group performance status of 0, 1, or 2"
    ?Las pacientes deben tener ? 18 años de edad y adenocarcinoma seroso de alto grado Deberán aceptar que se le realice una prueba de gBRCA Estado funcional del ECOG (Eastern Cooperative Oncology Group) de 0, 1 o 2?
    E.4Principal exclusion criteria
    "Following histologic cell types are ineligible: endometrioid adenocarcinoma, carcinosarcoma, undifferentiated carcinoma, mixed epithelial adenocarcinoma, adenocarcinoma not otherwise specified, mucinous adenocarcinoma, clear cell adenocarcinoma, low-grade serous adenocarcinoma, or malignant Brenner's tumor.
    Synchronous primary endometrial cancer, or a past history of endometrial cancer.
    Prior radiotherapy to any portion of the abdominal cavity or pelvis
    Clinically significant uncontrolled condition(s), including but not limited to: Bowel obstruction or gastric outlet obstruction.
    History or evidence upon physical examination of central nervous system (CNS) disease.
    "
    No son elegibles los siguientes tipos celulares histológicos: adenocarcinoma endometrioide, carcinosarcoma, carcinoma indeferenciado, adenocarcinoma epitelial mixto, adenocarcinoma sin especificar, adenocarcinoma mucinoso, adenocarcinoma de células claras, adenocarcinoma seroso de bajo grado, carcinoma de células transicionales o tumor de Brenner maligno.
    Cáncer endometrial primario sincrónico o antecedentes de cáncer de endometrio
    Radioterapia previa en alguna parte de la cavidad abdominal o de la pelvis.
    Enfermedad no controlada clínicamente relevante, incluyendo pero no limitado a: obstrucción intestinal o pilórica.
    Historial o evidencia de trastornos del sistema nervioso central (SNC),
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival in both the whole subject population, as well as a more selective cohort of subjects with BRCA-deficient tumors
    Supervivencia sin progresión en la población completa de pacientes, así como una cohorte más selectiva de pacientes con tumores deficientes en BRCA
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS will be defined as the number of days from the date that the subject was randomized to the date the subject experiences an event of disease progression, according to RECIST criteria version 1.1 (as determined by the Investigator) or to the date of death (all causes of mortality) if disease progression is not reached
    La supervivencia sin progresión (SSP) se define como el número de días desde que el paciente es aleatorizado hasta la fecha en la que la paciente experimenta progresión de la enfermedad, de acuerdo a los criterios RECIST versión 1.1 (determinados por el investigador) o hasta la fecha de muerte (todas las causas de mortalidad) si la progresión de la enfermedad no se alcanza.
    E.5.2Secondary end point(s)
    PFS with veliparib in combination with chemotherapy versus chemotherapy alone, overall survival (OS), safety, and Patient Reported Outcomes
    SSP con veliparib en combinación con quimioterapia frente a quimioterapia sola, supervivencia global (SG), seguridad y Cuestionarios de Resultados comunicados por los pacientes (RCP).
    E.5.2.1Timepoint(s) of evaluation of this end point
    As per protocol
    Como descrito en el protocolo
    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) 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 No
    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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Argentina
    Australia
    Israel
    Japan
    Korea, Democratic People's Republic of
    New Zealand
    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
    LVLS
    Ultima visista del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 1100
    F.1.3Elderly (>=65 years) No
    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 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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 176
    F.4.2.2In the whole clinical trial 1100
    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)
    As per Protocol
    Como descrito en el protocolo
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Gynocological Oncology Group (GOG)
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-18
    P. End of Trial
    P.End of Trial StatusRestarted
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