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    Summary
    EudraCT Number:2011-003618-18
    Sponsor's Protocol Code Number:M10-897
    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:2013-01-23
    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 number2011-003618-18
    A.3Full title of the trial
    A Randomized, Double-Blind, Phase 2, Dose-Ranging
    Study to Evaluate the Safety and Efficacy of
    Veliparib and Whole Brain Radiation Therapy Versus
    Placebo and Whole Brain Radiation Therapy in
    Subjects with Brain Metastases from Non-Small Cell
    Lung Cancer
    Estudio aleatorizado, doble ciego, en fase 2 de búsqueda de dosis para evaluar la seguridad y la eficacia de Veliparib y radioterapia cerebral total frente a placebo y radioterapia cerebral total en
    pacientes con metástasis cerebrales de cáncer de pulmón no microcítico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Whole Brain Radiation Therapy (WBRT) with Veliparib or without Veliparib in patients with Brain Metastases from Non-Small Cell Lung Cancer.
    Un estudio de radioterapia cerebral total (RCT) con Veliparib o sin Veliparib en pacientes con metástasis cerebrales en cáncer de pulmón no microcítico
    A.4.1Sponsor's protocol code numberM10-897
    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+4401628644475
    B.5.5Fax number+4401628644330
    B.5.6E-maileuclinicaltrials@abbott.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.3.1Product 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.3.9.2Current sponsor codeABT-888
    D.3.9.3Other descriptive nameABT-888
    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 No
    D.2.5.1Orphan drug designation number
    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.3.9.2Current sponsor codeABT-888
    D.3.9.3Other descriptive nameABT-888
    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
    D.8 Placebo: 2
    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
    Brain metastases from NSCLC
    Metástasis cerebrales de CPNM
    E.1.1.1Medical condition in easily understood language
    Brain metastases from Non-small cell lung cancer
    Metástasis cerebrales de cáncer de pulmón no microcítico
    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 10006128
    E.1.2Term Brain metastases
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess whether the addition of Veliparib when given during whole brain radiation therapy (WBRT) improves Overall Survival (OS) for subjects with brain metastases from Non-small Cell Lung Cancer (NSCLC).
    Evaluar si la adición de Veliparib cuando se administra durante la radioterapia celebral total (RCT) mejora la Supervivencia Global (SG) en pacientes con con metástasis cerebrales en cáncer de pulmón no microcítico
    E.2.2Secondary objectives of the trial
    To assess Safety, Response Rate of Brain Metastases at 4 months, Time to Intracranial Progression (Radiographic), and Time to Clinical Brain Metastasis Progression. Also to evaluate whether addition of twice daily oral Veliparib during WBRT delays deterioration of neurological symptoms, delays functional decline, and improves subject quality of life.
    Para evaluar la seguridad, la tasa de respuesta de las metástasis cerebrales a los 4 meses, el tiempo hasta la progresión intracraneal (radiográfica), y el tiempo hasta la progresión clínica de metástasis cerebral. También para evaluar si la adición de Veliparib por vía oral dos veces al día durante la radioterapias retrasa el deterioro de los síntomas neurológicos, retrasos en el declive funcional y mejora la calidad de sujeto de la vida.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject must be ? 18 years of age;
    Subject must have cytologically or histologically confirmed NSCLC;
    Subject must have brain metastases as demonstrated on a MRI brain scan;
    Subject must be eligible for WBRT;
    El paciente deberá tener ?18 años de edad.
    El paciente deberá tener CPNM confirmado por citología o histología.
    El paciente deberá tener metástasis cerebrales demostradas en una RM cerebral.
    Los pacientes deberán ser elegibles para tratamiento con RCT.
    E.4Principal exclusion criteria
    Subject was diagnosed with brain metastasis ?21 days prior to Treatment Day 1;
    Subject received any prior form of cranial radiation and/or neurosurgery for brain metastasis;
    Subject has a Karnofsky Performance Score (KPS) of < 70;
    Subject has a GPA Score of ? 1.0;
    Subject has significant dyspnea requiring supplemental oxygen therapy;
    Subject has liver metastases (restaging is not required for known liver metastasis);
    Subject has more than 2 sites (organ systems) of metastases from NSCLC with the exception of the following: intra-cranial sites of metastasis from NSCLC, thoracic sites of metastasis from NSCLC, and bone metastasis;
    Subject has leptomeningeal metastases or subarachnoid spread of tumor as demonstrated on a baseline MRI brain scan;
    Subject's last dose of chemotherapy or investigational therapy was ? 7 days prior to Treatment Day 1;
    Subject has unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or prior anti-cancer treatment;
    Subject has a known seizure disorder that is uncontrolled, or has seizures occurring greater than or equal to 3 times a week over the past month. Subjects presenting with symptoms of seizures from the brain metastasis are eligible however he/she should receive adequate anti-seizure medication prior to study treatment;
    Subject is pregnant or lactating;
    Subject has previously been treated with a PARP inhibitor as an investigational agent;
    Subject has clinically significant and uncontrolled major medical condition(s)
    Pacientes diagnosticados de metástasis cerebrales ? 21 días antes del día 1 de tratamiento.
    El paciente ha recibido cualquier forma previa de radioterapia craneal o neurocirugía para las metástasis cerebrales.
    El paciente tiene una puntuación del Índice del estado funcional de Karnofsky (EFK) < 70.
    El paciente tiene una puntuación de la VPG ? 1,0.
    El paciente sufre disnea importante que exige oxigenoterapia suplementaria.
    El paciente tiene metástasis hepáticas (no se precisa nueva estadificación de las metástasis hepáticas conocidas).
    El paciente tiene más de 2 focos (sistemas orgánicos) de metástasis de CPNM con las excepciones siguientes: Focos intracraneales de metástasis de CPNM; Focos torácicos de metástasis de CPNM y Metástasis óseas;
    El paciente tiene metástasis leptomeníngeas o diseminación subaracnoidea del tumor demostradas en una RM cerebral
    El paciente tiene toxicidad grave no resuelta o inestable por la administración previa de otro fármaco en investigación o tratamiento anticanceroso previo.
    El paciente sufre un trastorno convulsivo conocido no controlado, o sufre crisis que se han producido 3 ó más veces a la semana en el último mes. Los pacientes que presenten síntomas de crisis convulsiva por las metástasis cerebrales son elegibles; sin embargo, deben recibir medicación antiepiléptica adecuada antes del tratamiento del estudio
    Mujeres embarazadas o lactantes.
    El paciente ha recibido tratamiento previo con un inhibidor de PARP como farmaco en investigación
    El paciente sufre algún proceso médico de importancia clínica y no controlado.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is Overall Survival
    El criterio de valoración de la eficacia principal es la supervivencia global.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Overall Survival for a given subject will be defined as the number of days from the date the subject was randomized to the date of the subject's death
    La supervivencia global de un paciente se definirá como el número de días transcurridos desde la fecha en que se aleatorizó al paciente hasta la fecha de su muerte.
    E.5.2Secondary end point(s)
    Best Tumor Response Rate will be defined as the proportion of subjects with a complete or partial response determined by the central imaging vendor based on the bi-dimensional criteria;
    Time to Intracranial Progression (radiographic) will be defined as the number of days from the date the subject was randomized to the date the subject experienced an event of radiographic progression (intracranial) determined by the central imaging vendor;
    Time to Clinical Brain Metastasis progression will be defined as the number of days from the date of randomization to the date of earliest neurological deterioration (signs and symptoms) as determined by the Event Review Board
    La mejor tasa de respuesta tumoral se definirá como la proporción de pacientes con respuesta completa o parcial determinada por el laboratorio central de imágenes basándose en los criterios bidimensionales modificados.
    El tiempo hasta la progresión intracraneal (radiológica) se definirá como el número de días desde la fecha en que se aleatorizó al paciente hasta la fecha en la que sufrió un episodio de progresión radiológica (intracraneal) determinado por el laboratorio central de imágenes.
    El tiempo hasta la progresión clínica de las metástasis cerebrales se definirá como el número de días desde la fecha de aleatorización hasta la fecha de la progresión clínica más precoz de las metástasis cerebrales determinada de forma independiente por el Comité Independiente de revisión de datos
    E.5.2.1Timepoint(s) of evaluation of this end point
    Clinical Brain Metastasis progression defined as the number of days from the date of randomization to the date of earliest metastasis progression. All metastasis progression is included regardless of whether the subject has discontinued taking the drug. If no metastasis progression, the data will be censored at the date of last neurological assessments. If the subject has no post baseline neurological assessments, then the subject will be censored at the date of randomization
    Overall Survival:Time to death is defined as the number of days from the date of randomization to the subject's death. All events of death are included, regardless of if the subject has discontinued taking the drug. If a subject has not died, then the data will be censored at subject's last known alive date.
    La p.clinica de la Metastasis cerebral se define por el nº de días desde la aleatorización hasta la primera fecha de progresión metastatica. Todas las progresiones metastaticas son incluidas independientemente si el paciente ha interrumpido la medicación. Si no hay progresión metastasica, los datos serán censurados hasta la última evaluación neurologíca.Si el paciente no tiene evaluación neurológica, entonces el paciente será censurado a la fecha aleatorización. La SG global de un paciente:Tiempo hasta la muerte se definirá como el nºde días desde la fecha de aleatorización hasta la fecha de la muerte.Se incluiran todos las muertes independientemente de si el paciente habia dejado la medicación.Si un paciente no ha muerto se censurarán los datos hasta la última fecha que se sabe que vive
    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 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.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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Belgium
    Brazil
    Canada
    Chile
    Czech Republic
    Egypt
    Finland
    Korea, Republic of
    Norway
    Portugal
    Puerto Rico
    Russian Federation
    Spain
    Taiwan
    Ukraine
    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-study is defined as when the subject has experienced either radiographic or clinical brain metastasis progression (whichever occurs last). The Month 24 study visit will be considered the last study visit for subjects who do not experience both radiographic and clinical brain metastasis progression.
    El final de estudio se define como cuando el paciente ha experimentado cualquiera de progresión de la metástasis cerebral radiográfica o clínica (lo que ocurra después). La visita del mes 24 meses de se considerará la última visita del estudio de los pacientes que no experimentan la progresión de la metástasis cerebral radiográfica y clínica.
    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 days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 330
    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)
    Upon completion of the study, the subjects will be treated in accordance with the Investigator's best clinical judgement.
    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 Decision2012-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-01-22
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