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    Summary
    EudraCT Number:2015-000193-35
    Sponsor's Protocol Code Number:MONAVI-1
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-20
    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 ConcernedFrance - ANSM
    A.2EudraCT number2015-000193-35
    A.3Full title of the trial
    A phase II study of ABT-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer
    Etude de phase II évaluant l’intérêt de l'ABT-263 en monothérapie dans le cancer de l'ovaire réfractaire ou platine-résistant
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II study of ABT-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer
    Etude de phase II évaluant l’intérêt de l'ABT-263 en monothérapie dans le cancer de l'ovaire réfractaire ou platine-résistant
    A.3.2Name or abbreviated title of the trial where available
    MONAVI-1
    MONAVI-1
    A.4.1Sponsor's protocol code numberMONAVI-1
    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 SponsorCentre François Baclesse
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPHRC INCa
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre François Baclesse
    B.5.2Functional name of contact pointLECONTE
    B.5.3 Address:
    B.5.3.1Street Address3 avenue du Général Harris
    B.5.3.2Town/ cityCAEN
    B.5.3.3Post code14076
    B.5.3.4CountryFrance
    B.5.4Telephone number330231455002
    B.5.5Fax number330231455158
    B.5.6E-maila.leconte@baclesse.unicancer.fr
    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 nameNAVITOCLAX
    D.3.2Product code ABT-263
    D.3.4Pharmaceutical form Tablet
    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 INNABT-263
    D.3.9.1CAS number 923564-51-6
    D.3.9.2Current sponsor codeABT-263 (A-855071)
    D.3.9.3Other descriptive nameNAVITOCLAX
    D.3.9.4EV Substance CodeSUB37097
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150.0 to 250.0
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Platinum-resistant or refractory ovarian cancer
    Cancer de l'ovaire résistant ou réfractaire au platine
    E.1.1.1Medical condition in easily understood language
    Platinum-resistant or refractory ovarian cancer
    Cancer de l'ovaire résistant ou réfractaire au platine
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10066697
    E.1.2Term Ovarian cancer recurrent
    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 determine activity of ABT-263 for patients with a platinum resistant/refractory recurrent ovarian cancer
    L’objectif principal de cette étude est de déterminer l’activité de l’ABT-263 chez les patientes présentant un cancer de l’ovaire en rechute réfractaire ou résistant au platine
    E.2.2Secondary objectives of the trial
     To determine activity of ABT-263 for patients with a high level of Bim expression determined by immunohistochemistry.
     To assess the overall survival in the whole cohort and in the two subgroups: with high or low Bim expression level
     To evaluate the objective response rate
     To evaluate the toxicity profile
     To evaluate the interest of FDG-PET scan as an indicator of the early response
     To explore the pharmacokinetics of ABT-263
    • Déterminer l’activité de l’ABT-263 dans le sous-groupe de patientes ayant une expression de Bim élevée déterminée par immunohistochimie
    • Déterminer la survie sans progression dans l’ensemble de la population et dans les 2 sous-groupes : avec une faible ou une forte expression de Bim dans la biopsie de rechute au moment de l’inclusion
    • Evaluer le taux de réponse globale
    • Evaluer la survie globale dans l’ensemble de la population de l’étude et dans les 2 sous-groupes : avec une faible ou une forte expression de Bim
    • Evaluer le profil de toxicité
    • Evaluer l’intérêt de la TEP-FDG comme indicateur de réponse précoce.
    • Explorer la pharmacocinétique de l’ABT-263
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PK study including in principal study
    biologial study in ancillar
    Objectives :
    -To extend the assessment to other Bcl-2 family members as well as
    apoptotic and proliferative indexes on both primary tumour and on
    biopsy of relapsing tumour at inclusion in order to define their predictive
    values
    -To constitute biological collections (serum and/or plasma, ascites,
    urines) for further explorations of circulating biomarkers
    Etude de PK incluse dans l'étude principale
    Etude biologique ancillaire

    -•Etendre l'évaluation à d'autres membres de la famille Bcl-2 ainsi qu'à
    d'autres marqueurs de l'apoptose et de la prolifération à la fois sur la
    tumeur initiale et sur la biopsie de la rechute réalisée à l'inclusion afin
    de déterminer leurs valeurs prédictives.
    •Constituer une collection biologique (sérum et/ou plasma, ascite,
    urine) afin d'explorer d'autres biomarqueurs circulants
    E.3Principal inclusion criteria
    -Woman older than 18 years
    -Subjects with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
    -Histologically and/or cytologically documented high grade serous epithelial cancer of ovarian, fallopian tube or peritoneum
    -Platinum resistant ovarian cancer defined as relapsing within 6 months after a platinum based chemotherapy OR platinum refractory ovarian cancer defined as progressing during a platinum based chemotherapy (excepted primary resistant patients)
    -Subjects who are willing and able to comply with the protocol and study procedures including willingness to undergo tumor biopsy before therapy at screening
    -There is no limitation to prior number of therapies
    -Patients must have documented disease progression
    -Subjects who have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
    -Patiente âgée de 18 ans ou plus
    -Patiente présentant un ECOG ≤ 2
    -Cancer de haut grade de type séreux de l’ovaire, des trompes de fallope ou du péritoine histologiquement ou cytologiquement prouvé.
    -Résistance au platine définie par une rechute dans les 6 mois de la fin d’une chimiothérapie à base de platine OU réfractaire au platine définie par une progression de la maladie pendant la chimiothérapie à base de sels de platine (les patientes avec une résistance primaire ne sont pas admises)
    -Patientes acceptant les modalités du protocole ainsi que les procédures qui y sont associées incluant la réalisation d’une biopsie au screening
    -Les patientes peuvent avoir reçu plusieurs lignes de chimiothérapies quelque soit le nombre de lignes
    -Progression tumorale documentée
    -Patiente présentant une maladie mesurable selon les critères RECIST v1.1
    E.4Principal exclusion criteria
    -Patient’s refusal or impossibility to perform biopsy on relapsing disease
    -Bowel occlusive syndrome or other gastro-intestinal disorder that does not allow oral medication such as malabsorption
    -Patients with platinum primary resistant disease
    -Received radio-immunotherapy within 6 months of 1st dose of study drug
    -Received steroid therapy for anti-neoplastic intent within 7 days of the 1st dose of study drug (Inhaled steroids for asthma, topical steroids, replacement/stress corticosteroids, or corticosteroids taken as premedication are allowed)
    -Consumption of grapefruit or grapefruit products within 3 days prior to the first dose of study drug
    -Patient receiving treatments strong CYP3A4 inhibitors or inducers (Appendix A)
    -Positive for HIV
    -Predisposing condition/currently exhibiting signs of bleeding
    -Currently receiving anticoagulation therapy, exception of low-dose anticoagulation medications for prophylaxis
    -Received aspirin within 7 days of start dose of study drug
    -Active peptic ulcer disease / other potentially hemorrhagic esophagitis/gastritis
    -Active immune thrombocytopenic purpura, autoimmune hemolytic anemia or history of being refractory to platelet transfusions (within 1 year of 1st dose of study drug)
    -Uncontrolled cardiac, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease, active systemic fungal infection; diagnosis of fever and neutropenia within 1 week of study drug administration
    -A evidence of current/active malignancies other than ovarian cancer
    -Pregnant or lactating women
    -Refus du patient ou impossibilité de réaliser une biopsie sur la rechute
    -Syndrome occlusif ou maladie gastro-intestinale ne permettant pas l’absorption orale des médicaments
    -Patientes avec une résistance primaire aux sels de platine
    -Traitement par radio-immunothérapie dans les 6 mois du début de la chimiothérapie
    -Administration de corticothérapie à visée anti-tumorale dans les 7 jours précédant le début de la chimiothérapie (les corticoïdes inhalés pour asthme, les corticoïdes topiques, les traitements substitutifs de l’insuffisance surrénale (replacement/stress corticosteroids) ou les prémédications par corticoïdes sont autorisés)
    -Consommation de pamplemousse dans les 3 jours précédant le début de la chimiothérapie
    -Patientes ayant reçu des traitements par inhibiteur ou inducteurs du CYP3A4
    -Histoire récente de thrombopénie avec hémorragie
    -Patiente HIV positive
    -Antécédents de syndrome hémorragique antérieur ou saignement actif
    -Patiente recevant un traitement anticoagulant (sauf à faible dose en prophylaxie)
    -Administration d’aspirine dans les 7 jours précédant le début de la chimiothérapie
    -Ulcère gastro-duodénal actif, oesophagite ou gastrite potentiellement hémorragique
    -Thrombopénie auto-immune active, anémie hémolytique auto-immune ou antécédent de résistance aux transfusions plaquettaires (dans l’année précédant la première dose de traitement à l’étude)
    -Pathologies cardiaques, rénales, neurologiques, psychiatriques, endocrinologiques, métaboliques, immunologiques ou hépatiques non contrôlées ou infection active sévère ; fièvre avec neutropénie dans la semaine de la première chimiothérapie sont exclues
    -Autre pathologie cancéreuse active en dehors du cancer de l’ovaire
    -Femme enceinte ou allaitante
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the progression-free survival (PFS) in the whole cohort of patients with a recurrent platinum-resistant ovarian cancer.
    Progression-free survival is defined as the time to progression (or death from any cause) from ABT-263 treatment start, with censoring patients who have not progressed at the end of the study, on the date of last news.
    The progression is defined according to Recist Criteria.
    Le critère d’évaluation primaire est la survie sans progression (PFS) de la maladie dans l’ensemble de la cohorte des patientes présentant un cancer de l’ovaire en rechute réfractaire ou résistant au platine
    La survie sans progression est définie par le temps entre la progression (ou décès de toute cause) et le début du traitement par ABT-263, en excluant les patientes n’ayant pas progressé à la fin de l’étude ou la date des dernières nouvelles.
    La progression de la maladie est définie selon les critères RECIST v1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at disease progression (or death from any cause)
    à la progression (ou décès de toute cause)
    E.5.2Secondary end point(s)
    -Bim expression level expressed by immunohistochemistry on biopsy of relapsing tumor at inclusion
    -Response rate defined by a complete response (CR), a partial response (PR) or a stable disease (SD) according to the RECIST v1.1 criteria.
    -Overall survival (OS), defined as time to death from treatment start, with censoring patients alive at the end of the study, on the date of last news.
    -Toxicities defined according to the NCI CTC AE version 4.0.
    -Pharmacokinetics of ABT-263
    -Le niveau d’expression de Bim sera déterminé par immunohistochimie sur la biopsie de récidive à l’inclusion
    -Survie sans progression (PFS), définie comme le temps jusqu’à progression (ou le décès quelqu’en soit la cause) depuis le début de traitement par ABT-263, en excluant les patientes qui n’auront pas progressées à la fin de l’étude, à la date des dernières nouvelles.
    -La survie globale (OS), définie comme le temps entre le début de traitement et le décès, en excluant les patients toujours en vie à la fin de l’étude, à la date des dernières nouvelles.
    -Les toxicités définies selon les NCI CTC AE version 4.0
    -La pharmacocinétique de l’ABT -263.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Bim level determined by immunohistochemistry
    and expressed as low, medium or high.
    -Progression free survival (PFS), defined as time to progression (or death for any cause) from ABT-263 treatment start, with censoring patients who have not progressed at the end of the study, on the date of
    last news
    -Overall survival (OS), defined as time to death from treatment start,with censoring patients alive at the end of the study, on the date of last news.
    -Toxicities defined according to the NCI CTC AE version 4.0.
    -Pharmacokinetics of ABT-263
    -Le niveau d'expression de Bim sera déterminé par immunohistochimie et exprimé en bas, moyen ou haut.
    -Survie sans progression (PFS), définie comme le temps jusqu'à progression (ou le décès quelqu'en soit la cause) depuis le début de traitement par ABT-263, en excluant les patientes qui n'auront pas progressées à la fin de l'étude, à la date des dernières nouvelles.
    -La survie globale (OS), définie comme le temps entre le début de traitement et le décès, en excluant les patients toujours en vie à la fin de l'étude, à la date des dernières nouvelles.
    -Les toxicités définies selon les NCI CTC AE version 4.0
    -La pharmacocinétique de l'ABT -263.
    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 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 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 No
    E.8.1.1Randomised No
    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 No
    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 concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Subjects could remain on therapy indefinitely, until disease progression
    or intolerable toxicity.
    Les patientes peuvent poursuivre le traitement indéfiniment jusqu'à
    progression de la maladie ou toxicité inacceptable
    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 months
    E.8.9.1In the Member State concerned days
    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: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state46
    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)
    none
    aucun
    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 Decision2015-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-08
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