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    Summary
    EudraCT Number:2012-001144-22
    Sponsor's Protocol Code Number:ML28337
    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:2012-09-03
    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 number2012-001144-22
    A.3Full title of the trial
    A RANDOMIZED, OPEN-LABEL, PHASE II STUDY ASSESSING THE EFFICACY AND THE SAFETY OF BEVACIZUMAB IN NEOADJUVANT THERAPY IN PATIENTS WITH FIGO STAGE IIIC/IV OVARIAN, TUBAL OR PERITONEAL ADENOCARCINOMA, INITIALLY UNRESECTABLE.
    Etude de phase II randomisée menée en ouvert évaluant l’efficacité et la tolérance du bevacizumab en traitement néoadjuvant chez des patientes présentant un adénocarcinome ovarien de stade Figo IIIC/IV, tubaire ou péritonéal initialement non résécable
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study assessing the efficacy and the safety of bevacizumab in association with a standard chemotherapy before surgery of ovarian cancer
    Etude évaluant l'efficacité et la tolérance de bevacizumab en association avec une chimiothérapie standard avant chirurgie d'un cancer de l'ovaire
    A.3.2Name or abbreviated title of the trial where available
    ANTHALYA
    A.4.1Sponsor's protocol code numberML28337
    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 SponsorROCHE SAS
    B.1.3.4CountryFrance
    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 supportRoche S.A.S.
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationROCHE
    B.5.2Functional name of contact pointOpérations Cliniques/Direction Médi
    B.5.3 Address:
    B.5.3.1Street Address30 cours de l'Ile Seguin
    B.5.3.2Town/ cityBOULOGNE BILLANCOURT
    B.5.3.3Post code92650
    B.5.3.4CountryFrance
    B.5.6E-mailessais.cliniques@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 Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd.
    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 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.3.9.2Current sponsor codeRO4876646
    D.3.9.3Other descriptive namerhuMAb VEGF, anti-VEGF
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant humanized monoclonal antibody
    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
    Epithelial ovarian cancer
    Fallopian tube carcinoma
    Primary peritoneal carcinoma
    Cancer épithélial de l'ovaire
    Carcinome des trompes de Faloppe
    Carcinome péritonéal primitif
    E.1.1.1Medical condition in easily understood language
    Ovarian Cancer
    Cancer de l'ovaire
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10052204
    E.1.2Term Ovarian carcinosarcoma
    E.1.2System Organ Class 100000021045
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10016180
    E.1.2Term Fallopian tube 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    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 evaluate the efficacy of neoadjuvant bevacizumab and chemotherapy measured by the complete resection rate after interval debulking surgery (IDS).
    Complete resection is defined as the removal of all macroscopic residual tumour at IDS (Completeness of Cytoreduction (CC) score = 0).
    Evaluer l’efficacité du bevacizumab associé à une chimiothérapie néoadjuvante mesurée par le taux de résection complète après chirurgie d’intervalle.
    La résection complète est définie comme étant l’absence de toute tumeur macroscopique résiduelle après la chirurgie d’intervalle (Score CC= 0)
    E.2.2Secondary objectives of the trial
    * To assess the safety profile of bevacizumab when added to carboplatin and paclitaxel neoadjuvant and adjuvant chemotherapy.

    * To assess the efficacy of bevacizumab measured by:
    • Objective Response Rate (ORR) assessed according to RECIST criteria (v 1.1) and/or CA-125 levels :
    - Before IDS (neoadjuvant phase)
    - After all courses of treatment (16 months following IDS)
    • Progression-free survival (PFS).
    * Evaluer le profil de tolérance du bevacizumab associé au Carboplatine et au Paclitaxel en néo adjuvant puis à une chimiothérapie adjuvante.

    * Evaluer l’efficacité du bevacizumab mesurée par:
    • Le taux de réponse objective évalué selon les critères RECIST (v 1.1) et/ou le taux de CA 125 :
    - avant chirurgie d’intervalle (phase néo adjuvante)
    - après tous les cycles de traitement (jusqu'à 16 mois après la chirurgie d’intervalle)
    • La survie sans progression (PFS)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    One blood sample for inherited biomarker discovery will be collected from all patients participating in this clinical trial for pharmacogenetic and genetic research before treatment start.

    Evaluate first T cell repertoire diversity as a predictive biomarker of bevacizumab efficacy at baseline and during treatment in all included patients and second the impact of treatment and IDS on T cell repertoire diversity to highlight a possible difference between arms
    Un échantillon sanguin pour la recherche de bio-marqueurs héréditaires sera recueilli auprès de toutes les patientes participant à cette recherche pharmacogénétique et génétique, avant le début du traitement.

    Explorer d'une part pour toutes les patientes incluses la diversité du répertoire immunitaire T comme biomarqueur prédictif de l'efficazcité du bevacizumab à l'inclusion et pendant le traitement et d'autre part l'impact du traitement et de la chirurgie d'intervalle sur la diversité immunitaire afin de mettre en évidence une possible différence entre les deux bras.
    E.3Principal inclusion criteria
    - Written, informed consent obtained prior to any study-specific procedure
    - Woman aged ≥ 18 years
    - Histologically confirmed and documented, by peritoneal biopsy, high risk epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma
    - Patients are required to be deemed by a surgeron experienced in the management of ovarian cancer not to be eligible for primary complete debulking surgery during a laparoscopic procedure.
    - Consentement éclairé signé, obtenu avant toute procédure ou traitement spécifique de l’étude
    - Femme d’âge ≥ 18 ans.
    - Patientes présentant un carcinome épithélial ovarien ou un carcinome des trompes de Fallope ou un carcinome péritonéal primaire, histologiquement confirmé par une biopsie péritonéale
    - Patientes jugées non éligibles pour une cytoréduction tumorale initiale par un chirurgien expérimenté dans la prise en charge du cancer ovarien pendant la laparoscopie.
    E.4Principal exclusion criteria
    * Patient with:
    • non-epithelial ovarian cancer
    • ovarian tumour with low malignant potential (i.e. borderline tumour)
    • inadequate bone marrow, liver or renal function
    • Carcinosarcoma

    * Previous systemic therapy for ovarian cancer (i.e. chemo-, immuno-, hormonal, monoclonal antibody or tyrosine kinase inhibitor therapy)

    * Planned intraperitoneal cytotoxic chemotherapy
    * Patientes présentant:
    • Un cancer ovarien non-épithélial
    • Une tumeur ovarienne avec un faible potentiel de malignité (ex. tumeur borderline)
    • Troubles des fonctions médullaire, rénale ou hépatique.
    • carcinosarcome

    * Traitement systémique antérieur du cancer ovarien (ex. chimiothérapie, immunothérapie, thérapie hormonale, anticorps monoclonaux or inhibiteurs de la tyrosine kinase).
    E.5 End points
    E.5.1Primary end point(s)
    Complete resection is defined as the removal of all macroscopic residual tumour at IDS (CC score = 0) based on standardized operative report.
    La résection complète sera définie comme étant la suppression de toute tumeur macroscopique résiduelle lors de la chirurgie d’intervalle (CC score 0) basée sur le compte rendu opératoire standardisé.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the interval debulking surgery after the neo adjuvant therapy
    A la chirurgie d'intervalle après la période néo-adjuvante.
    E.5.2Secondary end point(s)
    - Efficacy : Objective Response Rate for the neoadjuvant period (defined from the baseline to IDS) and ORR after all courses of treatment will be assessed.
    Progression Free survival (PFS) will be assessed.
    Tumour assessments (based on RECIST V. 1.1 criteria) will include cross-sectional imaging (preferably by CT, or MRI in case of contrast allergy) of the pelvis and abdomen. Other modalities should be used as appropriate to ensure that adequately imaged and followed for signs of PD.
    Tumour assessments must be performed using the same imaging technique for a patient, throughout the trial.

    - Safety : Complete physical examination, measurement of vital signs, laboratory safety assessments according to local standards and recording of AEs according to the National Cancer Institute’s Cancer Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4 grades 1-5 will be performed by the investigator.
    -Efficacité : Le Taux de Réponse Objective pour la période néo-adjuvante (comprise entre l’inclusion et la chirurgie d'intervalle) et le Taux de Réponse Objective après tous les cycles de traitement seront évalués.
    La survie sans progression sera évaluée.
    Les évaluations tumorales abdomino-pelviennes (basées sur les critères RECIST V1.1) seront faites par imagerie en coupe transversale (de préférence par CT ou IRM en cas d’allergie aux agents de contraste). D'autres méthodes pourront être utilisées, si nécessaire, pour s’assurer de la qualité de l’imagerie et du suivi de la maladie.
    Pour chaque patiente, les évaluations tumorales doivent être effectuées en utilisant la même technique d'imagerie tout au long de l’essai.

    - Tolérance : Un examen physique complet, la mesure des signes vitaux, les examens biologiques selon les pratiques locales et le recueil des évènements indésirables (EI de grade 1 à 5 selon NCI-CTC) seront effectués par l’investigateur.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy : Tumour assessments will be performed at baseline, before IDS, before Cycle 8, then every 6 cycles (+/- 2 weeks of the scheduled visit) while the patient is receiving bevacizumab, at cessation of bevacizumab (+/- 4 weeks of the scheduled visit), every 6 months during follow-up, until disease progression . CA 125 will be performed at baseline, at each cycle before IDS, at IDS, before Cycle 5, at the end of Cycle 8, then every 6 cycles during treatment, at 28 days after end of treatment, every 6 months during follow-up, until disease progression
    - Safety : throughout the participation of the patient at this study
    - Efficacité : Les évaluations tumorales seront effectuées à l’inclusion, avant la chirurgie d’intervalle, avant le cycle 8, puis tous les 6 cycles (+/- 2 semaines par rapport à la date de visite prévue) pendant la période de traitement par bevacizumab, à l'arrêt du bevacizumab (+/- 4 semaines par rapport à la date de visite prévue) et tous les 6 mois pendant la période de suivi, jusqu'à progression. Le CA 125 sera réalisé au screening, avant la chirurgie d’intervalle, avant le cycle 5, et à la fin du cycle 8 puis tous les 6 cycles durant la période de traitement, tous les 6 mois pendant la période de suivi et jusqu'à progression de la maladie.
    - Tolérance : tout le temps de la participation d'une patiente à l'essai.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 No
    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 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 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 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
    Patients will be followed for progression-free survival until 6 months after the last treatment cycle of the last patient on treatment. A stopping rule will be implemented during the neoadjuvant period, at IDS and during 30 days following IDS. The study will stop if more than 20% of severe complications (graded according to the NCI-CTCAE) occur during this period. The list of severe complications is provided in Section.5.
    Les patientes seront suivies jusqu'à progression et jusqu'à 6 mois après le dernier cycle de traitement de la dernière patiente. Une procédure d'arrêt sera mise en œuvre pendant la période néo-adjuvante, à la chirurgie d’intervalle et durant les 30 jours suivant la chirurgie d’intervalle. L'étude sera interrompue si plus de 20% de complications sévère (classées selon le NCI-CTC) se produisent lors de cette période. Une liste de ces complications sévères est notifiée dans la section 5.
    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 months1
    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.1.3Elderly (>=65 years) Yes
    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 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 state205
    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 Decision2012-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-17
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