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    Summary
    EudraCT Number:2011-006288-23
    Sponsor's Protocol Code Number:GINECO-OV-119
    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:2012-09-04
    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 number2011-006288-23
    A.3Full title of the trial
    Randomized double blind placebo-controlled phase II trial of Vargatef® in addition to first line chemotherapy with interval debulking surgery in patients with adenocarcinoma of the ovary, the fallopian tube or serous adenocarcinoma of the peritoneum
    Essai randomisé en double aveugle de phase II évaluant le Vargatef® (Nintedanib) en concomitance d’une première ligne de chimiothérapie avec chirurgie d’intervalle chez les patientes présentant un cancer de l’ovaire, de la trompe ou du péritoine.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of efficacy and safety of using Nintedanib (Vargatef®) as part of the neoadjuvant and adjuvant treatment surrounding interval debulking surgery in patients with advanced ovarian cancer
    A.3.2Name or abbreviated title of the trial where available
    CHIVA
    A.4.1Sponsor's protocol code numberGINECO-OV-119
    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 SponsorARCAGY
    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 supportBoehringer INgelheim
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationARCAGY
    B.5.2Functional name of contact pointBéatrice Houy
    B.5.3 Address:
    B.5.3.1Street AddressHôpital Hôtel Dieu 5ème B2 Place du parvis Notre Dame
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75181 cedex4
    B.5.3.4CountryFrance
    B.5.4Telephone number33142348323
    B.5.5Fax number33143262673
    B.5.6E-mailbhouy@arcagy.org
    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 nameNintedanib
    D.3.2Product code BIBF1120
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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, soft
    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
    Patients with newly diagnosed FIGO stage IIIC - IV epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal
    carcinomas with indication for a carboplatin/paclitaxel chemotherapy framing an interval debulking surgery
    E.1.1.1Medical condition in easily understood language
    Patients with newly diagnosed FIGO stage IIIC - IV ovarian cancer with indication for a chemotherapy and an interval surgey.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    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 determine the median Progression-free Survival (PFS) in each study arm (neoadjuvant/adjuvant treatment with or without Nintedanib(Vargatef®).
    E.2.2Secondary objectives of the trial
    - To evaluate the operative and post-operative complications rate
    - To evaluate response rate (using RECIST 1.1 and Sugarbaker index) and rate of complete debulking.
    - To evaluate Biological progression-free interval (PFIbio) by serum CA-125 assessed according to the GCIG criteria
    - To evaluate best response, overall survival
    - To assess quality of life
    - To assess biological activity of BIBF1120 (Vargatef®) and pharmacodynamic markers in blood and in pre/post surgery tumour biopsies.
    - To describe relations between tumour characteristics (e.g. tumour genotype, gene expression profile etc) and anti-tumour activity.
    E.2.3Trial contains a sub-study Yes
    E.3Principal inclusion criteria
    • First diagnosis of histological confirmed (cytology alone excluded) epithelial ovarian cancer, fallopian tube or primary peritoneal cancer. Histology should be obtained by laparoscopy (or by laparotomy),
    • FIGO-Stages IIIC – IV,
    • Females, age 18 years or older,
    • Life expectancy of at least 6 months,
    • ECOG performance status < 2,
    • Primary debulking surgery denied and maximum surgical effort of cytoreduction with the goal of no residual disease planned as interval debulking surgery,
    • Patient has given written informed consent,
    • Interval between diagnosis and enrolment (informed consent) ≤ 8 weeks,
    • Adequate hepatic, renal and bone marrow functions.
    E.4Principal exclusion criteria
    • Histological diagnosis of malignant tumour of non-epithelial origin (e.g. germ cell tumour, malignant mixed mullerian tumour, sex cord-stromal tumour) of the ovary, the fallopian tube or peritoneum or borderline tumour of the ovary (tumour of low malignant potential),
    • Non-healing wound, ulcer (intestinal tract, skin) or bone fracture,
    • Clinical symptoms or signs of gastrointestinal obstruction that require parenteral nutrition and/or hydration,
    • History of major thromboembolic event,
    • History of at least 2 unprovoked (without a transient or reversible risk factor) events of proximal deep venous thrombosis,
    • Prior thrombosis or thromboembolic event in the presence of an inherited coagulopathy (including deficiency of antithrombin, deficiency of protein C or protein S, Factor V Leiden mutation, Prothrombin G20210A mutation),
    • Patients with perioperative thrombosis including proximal deep vein thrombosis (DVT) or thrombosis of visceral vessels not associated with pulmonary embolism may be included in the trial if stable therapeutic anticoagulation is documented,
    • Known inherited or acquired bleeding disorder,
    • Significant cardiovascular diseases,
    • Peripheral vascular disease Fontaine stage ≥3,
    • Clinically relevant pericardial effusion (e.g. pericardial effusion with echocardiographic or clinical signs of haemodynamic impairment),
    • History of a cerebral vascular accident, transient ischemic attack or subarachnoid hemorrhage within the past 6 months,
    • Serious infections in particular if requiring systemic antibiotic (antimicrobial,
    antifungal) or antiviral therapy,
    • Poorly controlled diabetes mellitus or other contraindication to high dose corticosteroid therapy,
    • Clinical symptoms of brain metastases and/or diagnosis of brain metastases on imaging,
    • Pre-existing sensory or motor neuropathy CTCAE ≥ 2, except due to trauma,
    • Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug,
    • Other malignancy diagnosed within the past 5 years,
    • Prior systemic therapy for ovarian cancer (e.g. chemotherapy, monoclonal antibody therapy, oral targeted therapy, hormonal therapy),
    • Prior radiotherapy to the abdomen or prior radiotherapy to an extra-abdominal target volume that would bear the risk of increased toxicity of chemotherapy,
    • Hypersensitivity to BIBF 1120 and/or the excipients of the trial drugs,
    • Serious illness or concomitant non-oncological disease such as neurologic, psychiatric or infectious disease, active ulcers (gastrointestinal tract, skin) or a laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study,
    • Patients with preserved reproductive capacity who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner) during the trial and for at least twelve months after end of active therapy,
    • Pregnancy or breast feeding,
    • Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule,
    • Active alcohol or drug abuse,
    • Any contraindications for therapy with paclitaxel or carboplatin, e.g. a history of severe hypersensitivity reactions to paclitaxel or platinum-containing compounds and their excipients, or other drugs formulated with Polyoxyl 35 Castor Oil – ELP,
    • Treatment with other investigational drugs or participation in another clinical trial testing a drug within the past four weeks before start of therapy or concomitantly with this trial.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At least 130 PFS events have been observed (83 in experimental group and 47 in control group)
    E.5.2Secondary end point(s)
    - Response rate
    - Rate of complete debulking
    - biological Progression Free Survival
    - Best response
    - Overall survival (OS)
    - Quality of life (QoL)
    - Safety and tolerability
    Further exploratory outcome measures on ancillary studies will include:
    - Translational Sub Studies
    E.5.2.1Timepoint(s) of evaluation of this end point
    OS: 5.5 years appr.
    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 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 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 concerned40
    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
    the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    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: 188
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 state188
    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)
    Standard of care
    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 Decision2012-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-11-15
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