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    Summary
    EudraCT Number:2016-002738-55
    Sponsor's Protocol Code Number:69HCL16-0134
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-01-20
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-002738-55
    A.3Full title of the trial
    Safety of Intraperitoneal (IP) OXAliplatin (OXA) in Association With Systemic FOLFIRI Bevacizumab Chemotherapy in Patients With Peritoneal Carcinosis ( IPOXA )
    IPOXA, Essai de Phase I/II en escalade de dose visant à évaluer la tolérance de l’administration Intra-péritonéale (IP) d’OXAliplatine (OXA) en association avec une chimiothérapie systémique de type FOLFIRI Bevacizumab chez des patients atteints de carcinose péritonéale d’origine colorectale de résécabilité incertaine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety of Intraperitoneal (IP) OXAliplatin (OXA) in Association With Systemic FOLFIRIBevacizumab Chemotherapy in Patients With Peritoneal Carcinosis ( IPOXA )
    IPOXA, Essai de Phase I/II en escalade de dose visant à évaluer la tolérance de l’administration Intra-péritonéale (IP) d’OXAliplatine (OXA) en association avec une chimiothérapie systémique de type FOLFIRI Bevacizumab chez des patients atteints de carcinose péritonéale d’origine colorectale de résécabilité incertaine
    A.3.2Name or abbreviated title of the trial where available
    IPOXA
    IPOXA
    A.4.1Sponsor's protocol code number69HCL16-0134
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02866903
    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 SponsorHospices Civils de Lyon
    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 supportDirection Générale des Offres de Soins (French Health Ministry)
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportCanceropôle Lyon Auvergne Rhône-Alpes
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospices Civils de Lyon
    B.5.2Functional name of contact pointIUNG Annie
    B.5.3 Address:
    B.5.3.1Street Address3 Quai des célestins
    B.5.3.2Town/ cityLYON
    B.5.3.3Post code69002
    B.5.3.4CountryFrance
    B.5.4Telephone number330472406824
    B.5.5Fax number3300472115190
    B.5.6E-maildrci_promo@chu-lyon.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 Yes
    D.2.1.1.1Trade name OXALIPLATIN
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameOXALIPLATIN
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIRINOTECAN
    D.3.9.3Other descriptive nameIRINOTECAN HYDROCHLORIDE TRIHYDRATE
    D.3.9.4EV Substance CodeSUB45873
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number140 to 165
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFluorouracile
    D.3.9.3Other descriptive nameFLUOROURACIL
    D.3.9.4EV Substance CodeSUB07721MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2400 to 2800
    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.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Patients with peritoneal carcinosis of colorectal origin and uncertain resectability with an indication for systemic chemotherapy compatible with the FOLFIRI + bevacizumab combination.
    Patient ayant un cancer colorectal localement avancé ou métastatique compliqué d’une carcinose péritonéale de résécabilité incertaine avec une indication de chimiothérapie systémique compatible avec l’association FOLFIRI + bevacizumab
    E.1.1.1Medical condition in easily understood language
    Advanced or Metastatic colorectal carcinosis
    Cancer colorectal localement avancé ou métastatique
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10052171
    E.1.2Term Peritoneal carcinoma
    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 recommended dose (to be used in phase II) and safety of first cycle of intraperitoneal oxaliplatine treatment in combination with systemic chemotherapy FOLFIRI + bevacizumab for patients with peritoneal carcinosis of colorectal origin and uncertain resectability
    Evaluer la tolérance durant le premier cycle de traitement et la dose recommandée pour les essais de phase II de l’administration intra-péritonéale de l’oxaliplatine en association avec une chimiothérapie systémique de type FOLFIRI + bevacizumab chez des patients présentant une CP d’origine colorectale de résécabilité incertaine
    E.2.2Secondary objectives of the trial
    To evaluate preliminary clinical efficacy related to the repeated administration of intraperitoneal chemotherapy for patients with peritoneal carcinosis of colorectal origin and uncertain resectability with an indication for systemic chemotherapy compatible with the FOLFIRI + bevacizumab combination
    To assess patient’s safety throughout the treatment (maximum of 8 cycles or 4 months’ treatment) until the end/patient's study involvement to be able to evaluate cumulative toxicity
    - Obtenir des données préliminaires sur l'efficacité clinique de l'administration IP de l'oxaliplatine donné en combinaison avec une chimiothérapie systémique de type FOLFIRI + bevacizumab chez des patients présentant une CP d'origine colorectale de résécabilité incertaine
    - Evaluer la tolérance pendant toute la durée du traitement (pour un maximum de 8 cycles, soit 4 mois de traitement) et jusqu'à la fin de participation à l'étude du patient, de l'administration IP de l'oxaliplatine donné en combinaison avec une chimiothérapie systémique de type FOLFIRI + bevacizumab, afin d'évaluer les toxicités cumulées
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - To assess pharmacokinetic charactericistics of oxaliplatine in blood and peritoneal liquid
    - To assess oxaliplatine distribution by peritoneum scanner and its relationship with intraperitoneal treatment response
    - To assess kinetic decrease of circulating tumor markers by mathematic modelling
    - Impact of genomic biomeker in chemotherapy response
    - Evaluer les caractéristiques pharmacocinétiques de l’oxaliplatine dans le liquide péritonéal et le sang lorsque celui-ci est administré directement dans la cavité IP
    - Evaluer par scanner avec péritonéographie la distribution de l’oxaliplatine dans la cavité péritonéale
    - Evaluer les propriétés cinétiques de la décroissance des marqueurs tumoraux circulants (ACE, CA 19-9, acides nucléiques tumoraux) par modélisImpact d’un panel de biomarqueurs génomiques sur la réponse à la chimiothérapie ation mathématique
    -
    E.3Principal inclusion criteria
    • ≥18 years old and ≤ 75 years old
    • ECOG Performance Status (PS) 0-2
    • Peritoneal carcinosis with locoregional extension or metastastic of colorectal origin
    and uncertain resectability
    • PCI > 20 and / or infiltration of the hepatic pedicle and / or necessary digestive tract
    resections
    • Systemic chemotherapy indication, compatible with the FOLFIRI + bevacizumab
    combination
    • Satisfactory haematological evaluation: PNN rate greater than 1500 / mm3, platelet
    count greater than 100 G / l;
    • Satisfactory renal and hepatic function : serum creatinine ≤1.5 times the normal
    lower values or creatinine clearance ≥50 ml / min, bilirubin ≤1.25 times lower
    normal values, AST / ALT ≤1.5 times the lower normal values (≤5 times the lower
    normal values for patients with liver metastases)
    • No unstable conditions: myocardial infarction within 6 months prior to the start
    of the study, congestive heart failure, unstable angina, active cardiomyopathy,
    unstable rhythm disorder, uncontrolled hypertension, uncontrolled psychiatric
    disorders, severe infection, peptic ulcer or any condition that could be aggravated
    by treatment or limit compliance (investigator assessment);
    • No limitation in the number of previous treatments;
    • Patients may have received conventional cytotoxic chemotherapy , hormonal or immunological targeted biological agents. They should have recovered from previous grade ≤2 toxicities
    • Written informed consent
    • Known RAS status.
    - Age : ≥18 ans et  75 ans ;
    - ECOG PS 0-2 ;
    - Cancer colorectal localement avancé ou métastatique compliqué d’une carcinose péritonéale de résécabilité incertaine :
    - PCI > 20
    Et/ou
    - Infiltration pédicule hépatique
    - Résections digestives étendues nécessaires
    - Indication de chimiothérapie systémique, compatible avec l’association FOLFIRI + bevacizumab
    - Bilan hématologique satisfaisant :
    - Taux de Polynuclaires Neutrophiles (PNN) supérieur à 1500 / mm3
    - Taux de plaquettes supérieur à 100 G/l
    - Bilans rénal et hépatique satisfaisants :
    - Créatinine sérique ≤1.5 fois les valeurs normales inférieures ou clairance de la créatinine ≥ 50 ml/mn
    - Bilirubine totale ≤1.25 fois limites normales inférieures
    - ASAT/ALAT ≤1.5 fois les limites normales inférieures (≤5 fois les limites normales inférieures pour les patients avec métastases hépatiques)
    - Absence de pathologies instables : infarctus du myocarde dans les 6 mois précédant le début de l’étude, insuffisance cardiaque congestive, angor instable, cardiomyopathie active, trouble du rythme instable, hypertension artérielle non contrôlée, troubles psychiatriques non contrôlés, infection sévère, ulcère peptique, ou toute pathologie qui pourrait être aggravée par le traitement ou limiter la compliance (jugement de l’investigateur) ;
    - Pas de limitation dans le nombre antérieur de traitements ;
    - Les patients peuvent avoir reçu des chimiothérapies cytotoxiques conventionnelles, des agents biologiques immunologiques hormonaux ou ciblés. Ils doivent avoir récupéré des toxicités antérieures avec un grade ≤2 ;
    - Consentement éclairé, écrit et signé après information ;
    - Statut RAS connu
    E.4Principal exclusion criteria
    Extraperitoneal metastases for which the site or number preclude potentially curative surgery at any moment during the course of the disease
    • Sign of bowel obstruction or lesions whose topography indicates a risk of intestinal
    perforation or inflammatory bowel disease
    • ECOG PS 3-4
    • Contraindication to the placement of a intraperitoneal central line
    • Contraindication specifically related to intraperitoneal administration of oxaliplatin
    • known history of hypersensitivity to oxaliplatin or to the excipients
    • peripheral sensory neuropathy grade ≥2
    • Pregnant or lactating women
    • Unable to give consent
    • Patient under legal protection measures
    • Refusal to participate in the study
    Extraperitoneal metastases for which the site or number preclude potentially curative surgery at any moment during the course of the disease
    • Sign of bowel obstruction or lesions whose topography indicates a risk of intestinal perforation or inflammatory bowel disease
    • ECOG PS 3-4
    • Contraindication to the placement of a intraperitoneal central line
    • Contraindication specifically related to intraperitoneal administration of oxaliplatin
    • known history of hypersensitivity to oxaliplatin or to the excipients
    • peripheral sensory neuropathy grade ≥2
    • Pregnant or lactating women
    • Unable to give consent
    • Patient under legal protection measures
    • Refusal to participate in the study
    E.5 End points
    E.5.1Primary end point(s)
    The safety of intraperitoneal (IP) administration of oxaliplatin in combination with systemic chemotherapy FOLFIRI +
    bevacizumab will be evaluated during the first cycle of therapy according to NCI CTCAE version 4.0
    The safety of intraperitoneal (IP) administration of oxaliplatin in combination with systemic chemotherapy FOLFIRI +
    bevacizumab will be evaluated during the first cycle of therapy according to Dose Limiting Toxicities
    La tolérance de l’administration intra-péritonéale (IP) de l’oxaliplatine en association avec une chimiothérapie systémique de type FOLFIRI + bevacizumab sera évaluée durant le premier cycle du traitement par la mesure des effets indésirables évalués d’après le NCI CTCAE version 4.0.
    Les Doses Limite de Toxicité sont définies comme n’importe quel évènement suivant observé durant le premier cycle du traitement et jugé selon l’investigateur comme étant possiblement lié au traitement en cours
    E.5.1.1Timepoint(s) of evaluation of this end point
    First Cycle 1
    Premier Cycle 1
    E.5.2Secondary end point(s)
    1. Overall response rate according to RECIST
    2. Clinical efficacy of intraperitoneal (IP) administration of oxaliplatin in combination with systemic FOLFIRI + bevacizumab assessed by the overall response rate according to RECIST version 1.1 criteria assessed by imaging (TAP scanner and / or MRI if contraindication)
    4. Peritoneal Cancer Index (PCI)
    Clinical efficacy of intraperitoneal (IP) administration of oxaliplatin in combination with systemic FOLFIRI +
    bevacizumab assessed by Peritoneal Cancer Index (PCI) performed after 4 cycles, and / or after 8 cycles
    5. Adverse events (NCI CTCAE v4.0)
    [Time Frame: up to 5 months] [Safety Issue: No]
    The safety of intraperitoneal (IP) administration of oxaliplatin in combination with systemic chemotherapy FOLFIRI +
    bevacizumab will be evaluated throughout the duration of treatment (4 months) and until the end of patient follow up (1 month after treatment discontinuation) according to NCI CTCAE version 4.0
    - Taux de réponse globale suivant les critères RECIST version 1.1 évalué par imageries (scanner TAP et/ou IRM en cas de contre-indication)
    - Effets indésirables évalués d’après le NCI CTCAE version 4.0 durant toute la durée du traitement et jusqu’à la fin de participation à l’étude du patient ;
    - Peritoneal Cancer Index (PCI) total mesuré selon l’Index de Sugarbaker lors de la coelioscopie (ou laparotomie) de réévaluation faite en cas de réponse complète/partielle/stabilisation au scanner TAP
    E.5.2.1Timepoint(s) of evaluation of this end point
    Performed after 4 cycles, and / or after 8 cycles
    Après 4 cycles et/ou 8 cycles
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Determination of Recommended dose with Safety of Intraperitoneal administration of oxaliplatin
    Détermination de la dose recommandée et de la tolérance de l’administration Intra-péritonéale
    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 concerned6
    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
    LVLS
    dernière Visite dernier patient
    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 months5
    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: 47
    F.1.3Elderly (>=65 years) No
    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 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 state47
    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)
    No specific procedures out of usual recommendations
    Pas de procédures spécifiques en dehors des recommandations habituelles
    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 Decision2017-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-14
    P. End of Trial
    P.End of Trial StatusOngoing
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