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    Summary
    EudraCT Number:2020-000560-37
    Sponsor's Protocol Code Number:IOV-CAR-01-2020PIPAC
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-10-21
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-000560-37
    A.3Full title of the trial
    Pressurized intraperitoneal aerosol chemotherapy in patients with peritoneal carcinomatosis. PIPAC-IOV study. Single-center, single-arm open-label phase II clinical trial
    Chemioterapia intraperitoneale nebulizzata e pressurizzata in pazienti con carcinosi peritoneale. Studio PIPAC-IOV. Trial clinico di fase due monocentrico, in aperto a singolo braccio
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot study on intraperitoneal chemotherapy delivered via aerosol in patients with peritoneal carcinomatosis
    Studio pilota sulla chemioterapia intraperitoneale somministrata tramite aerosol in pazienti con carcinosi peritoneale
    A.3.2Name or abbreviated title of the trial where available
    IOV-CAR-01-2020 PIPAC
    IOV-CAR-01-2020 PIPAC
    A.4.1Sponsor's protocol code numberIOV-CAR-01-2020PIPAC
    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 SponsorISTITUTO ONCOLOGICO VENETO - IRCCS
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Oncologico Veneto
    B.5.2Functional name of contact pointUnità Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Gattamelata 64
    B.5.3.2Town/ cityPadova
    B.5.3.3Post code35131
    B.5.3.4CountryItaly
    B.5.4Telephone number0498215704
    B.5.5Fax number0498215706
    B.5.6E-mailclinical.trial@iov.veneto.it
    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 doxorubicina
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameDoxorubicin
    D.3.2Product code [L01DB01]
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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.3.9.1CAS number 25316-40-9
    D.3.9.2Current sponsor code25316-40-9
    D.3.9.3Other descriptive nameDOXORUBICIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB01827MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name cisplatino
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namecisplatino
    D.3.2Product code [L01XA01]
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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.3.9.1CAS number 15663-27-1
    D.3.9.2Current sponsor code15663-27-1
    D.3.9.3Other descriptive nameciplatinum
    D.3.9.4EV Substance CodeDB00515
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 3
    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.2.5The 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 nameOxaliplatino
    D.3.2Product code [L01XA03]
    D.3.4Pharmaceutical form Concentrate for solution for 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 INNOXALIPLATINO
    D.3.9.1CAS number 61825-94-3
    D.3.9.2Current sponsor code61825-94-3
    D.3.9.3Other descriptive name[SP-4-2-(1R-trans)]-(1,2-cyclohexanediamine-N,N')[ethanedioato(2-)-O,O']platinum
    D.3.9.4EV Substance CodeSUB09490MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Peritoneal carcinomatosis
    Carcinosi peritoneale
    E.1.1.1Medical condition in easily understood language
    Metastases to the peritoneum
    Metastasi al peritoneo
    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 10068069
    E.1.2Term Peritoneal carcinomatosis
    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
    The main objective of the study is to determine the effectiveness of PIPAC technique in patients with peritoneal metastases, who are not eligible for curative surgical resection.
    Verificare l'attività della tecnica PIPAC in pazienti con metastasi peritoneali che non sono candidabili alla resezione chirurgica con intento curativo
    E.2.2Secondary objectives of the trial
    Secondary aims are to determine
    - the feasibility of the study treatment
    - the safety of the PIPAC technique
    - the antineoplastic activity
    - preliminary data on progression free survival (PFS) and overall survival (OS)
    - the quality of life (HRQoL)
    Obbiettivi secondari sono determinare:
    - la fattibilità del trattamento
    - la sicurezza della tecnica PIPAC
    - l'attività antineoplastica
    - dati preliminari sulla progressione libera da malattia e sulla sopravvivenza complessiva
    - l'andamento della qualità della vita correlata alla salute
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female = 18 years of age
    - ECOG performance status 0–2.
    - Histologically or cytologically documented gastrointestinal or ovarian cancer (based on tissue from the primary tumor and/or its metastases); other cancer can be included based on a careful multidisciplinary assessment of the risk benefit of the procedure in the specific patient
    - Radiological, histological or cytological evidence of peritoneal metastases
    - Not eligible for curative surgery and/or HIPEC according to National Guidelines
    - ife expectancy of at least 24 weeks;
    - Laboratory Requirements:
    - Neutrophils = 1.5 x 109/L;
    - Platelets = 100 x 109/L;
    - Hemoglobin = 9 g/dL;
    - Total bilirubin = 1.5 time the upper-normal limits (UNL) of the normal values and ASAT (SGOT) and/or ALAT (SGPT) = 2.5 x UNL;
    - Alkaline phosphatase = 2.5 x UNL;
    - Creatinine clearance = 30 mL/min according to the Cockcroft-Gault formula or serum creatinine =1.5 x UNL;
    - Negative serum or urine pregnancy test at screening for women of childbearing potential. Female subjects, or male subjects with female partners of child-bearing potential must be willing to use highly effective contraception as approved by the investigator (i.e. barrier contraceptive measure or oral contraception, total abstinence) during the study and until 30 days after last study treatment;
    - Written informed consent to the study participation according to the Local Ethic Committee requirements before any study procedure;
    - Will and ability to comply with the protocol.
    - soggetti adulti (età maggiore di 18 anni) di sesso maschile o femminile;
    - buon performance status (ECOG 0-2)
    - diagnosi confermata di neoplasia di origine colorettale, gastrica, o ginecologica (ovaio). Altre diagnosi istologiche tra cui pancreato-biliare, uro-genitale, tessuti molli o di altre rare origini potranno essere incluse previa attenta valutazione multidisciplinare del rischio beneficio atteso del trattamento nel singolo caso;
    - evidenza radiologica, istologica o citologica di metastasi peritoneale
    - paziente non candidabile ad intervento di chirurgia citoriduttiva con intento radicale;
    - funzione renale, epatica e midollare compatibile con la procedura PIPAC;
    - donne in età fertile e uomini sessualmente attivi dovranno utilizzare metodi contraccettivi efficaci durante tutto lo studio
    - in grado di comprendere le finalità dello studio e di fornire un valido consenso scritto alla partecipazione dello studio.
    E.4Principal exclusion criteria
    - Any surgery apart from staging laparoscopy less than 4 weeks before inclusion;
    - Extra peritoneal metastasis; patients with limited extra peritoneal metastatic disease can be enrolled based on mdt discussion;
    - Bowel obstruction or parenteral nutrition or gastric tube;
    - A history of allergic reaction or contraindication to platinum containing compounds or doxorubicin;
    - Any significant disease which, in the investigator’s opinion, excludes the patient from the study;
    - Myocardial insufficiency, defined as NYHA class >3
    - Renal impairment, defined as glomerular filtration rate (GFR) < 30 ml/min
    - Impaired liver function defined as bilirubin > 1.5 UNL (except in presence of Gilbert disease)
    - Pregnancy or breastfeeding;
    - Untreated central nervous system disease, history or evidence of thrombotic or hemorrhagic disorders not considered currently in complete remission;
    - Active infection requiring antibiotics;
    - Medical, geographical, sociological, psychological, or legal conditions that would prevent the patient from completing the study or signing the informed consent;
    - paziente sottoposto a chirurgia nelle 4 settimane precedenti all’inclusione nello studio;
    - occlusione intestinale, nutrizione parenterale o sondino nasogastrico;
    - presenza di metastasi extraperitoneali; pazienti con malattia minima extraperitoneale trattabile con intento curativo possono essere inclusi in seguito a valutazione multidisciplinare
    - anamnesi positiva per reazione allergica ai composti del platino o alla doxorubicina
    - trattamenti precedenti con massima dose cumulativa per i chemioterapici in studio
    - insufficienza cardiaca, renale od epatica non controllata dalle terapie farmacologiche in atto;
    - gravidanza;
    - incapacità o mancanza di volontà a dare consenso informato scritto.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the histological response to treatment, assessed using the peritoneal regression grading system (PRGS) score.
    Response to treatment will be assessed comparing the PRGS score at each PIPAC procedure respect to the PRGS score at the first PIPAC procedure (baseline).
    Patients, who did not receive at least three procedures, will be considered non responders.
    The PRGS score distinguishes between four grades of tumor regression, PRGS 1–4. PRGS 1 (complete response) is defined as no tumor cells present; PRGS 2 (major response) is regressive changes predominant over tumor cells; PRGS 3 (minor response) is predominance of tumor cells but regressive changes present, and PRGS 4 (no response) is no regressive changes present.
    At least four peritoneal punch biopsies of 3 to 5mm in diameter should be taken in all four abdominal quadrants, plus a centimetric peritonectomy of not-affected peritoneum (to be used as reference).
    The PRGS score will be reported as the mean and the worst value of the regression grades obtained. When complete tumor response is suspected intraoperatively, a peritoneal cytology should be sampled.
    A histological tumor response is defined as a decrease of 0.5 in the mean PRGS score.
    Tumor response rate is defined as the portion of participants with a histological tumor response.
    Risposta patologica valutata mediante Peritoneal Regression Grading System
    E.5.1.1Timepoint(s) of evaluation of this end point
    At second and third PIPAC procedure after 6 or 8 weeks and 12 or 16 weeks after first PIPAC procedure.
    Alla seconda e terza PIPAC dopo rispettivamente 6-8 e 12-16 settimane dopo l'esecuzione della prima PIPAC
    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 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 No
    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 trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    Last safety visit after the third PIPAC procedure in the last enrolled patient
    Ultima visita di sicurezza dopo terza procedura PIPAC nell'ultimo paziente arruolato.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 25
    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)
    Patients could receive further PIPAC procedures and/or systemic chemotherapy in case of clinical benefit.
    I pazienti potranno essere sottoposti ad ulteriori procedure PIPAC e/o chemioterapia standard in presenza di beneficio clinico.
    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 Decision2020-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-30
    P. End of Trial
    P.End of Trial StatusOngoing
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