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    Summary
    EudraCT Number:2018-000655-40
    Sponsor's Protocol Code Number:ACAPP
    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:2021-06-08
    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 number2018-000655-40
    A.3Full title of the trial
    ADJUVANT CAPECITABINE IN HIGH RISK PSEUDOMYXOMA PERITONEI PATIENTS TREATED WITH CYTOREDUCTIVE SURGERY (CRS) AND HYPERTERMIC INTRAPERITONEAL CHEMOTHERAPY (HIPEC)
    CAPECITABINA ADIUVANTE NEI PAZIENTI TRATTATI CON CHIRURGIA CITORIDUTTIVA (CRS) E CHEMIOTERAPIA INTRAPERITONEALE IPERTERMICA (HIPEC) PER PSEUDOMYXOMA PERITONEI AD ALTO RISCHIO DI RECIDIVA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Adjuvant capecitabine in patients with early diagnosis of pseudomyxoma peritonei (PMP), who underwent cytoreductive surgery (CRS) and intraperitoneal hyperthermic chemotherapy (HIPEC).
    Capecitabina adiuvante nei pazienti con prima diagnosi di pseudomyxoma peritonei (PMP), sottoposti a chirurgia citoriduttiva (CRS) e chemioterapia ipertermica intraperitoneale (HIPEC).
    A.3.2Name or abbreviated title of the trial where available
    ACAPP
    ACAPP
    A.4.1Sponsor's protocol code numberACAPP
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00000000
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    A.5.4Other Identifiers
    Name:ACAPPNumber:ADJUVANT CAPECITABINE PSEUDOMYXOMA PERITONEI
    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 SponsorFONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
    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 supportAIRC
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Istituto Nazionale dei Tumori, Milano
    B.5.2Functional name of contact pointClinical Trial Center
    B.5.3 Address:
    B.5.3.1Street Addressvia G. Venezian, 1
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number02/23903818
    B.5.5Fax number02/23903991
    B.5.6E-mailtrialcenter@istitutotumori.mi.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 CAPECITABINA ACCORD - 500 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/PVDC/ALU) - 120X1 COMPRESSE (DOSE UNITARIA)
    D.2.1.1.2Name of the Marketing Authorisation holderACCORD HEALTHCARE LIMITED
    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 nameCapecitabina
    D.3.4Pharmaceutical form Film-coated 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 INNCAPECITABINA
    D.3.9.1CAS number 154361-50-9
    D.3.9.2Current sponsor codeCapecitabina
    D.3.9.3Other descriptive nameCapecitabine
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    PMP PSEUDOMYXOMA PERITONEI
    PMP PSEUDOMYXOMA PERITONEI
    E.1.1.1Medical condition in easily understood language
    PMP PSEUDOMYXOMA PERITONEI, characterized by mucinous tumors in the abdomen and in the pelvis
    PMP Pseudomyxoma del peritoneo,caratterizzato da tumori mucinosi nell'Addome e nel Bacino
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10061269
    E.1.2Term Malignant peritoneal neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of postoperative capecitabine in terms of progression free survival (PFS) after Cytoreduction CRS and HIPEC in PMP patients with KRAS mutated .
    Valutare l¿efficacia, in termini di sopravvivenza libera da progressione (PFS), della capecitabina adiuvante nei pazienti affetti da Pseudomyxoma Peritonei (PMP) con presenza di mutazione del gene KRAS e sottoposti a CRS e HIPEC.
    E.2.2Secondary objectives of the trial
    1.To assess the efficacy of adjuvant capecitabine treatment in terms of overall survival (OS) and disease specific survival (DSS).
    2.To evaluate the feasibility and safety of the capecitabine administered in patients previously treated with CRS and HIPEC
    1.Valutare l¿efficacia della capecitabina adiuvante in termini di sopravvivenza globale (OS) e sopravvivenza malattia specifica (DSS).
    2.Valutare la fattibilit¿ e la tollerabilit¿ del trattamento con capecitabina somministrata a pazienti precedentemente sottoposti a CRS e HIPEC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histological diagnosis of pseudomyxoma peritonei (PMP)
    2.Assessment of KRAS mutation on surgical sample
    3. Patients submitted to a complete cytoreductive surgery and HIPEC for PMP
    4. Age >= 18 years and <76 years
    5.Performance Status (ECOG <2)
    6.Adequate organ function including the following:
    Adequate bone marrow reserve: WBC count >3.0x109/L, absolute neutrophyl count >1.5x109/L, platelet count >100x109/L, and hemoglobin >10 g/dL
    Hepatic: bilirubin < 1.5 times the ULN, alkaline phosphatase, aspartate transaminase, and alanine transaminase < 2.5 xULN
    Renal: Creatinine clearance >50 mL/min or serum creatinine 1.5 x UNL
    7. Patients compliance and geographic proximity that allows for adequate follow-up
    8. Patients must sign an informed consent document (ICD)
    9. Male and female patients with reproductive potential must use an approved contraceptive method.
    1.diagnosi istologica di pseudomyxoma peritonei (PMP)
    2.diagnosi di mutazione del gene KRAS.
    3.pazienti sottoposti a Chirurgia di citoriduzione completa e chemioipertermia intraperitoneale (HIPEC).
    4. Età >= 18 anni e <76 anni
    5.Performance Status (ECOG) < 2
    6.Buona riserva funzionale degli organi valutata secondo i seguenti parametri:
    leucociti >3.0x109/L, neutrofili >1.5x109/L, piastrini >100x109/L, e emoglobina >10 g/dL.
    Enzime epatiche: bilirubina < 1.5 volte il limite superiore del valore di riferimento (ULN), fosfatasi alcalina, ALT e AST < 2.5 x ULN.
    Creatinine clearance >50 mL/min o creatinina sierica 1.5 x ULN.
    7.Una adeguata compliance del paziente e prossimità geografica che consenta un follow-up consistente.
    8.Firma del consenso informato
    9. I pazienti in età riproduttiva devono utilizzare metodi contraccettivi approvati.
    E.4Principal exclusion criteria
    1.Previous systemic chemotherapy and/or biological therapy
    2.Administration of other experimental drugs during the study
    3.Pregnancy and breast-feeding
    4. Serious or uncontrolled medical pathologies or active infections that would jeopardize the possibility of receiving the investigated treatment
    5.Disorders that could influence the absorption of capecitabine (e.g. malabsorption), intestinal occlusion, Crohn's disease or ulcerative colitis
    6.Psychiatric disorders, neurologic disease or other conditions that would make it impossible to comply with the protocol procedures
    7. Positive anamnesis with regard to other neoplastic diseases except for the ones that have been cured for more than 5 years
    1.chemioterapia o terapia biologica previa;
    2. somministrazione di altri terapie oncologiche sperimentali durante il periodo dello studio;
    3. gravidanza o allattamento;
    4. comorbilità severa o infezioni attive che possano compromettere la continuità del trattamento in studio;
    5.condizioni che possano compromettere l’assorbimento della capecitabina come l’occlusione intestinale, morbo di Crohn o colite ulcerativa;
    6. malattie psichiatrica, neurologica o di altra natura che possano impossibilitare le procedure previste dal protocollo;
    7. anamnesi positiva per altre patologie neoplastiche eccetti i casi controllati senza evidenza di recidiva da più di cinque anni.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS)
    Sopravvivenza libera da Progressione (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS will be measured from the date of randomization to the date of radiological / clinical progression of the disease or death (depending on what occurs first)
    La PFS sarà misurata dalla data di randomizzazione alla data di progressione radiologica/clinica della malattia o alla morte ( a seconda di ciò che si verifica prima)
    E.5.2Secondary end point(s)
    Overall Survival
    Sopravvivenza Globale
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall Survival will be measured from the date of randomization to the date of death
    La Sopravvivenza globale sar¿ misurata dalla data di randomizzazione alla data di morte
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Intervento chirurgico di chirurgia citoriduttiva (CRS), associato a infusione di chemioterapia iper
    Cytoreductive surgery (CRS), associated with intraperitoneal hyperthermic chemotherapy infusion (HI
    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.8.5.1Number of sites anticipated in the EEA1
    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
    LVLS
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    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: 17
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 28
    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)
    At the end of the treatment the patients will be in a follow-up period of 2 years
    Al termine del trattamento i pazienti entreranno in un periodo di Follow Up della durata di 2 anni
    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 Decision2018-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-20
    P. End of Trial
    P.End of Trial StatusOngoing
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