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    Summary
    EudraCT Number:2015-000418-23
    Sponsor's Protocol Code Number:AGO/2015/002
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-06-04
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-000418-23
    A.3Full title of the trial
    Intraoperative intraperitoneal chemoperfusion to treat peritoneal minimal residual disease in stage III ovarian cancer: a randomized phase II trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intraoperatieve intraperitoneale Chemoperfusie voor de behandeling van minimale residuele ziekte bij stadium III Eierstokkanker: een gerandomiseerde fase II studie.
    A.4.1Sponsor's protocol code numberAGO/2015/002
    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 SponsorGhent University Hospital
    B.1.3.4CountryBelgium
    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 supportGhent University Hospital
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGhent University Hospital
    B.5.2Functional name of contact pointBimetra Clinics
    B.5.3 Address:
    B.5.3.1Street AddressDe Pintelaan 185
    B.5.3.2Town/ cityGhent
    B.5.3.3Post code9000
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3293320500
    B.5.5Fax number+3293320520
    B.5.6E-mailbimetra.clinics@uzgent.be
    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 Cisplatin Hospira
    D.2.1.1.2Name of the Marketing Authorisation holderHospira Benelux BVBA
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameCisplatine Hospira
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNCisplatine Hospira
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number75 to 100
    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.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 Physioneal
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter S.A.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 namePhysioneal 35 Glucose 1.36%
    D.3.4Pharmaceutical form Solution for peritoneal dialysis
    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 INNGlucosemonohydraat
    D.3.9.3Other descriptive nameGLUCOSE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB13983MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNatriumchloride
    D.3.9.3Other descriptive nameSODIUM CHLORIDE SOLUTION 0.9%
    D.3.9.4EV Substance CodeSUB20079
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.67
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcalciumchloridedihydraat
    D.3.9.3Other descriptive nameCALCIUM CHLORIDE DIHYDRATE
    D.3.9.4EV Substance CodeSUB12664MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.257
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmagnesiumchloridehexahydraat
    D.3.9.3Other descriptive nameMAGNESIUM CHLORIDE HEXAHYDRATE
    D.3.9.4EV Substance CodeSUB12526MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.051
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnatriumbicarbonaat
    D.3.9.1CAS number 144-55-8
    D.3.9.3Other descriptive nameSODIUM HYDROGEN CARBONATE
    D.3.9.4EV Substance CodeSUB12290MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNatrium-(S)-lactaatoplossing
    D.3.9.3Other descriptive nameSODIUM LACTATE
    D.3.9.4EV Substance CodeSUB15300MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.12
    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
    stage III ovarian cancer
    E.1.1.1Medical condition in easily understood language
    stage III ovarian cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the effect of cytoreductive surgery (CRS) and efficacy of cisplatin-based intraoperative intraperitoneal chemoperfusion (IPEC) in patients with primary or recurrent serous epithelial ovarian cancer (OC), in order to treat peritoneal minimal residual disease (pMRD).
    E.2.2Secondary objectives of the trial
    To study the pharmacodynamics of IP drug delivery and the value of hyperthermic administration.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Tumor type
    o Biopsy proven serous epithelial ovarian carcinoma or peritoneal carcinoma
     Primary or recurrent disease
     Extent of disease
    o Positive retroperitoneal lymph nodes and /or microscopic metastasis beyond the pelvis (FIGO stage III)
    o Stage IV with unilateral pleural fluid allowed
    o Complete or nearly complete macroscopic cytoreduction at the time of surgery (CC-0 or CC-1) deemed possible based on imaging, laparoscopy, or both
     Second-line patients; platinum sensitive
     Age over 18 years
     No major cardiac or respiratory disease
     Absent or limited (<500ml) clinical ascites
     Adequate performance status (Karnofsky index > 70%)
     Adequate mental faculty, allowing to understand the proposed treatment protocol and provide informed consent
     Expected life expectancy more than 6 months
     Laboratory data
    o Serum creatinine  1.5 mg/dl or a calculated GFR (CKD-EPI) ≥ 60 mL/min/1.73 m2
    o Serum total bilirubin  1.5 mg/dl, except for known Gilbert’s disease
    o Platelet count > 100.000/µl
    o Hemoglobin > 9g/dl
    o Neutrophil granulocytes > 1.500/ml
    o International Normalized Ratio (INR)  2
     Absence of alcohol and/or drug abuse
     No other concurrent malignant disease
     No inclusion in other clinical trials interfering with the study protocol
     No concurrent chronic systemic immune or hormone therapy, except neoadjuvant chemotherapy
     Absence of any severe organ insufficiency
     No pregnancy or breast feeding
     Written informed consent
    E.4Principal exclusion criteria
     Severe or uncontrolled cardiac insufficiency, including recent (< 6 months) occurrence of myocardial infarction, the presence of congestive cardiac insufficiency, of symptomatic angor in spite of optimal medical care, of cardiac arrhythmia requiring medical treatment presenting insufficient rhythm control, or uncontrolled arterial hypertension
     Pregnancy or breast feeding
     Platinum resistant (relapse > 12 months after completion of Pt containing therapy) or refractory disease
     Active bacterial, viral or fungal infection
     Active gastro-duodenal ulcer
     Parenchymal liver disease (any stage cirrhosis)
     Uncontrolled diabetes mellitus
     Severe obstructive or restrictive respiratory insufficiency
     Psychiatric pathology capable of affecting comprehension and judgment faculty
     Tumor in the presence of obstruction
     Evidence of extra-abdominal disease (with the exception of unilateral malignant pleural effusion) or extensive liver metastasis
     Peritoneal cancer index (sPCI) ≥ 25
    E.5 End points
    E.5.1Primary end point(s)
    Tissue penetration distance of cisplatin in peritoneal tumor tissue nodules
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of surgery
    E.5.2Secondary end point(s)
    o Postoperative morbidity and mortality
    o Quality of Life
    o Pharmacokinetics of cisplatin in peritoneal perfusate and plasma samples
    o Pharmacodynamics: Pt DNA adduct formation
    o Overall survival, disease free survival, peritoneal recurrence free survival
    o Effects of (H)IPEC on peritoneal cytology
    o Translational research: analyzing gene expression of selected biomarkers for Pt sensitivity, stromal density and composition of tumor slices.
    E.5.2.1Timepoint(s) of evaluation of this end point
    o Postoperative morbidity and mortality: 30 days after debulking
    o Quality of Life: preoperatively, after 6 weeks and after 3, 6, 12, 18 and 24 months.
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned4
    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 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
    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 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: 50
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 10
    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 state60
    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 treatment of the condition
    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 Decision2015-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-18
    P. End of Trial
    P.End of Trial StatusOngoing
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