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    Summary
    EudraCT Number:2010-022810-26
    Sponsor's Protocol Code Number:PERCAT01 Version 10, 31.01.2011
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-04
    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 ConcernedGermany - PEI
    A.2EudraCT number2010-022810-26
    A.3Full title of the trial
    MULTICENTER, OPEN-LABEL PHASE II STUDY TO EVALUATE THE EFFICACY OF A 2-CYCLE IMMUNOTHERAPY WITH THE TRI FUNCTIONAL BISPECIFIC ANTIBODY CATUMAXOMAB (ANTI EPCAM X ANTI-CD3) IN ADDITION TO SYSTEMIC CHEMOTHERAPY IN PATIENTS WITH PERITONEAL CARCINOMATOSIS FROM GASTRIC OR COLORECTAL ADENOCARCINOMA
    A.3.2Name or abbreviated title of the trial where available
    PERCAT
    A.4.1Sponsor's protocol code numberPERCAT01 Version 10, 31.01.2011
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Witten/Herdecke
    B.1.3.4CountryGermany
    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 organisation
    B.5.2Functional name of contact point
    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 Removab (Catumaxomab)
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Biotech GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameRemovab
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNCatumaxomab
    D.3.9.1CAS number 509077-98-9
    D.3.9.3Other descriptive nameintact, trifunctional monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeintact, trifunctional monoclonal antibody consisting of a mouse immunoglobulin G (IgG) 2a part and a rat IgG2b part
    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 FROM GASTRIC OR COLORECTAL ADENOCARCINOMA
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10068069
    E.1.2Term Peritoneal carcinomatosis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10052360
    E.1.2Term Colorectal adenocarcinoma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10017758
    E.1.2Term Gastric cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Decrease of the incidence of clinically significant malignant ascites (defined by one paracentesis of > 1500 ml or a cumulative amount of 1500 ml by multiple paracentesis within 10 days) from 40% (estimated value from the literature) to 15% within 9 months after first catumaxomab therapy. The event will be counted on the day of 2nd paracentesis

    • Decrease of the incidence of intestinal obstruction with the indication of surgery or parenteral nutrition (> 14 days, > 70% of calorie intake) from to 40% (estimated value from literature and local database) to 20 % within 9 months after first Catumaxomab therapy

    • Decrease of the incidence of ECOG deterioration from ECOG 1 or 2 to ECOG 3 in within 9 months after first Catumaxomab therapy

    • decrease of the incidence of death from 60 % to 35% within 9 months after first Catumaxomab therapy
    E.2.2Secondary objectives of the trial
    Safety endpoints:

    - medical incidence to terminate catumaxomab infusion
    - Frequency, relationship and intensity of clinically relevant grade III and IV adverse events (AEs)


    Immunological endpoints:
    − Quality and Quantity of EpCAM-expression on PC samples
    − Incidence and quality of EpCAM positive Tumor cells in intraperitoneal lavage specimen
    − Disseminated tumor cells and tumor stem cells in peripheral blood during therapy
    − Proportion and absolute numbers of leukocytes (T-cells, B-cells, NK cells, macrophages) in peripheral blood
    − Anti-EpCAM and anti-HER2/neu humoral immune response
    − VEGF levels during therapy
    − Induction of human anti-mouse antibodies (HAMA)
    − Pharmakokinetics: Systemic levels of catumaxomab after i.p. therapy
    −
    − Blood samples and tissue samples will be asservated for future anaylsis. Informed consent for storage of the samples will be mandatorily obtained from every involved patient.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed and dated informed consent
    • Age  18 years
    • Patient is suffering from EPCAM-positive peritoneal carcinoma-tosis of colorectal or gastric adenocarcinoma, which was con-firmed by histological analysis.
    • ECOG status 1 or 2 (Karnofsky index  70)
    • Patient is not eligible for surgical cytoreduction followed by hy-perthermic intraperitoneal chemotherapy (see Attachments for selection criteria).
    • Patient is eligible for FOLFOX or FOLFIRI treatment in case of colorectal cancer; patient is eligible for FLO or FLOT treatment in case of gastric cancer (i.e. no intolerance or hypersensitivity, no tumor progression during treatment)
    • Body mass index > 17
    E.4Principal exclusion criteria
    • Symptomatic ascites (estimated accumulation of more than 1500 ml by sonography and computer tomography and punc-ture of more than 1500 ml)
    • Ileus or abdominal obstruction with the need of surgical inter-vention at inclusion or parenteral feeding (> 30% of daily calo-rie intake)
    • Previous use of non-humanized monoclonal mouse or rat anti-bodies
    • Known or suspected hypersensitivity or allergy to Catu-maxomab or to similar antibodies
    • Presence of any acute or chronic systemic infection
    • Pre-existing heart failure: NYHA class > II
    • Pregnancy or breast feeding
    • Other concurrent uncontrolled medical conditions
    • Previous Catumaxomab therapy
    • Medical or psychiatric conditions that compromise the patient’s ability to give informed consent
    • Inadequate renal function (Creatinine >1,5 x ULN)
    • (PTT) Partial thromboplastine time > x ULN
    • Inadequate hepatic function (AST or ALT > 2.5 x ULN or Bilirubin > 2 x ULN)
    • Inadequate bone marrow function with platelets < 100 000 cells/mm3 or absolute neutrophil count (ANC) < 1500 cells/mm3 or a proportion of < 15% of lymphocytes in differential blood count
    • Pregnant or nursing women, or women of childbearing potential who are not using an effective contraceptive method during the study and at least three months after the last infusion (i.e., oral or injectable contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms)
    • Any further condition which, according to the investigator, re-sults in an undue risk to the patient during participation in the present study
    • Parallel participation in another clinical trial
    • Previous participation in the present study
    • Treatment with another investigational product during this study or during the last 30 days prior to study start (day 0)
    E.5 End points
    E.5.1Primary end point(s)
    Symptom- and progression free survival, defined by the primary end-points:

    • Incidence of clinically significant malignant ascites (defined by one paracentesis of > 1500 ml or a cumulative amount of 1500 ml by multiple paracentesises within 10 days)
    • Incidence of intestinal obstruction with the need of surgical in-tervention or parenteral nutrition (>14 days, > 70% of calorie intake)
    • Increase from ECOG 1 or 2 to ECOG 3
    • Death

    Each parameter will be analyzed separately with reference to previous patient data. The first day of cumulative ascites paracentesis or intestinal obstruction and parenteral nutrition will be assessed.
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunological response
    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 Yes
    E.8.1.7.1Other trial design description
    Control: Historical Data from patients treated traditionally
    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
    Control: Historical Data from patients treated traditionally
    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 concerned7
    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
    EOT is defined as Dday 270.
    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 years0
    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.1.3Elderly (>=65 years) Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 40
    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 Decision2011-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-16
    P. End of Trial
    P.End of Trial StatusCompleted
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