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    Summary
    EudraCT Number:2010-024111-13
    Sponsor's Protocol Code Number:AIO-STO-0110
    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:2011-02-01
    Trial results View 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 number2010-024111-13
    A.3Full title of the trial
    Explorative trial to investigate catumaxomab (anti-EpCAM x anti-CD3) for treatment of peritoneal carcinomatosis in patients with gastric adenocarcinomas prior to gastrectomy

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Explorative trial to investigate catumaxomab (antibody) for treatment of peritoneal carcinomatosis in patients with gastric cancer prior to surgery (resection)
    A.3.2Name or abbreviated title of the trial where available
    Catumaxomab for peritoneal carcinomatosis in gastric cancer
    A.4.1Sponsor's protocol code numberAIO-STO-0110
    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 SponsorAIO-Studien-gGmbH
    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 supportFresenius Biotech GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWiSP GmbH
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressKarl-Benz-Str. 1
    B.5.3.2Town/ cityLangenfeld
    B.5.3.3Post code40764
    B.5.3.4CountryGermany
    B.5.4Telephone number492173853130
    B.5.5Fax number4921738531311
    B.5.6E-mailinfo@wisp.de
    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
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Biotech GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    D.3.11 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) 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 Yes
    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 typeAntibody developed by hybridoma method
    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
    Gastric adenocarcinoma and carcinoma of the esophago-gastric junction (type II and type III according to Siewert’s classification) prior to gastrectomy, with peritoneal carcinomatosis.
    E.1.1.1Medical condition in easily understood language
    patients with gastric cancer and surface dissemination(s) of the abdominal cavity (peritoneal carcinomatosis)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10017758
    E.1.2Term Gastric cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10015362
    E.1.2Term Esophageal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10068069
    E.1.2Term Peritoneal carcinomatosis
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 this trial is to investigate the efficacy of catumaxomab by determination of the rate of macroscopic complete remissions of peritoneal carcinomatosis after treatment with one cycle (four doses) of catumaxomab followed by six cycles of fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) chemotherapy. The primary endpoint is the rate of macroscopic complete remissions of peritoneal carcinomatosis at the second diagnostic laparoscopy or laparotomy.
    E.2.2Secondary objectives of the trial
    Secondary endpoints to be analyzed in both study arms, (including exploratory comparisons) are:
    • Surgical resection rate (R0, R1, R2)
    • Overall survival (OS)
    • Disease-free survival (DFS)
    • Progression-free survival (PFS)
    • Immunoreaction against tumor in tissue samples
    • Detection of disseminated tumor cells via PCR
    • Frequency, relationship, and severity/seriousness of AEs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients treated in this trial must fulfil all of the following inclusion criteria:
    • Histologically confirmed diagnosis of resectable gastric adenocarcinoma or adenocarcinoma of the esophagogastric junction (type II and type III according to Siewert’s classification)
    • Macroscopic peritoneal carcinomatosis (stage P1-4 according to Gilly et al., appendix 1)
    • Patients potentially eligible for gastrectomy after primary systemic (and intraperitoneal) treatment
    • Signed and dated informed consent before the start of specific protocol procedures.
    • Age > 18 years
    • ECOG Performance Status of 0 or 1
    • Life expectancy of at least 12 weeks.
    • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
    - Hemoglobin > 10.0 g/dl
    - Leukocyte count >4.000/µl; absolute neutrophil count (ANC) >2.000/µl
    - Platelet count >= 100.000/μl
    - Total bilirubin < 1,5 times the upper limit of normal
    - ALT and AST < 3 x upper limit of normal
    - Alkaline phosphatase < 5 x ULN
    - Serum creatinine < 1.5 x upper limit of normal and creatinine clearance > 60 ml/min.
    • The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.
    E.4Principal exclusion criteria
    Patients with any of the following characteristics do not qualify for the study:
    • Distant metastasis other than peritoneal seedings
    • Prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry
    • Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrolment
    • History of HIV infection or chronic hepatitis B or C
    • Active, clinically serious infections (> grade 2 NCI-CTC version 3.0)
    • Pre-existing neuropathy > grade 1 (NCI CTCAE), except for loss of tendon reflex
    • Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
    • History of organ allograft
    • Patients undergoing renal dialysis
    • Known hypersensitivity to any of the drugs given in the study; known hypersensitivity to murine (rat and/or mouse) proteins.
    • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
    Excluded therapies and medications, previous and concomitant:
    • Prior anti-cancer chemotherapy or immunotherapy.
    • Investigational drug therapy outside of this trial during or within 4 weeks of study entry
    • Major surgery within 4 weeks of starting the study, and patients must have recovered from effects of major surgery
    • Pregnant or breast-feeding patients, or planning to become pregnant within 6 months after the end of treatment. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and for 6 months after the end of treatment.
    • Substance abuse, medical, psychological or social conditions that may interfere with the patient’s understanding of the informed consent procedure, participation in the study or evaluation of the study results.
    E.5 End points
    E.5.1Primary end point(s)
    Macroscopic complete remission (CR) of peritoneal carcinomatosis is the primary endpoint of the study and defined as the disappearance of any malignant peritoneal lesions, according to diagnostic laparoscopy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of neo-adjuvant treatment (aprox. 140 (investigative arm ) /115 (comparative arm) days)
    E.5.2Secondary end point(s)
    Surgical resection rate (R0,R1,R2), Overall survival (OS), Disease-free survival (DFS), Progression free survival (PFS), Immunoreaction against tumor in tissue samples, Detection of disseminated tumor cells via PCR, Toxicity/safety
    E.5.2.1Timepoint(s) of evaluation of this end point
    DFS, PFS, OS on event
    Immunoreaction/PCR on remission evaluation
    Toxicity/safety after end of therapy
    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 Yes
    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 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
    standard therapy with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT)
    E.8.2.4Number of treatment arms in the trial2
    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 concerned17
    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 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
    End of the trial is the last visit of the last subject undergoing the trial.
    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 months2
    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.1.2.1Number of subjects for this age range: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    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 state42
    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)
    Cf. section 6.4 of the protocol.
    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 Decision2011-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-15
    P. End of Trial
    P.End of Trial StatusCompleted
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