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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-002727-16
    Sponsor's Protocol Code Number:IP-CAT-GC-03
    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:2006-11-01
    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 number2006-002727-16
    A.3Full title of the trial
    Multicenter, open-label phase II study to evaluate the safety and efficacy of the tri-functional bispecific antibody catumaxomab (anti-EpCAM x anti-CD3) in patients with gastric adenocarcinoma after neoadjuvant chemotherapy and intended curative resection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the safety, tolerability and feasibility regarding specific postoperative complications after intraoperative treatment with catumaxomab
    subsequent to a neoadjuvant chemotherapy and curative tumor resection
    A.3.2Name or abbreviated title of the trial where available
    n.a.
    A.4.1Sponsor's protocol code numberIP-CAT-GC-03
    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 SponsorFresenius Biotech GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 organisationFresenius Biotech GmbH
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Ring 193a
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code80807
    B.5.3.4CountryGermany
    B.5.4Telephone number+498930659311
    B.5.6E-mailmed.info@fresenius-biotech.com
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/06/414
    D.3 Description of the IMP
    D.3.1Product namecatumaxomab (INN)
    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 INNcatumaxomab
    D.3.9.1CAS number 509077-98-9
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 Yes
    D.3.11.13.1Other medicinal product typeAntibody developed by hybridoma method
    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 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/06/414
    D.3 Description of the IMP
    D.3.1Product namecatumaxomab (INN)
    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 INNcatumaxomab
    D.3.9.1CAS number 509077-98-9
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 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 Neoplasm malignant
    E.1.1.1Medical condition in easily understood language
    Gastric cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level HLT
    E.1.2Classification code 10017812
    E.1.2Term Gastric neoplasms malignant
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary evaluation of the safety, tolerability and feasibility regarding specific
    postoperative complications of an adjuvant treatment with catumaxomab administered after curative tumor resection subsequent to a neoadjuvant
    chemotherapy. Relevant efficacy parameters (e.g., DFS, OS) will be assessed
    during a post-treatment follow-up period of two years.
    E.2.2Secondary objectives of the trial
    Secondary safety endpoints:
    − Frequency, relationship and seriousness of adverse events (AEs)
    − Clinically relevant laboratory results (hematology with differential blood
    count, clinical chemistry, coagulation tests and determination of cytokines,
    procalcitonin, and anti-catumaxomab antibodies by DABA)
    − Vital functions (SBP/DBP, HR, T°)
    Efficacy endpoints:
    − Surgical resection rate
    − Chemotherapeutic response rate (using the RECIST-guidance)
    − Overall survival (OS) defined as the time from study enrolment until death
    − Disease-free survival (DFS) defined as the time from study enrolment to the point of diagnosis of recurrent disease or death, whatever occurred first
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated informed consent
    2. Male or female patient at an age of 18 years or older
    3. Patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3)
    4. TNM-staging at screening of T2/T3/T4, N+/-, M0
    5. Intended curative subtotal or total gastrectomy ('en-bloc'-R0-resection considering the standard D2-scheme)
    6. Karnofsky index >= 70
    7. Negative pregnancy blood test at screening but not more than 72 hours prior to the start of chemotherapy, for women of childbearing potential
    E.4Principal exclusion criteria
    1. Exposure to prior cancer therapy (surgery, chemo- or radio-therapy) or planned adjuvant chemo- or radiotherapy of the current gastric cancer before "End-of-Treatment" visit (EOT = 1 month after last catumaxomab administration)
    2. Prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry (except cervix carcinoma in situ and adequately treated non-melanomatous skin cancer)
    3. Previous use of non-humanized monoclonal mouse or rat antibodies
    4. Known or suspected hypersensitivity or allergy to catumaxomab or to similar antibodies or to any of the planned ECX chemotherapeutic drugs
    5. Known dihydropyrimidine-dehydrogenase (DPDH) deficiency
    6. Known contraindications to any of the planned ECX-chemotherapeutics
    7. Presence of distant metastases
    8. Presence of constant immunosuppressive therapy
    9. Presence of bilateral pleural effusion or hypalbuminemia associated with hypovolemia and hypotension
    10. Presence of symptomatic pyloric stenosis (defined as excessive vomiting and weight loss > 10% within the last 3 months)
    11. Presence of any acute or chronic systemic infection
    12. Presence of a bowel obstruction within the last 30 days
    13. Pre-existing heart failure > NYHA class II
    14. Inadequate renal function (Creatinine >1.5 x ULN or Creatinine Clearance < 60 ml/min/kg according to the Cockroft Formula)
    15. Inadequate hepatic function (AST or ALT > 2.5 x ULN or Bilirubin > 1.5 x ULN)
    16. Inadequate bone marrow function with Platelets < 100 000 cells/mm3 or absolute neutrophil count (ANC) < 1500 cells/mm3
    17. Left ventricular ejection fraction (LVEF) below normal institutional ranges as measured by echocardiogram or any clinically significant abnormality detected by echocardiogram
    18. Pregnant or nursing woman, or woman of childbearing potential who is not using an adequate and effective contraceptive method during the study and at least three months after the last i.p.-infusion (i.e., oral or injectable contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms)
    19. Any further condition which according to the investigator results in an undue risk to the patient during participation in the present study
    20. The patient planned to be enrolled is an employee of any involved study investigator or of any involved institution including the study sponsor
    21. Parallel participation in another clinical trial or previously in this study
    22. Treatment with another investigational product during this study or during the last 30 days prior to study start
    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoint will be the rate of all specific postoperative complications newly observed during a period of 30 days after surgery in those study patients who received at least one dose of catumaxomab.
    The events below will be regarded as specific postoperative complications:
    - Any death
    - Any abscess requiring an intervention (e.g., surgery or drainage)
    - Symptomatic cholecystitis verified by ultrasound or CT-scan
    - Symptomatic pancreatitis verified by CT-scan and at least one of the following objective diagnostic measurements/measures:
    - Serum amylase > = 3 x ULN
    - Serum lipase > = 3 x ULN
    - Pulmonary infection verified by chest X-ray or CT-scan
    - Abdominal hemorrhage requiring any therapy
    - Anastomosis insufficiency requiring surgery
    - Ileus with grade IV clinical symptoms or requiring any surgical therapy
    - Thromboembolism verified by at least one of the following objective diagnostic
    measures:
    - Positive V/Q scan ('high probability' according to PIOPED-criteria22)
    - Angiography
    - CT-scan
    The assessment on the postoperative complications by documentation of the postoperative outcome will be performed by the local investigator based on the clinical symptoms observed after surgery.
    E.5.1.1Timepoint(s) of evaluation of this end point
    All specific postoperative complications newly observed during a period of 30 days after surgery in those study patients who received at least one dose of catumaxomab.
    E.5.2Secondary end point(s)
    Safety endpoints:
    - Frequency, relationship and seriousness of adverse events (AEs).
    - Clinically relevant laboratory results (hematology with differential blood count, clinical chemistry, coagulation tests and determination of cytokines, procalcitonin, and anti-catumaxomab antibodies by DABA)
    - Vital functions (SBP/DBP, HR, T°)
    Efficacy endpoints:
    - Surgical resection rate
    - Chemotherapeutic response rate (using the RECIST-guidance)
    - Overall survival (OS)
    - Disease-free survival (DFS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety: All AEs until EOT.
    Labaratory results:
    Pre-treatment at screening, pre-infusion of the day of surgery and of the postoperative days 7, 10, 13 and 16 prior to i.p.-infusion.
    Vital functions:
    Pre-treatment at screening, pre-infusion of the day of surgery prior to operation and of the postoperative days 7, 10, 13 and 16 prior to the i.p.-infusion.
    Efficacy endpoints:
    - Overall survival (OS) at 3, 6, 9, 12, 18 and 24 months after EOT, time from study enrolment until death
    - Disease-free survival (DFS) at 3, 6, 9, 12, 18 and 24 months after EOT, time from study enrolment to the point of diagnosis of recurrent disease or death, whichever occurred first
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Russian Federation
    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
    Last follow-up contact
    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 months6
    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 months6
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 70
    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
    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 Decision2006-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-06
    P. End of Trial
    P.End of Trial StatusCompleted
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