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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
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    The EU Clinical Trials Register currently displays   41501   clinical trials with a EudraCT protocol, of which   6826   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Summary
    EudraCT Number:2006-004484-54
    Sponsor's Protocol Code Number:IP-CAT-OC-02
    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:2007-05-22
    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 number2006-004484-54
    A.3Full title of the trial
    Multicenter, single-arm, phase II study of the tri functional antibody catumaxomab (anti EpCAM x anti-CD3) administered intra- and postoperatively in patients with epithelial ovarian cancer
    A.3.2Name or abbreviated title of the trial where available
    n.a.
    A.4.1Sponsor's protocol code numberIP-CAT-OC-02
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbern.a.
    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 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 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 No
    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/3/04/193
    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 Information not present in EudraCT
    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) 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 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
    Epithelial Ovarian Cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10033162
    E.1.2Term Ovarian epithelial cancer stage II
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10033163
    E.1.2Term Ovarian epithelial cancer stage III
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10033164
    E.1.2Term Ovarian epithelial cancer stage IV
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10033161
    E.1.2Term Ovarian epithelial cancer stage I
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determination of the safety of an adjuvant treatment with catumaxomab in patients with epithelial ovarian cancer in terms of post-operative complication rate.
    E.2.2Secondary objectives of the trial
    Determination of further safety data within the study period as well as efficacy data collected during post study follow-up.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated informed consent form before any protocol-specific screening
    procedures
    2. Patient has a primary diagnosis of an epithelial ovarian cancer including clear cell
    carcinoma (FIGO IA(G2-G3) – IV) (histologically confirmed)
    3. Karnofsky index > = 70
    4. Female at an age of 18 years or older
    5. Negative pregnancy test result at screening in women of childbearing potential
    (applies to patients without documented menopause or sterility)

    E.4Principal exclusion criteria
    1. Exposure to prior cancer therapy (surgery, investigational product-, chemo- or
    radio-therapy) specific for ovarian cancer
    2. Previous treatment with non-humanized mouse or rat monoclonal antibodies
    3. Known/suspected hypersensitivity to catumaxomab or similar antibodies
    4. Second malignancy within the last 5 years (if directly influencing patient's overall
    prognosis)
    5. Presence of constant immunosuppressive therapy
    6. Presence of symptomatic heart failure or occlusive arterial diseases
    7. Inadequate renal function (creatinine >1.5 x ULN)
    8. Inadequate hepatic function (AST or ALT > 2.5 x ULN or bilirubin ≥ 1.5 x ULN)
    9. Platelets <100.000 cells/mm3; absolute neutrophil count <1500 cells/mm3
    10. Presence of any acute or chronic systemic infection
    11. Presence of complete bowel obstruction
    12. Presence of symptomatic brain metastases
    13. Inadequate respiratory function in the opinion of the investigator
    14. Any further condition which, according to the opinion of the investigator, results
    in an undue risk of the patient by participating in the present study
    15. Parallel participation in another clinical trial or previous participation in this study
    16. Pregnant or nursing women, or women with childbearing potential who are not
    using an effective contraceptive method during the study and for at least 3
    months after the last infusion

    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is 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:

    • Surgical untoward event
    o Any fistula
    o Ileus requiring any surgical therapy
    o Bowel perforation
    o Anastomosis insufficiency requiring surgery
    o Wound infection
    o Hemorrhage requiring any therapy
    o Septicemia

    • Non-surgical untoward event
    o Thromboembolism verified by at least one of the following objective diagnostic
    measures:
    - Positive V/Q scan (“high probability” according to PIOPED-criteria)
    - Angiography
    - CT-scan
    o Infection ≥ CTC Grade 3
    o Pleural effusion requiring puncture
    o Renal insufficiency ≥ CTC Grade 3
    o Liver failure ≥ CTC Grade 3
    o Heart rhythm disorder requiring intervention
    o Neurological disorder ≥ CTC Grade 3
    o Pulmonary edema

    • Death, as an outcome of an event with fatal result

    With regard to postoperative complications a study specific DSMB will evaluate all patients in a timely manner, as there is a significant frequency of complications due to the surgical procedure alone. The DSMB will be organised by sponsor's Drug Safety and Pharmacovigilance Department, similar to the general catumaxomab DSMB using the same procedures and workflows.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    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 months8
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 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 41
    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 Decision2007-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-08-08
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