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    Summary
    EudraCT Number:2006-002801-30
    Sponsor's Protocol Code Number:ABA-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-03-10
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2006-002801-30
    A.3Full title of the trial
    "Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo del tratamiento de mantenimiento con ABAGOVOMAB en pacientes con cáncer epitelial de ovario después de una respuesta completa a la quimioterapia de primera línea"

    A RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTRE TRIAL OF ABAGOVOMAB MAINTENANCE THERAPY IN PATIENTS WITH EPITHELIAL OVARIAN CANCER AFTER COMPLETE RESPONSE TO FIRST LINE CHEMOTHERAPY
    A.4.1Sponsor's protocol code numberABA-01
    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 SponsorMENARINI RICERCHE S.p.A
    B.1.3.4CountryItaly
    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/3/03/155
    D.3 Description of the IMP
    D.3.1Product nameAbagovomab
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAbagovomab
    D.3.9.1CAS number 792921-10-9
    D.3.9.2Current sponsor codeMEN2234
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) Yes
    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 Information not present in EudraCT
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    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.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the benefit in terms of recurrence free survival (RFS) of Abagovomab vs placebo as maintenance therapy after clinical complete response to debulking surgery and standard platinum/taxane 1st line chemotherapy.
    E.2.2Secondary objectives of the trial
    1)To compare the effect of Abagovomab vs placebo in terms of overall survival(OS)
    2)To evaluate the safety and tolerability of repeated doses of Abagovomab
    3)To evaluate the time course of immune response induced by repeated doses of Abagovomab, namely induction of Ab3 and HAMA
    4)To evaluate in a subset of approximately 10% of patients additional immunologic parameters (i.e. Ab1 and CA125-specific T cell response)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At a maximum of 12 weeks after the last cycle of 1st line IV or IP standard platinum/taxane chemotherapy,patients must fulfill all the following inclusion criteria to be eligible for entry in to study;
    1)Age ≥ 18 years;
    2)Properly executed written informed consent;
    3)History of histological and CA125 (>35 U/ml) confirmed diagnosis of stage III-IV epithelial ovarian,fallopian tube,or primary peritoneal cancer;
    4)History of debulking surgery and of 6-8 cycles of standard platinum/taxane based non-investigational IV/IP chemotherapy;
    5)Complete clinical response defined as:
    - Normal Physical examination;
    - No symptoms suggestive of persistent cancer;
    - No definite evidence of disease by computed tomography (CT) of the abdomen and pelvis within the previous 4 weeks;
    - Negative chest x-ray (or chest CT scan) within the previous 4 weeks;
    - Serum CA 125 level within normal laboratory range.
    6)Adequate haematologic, renal and hepatic function:
    - ANC ≥ 1.5 x 10(9)/l;
    - Platelets ≥ 75 x 10(9)/l;
    - Haemoglobin ≥ 6.2 mmol/l (≥ 9.9 mg/dl);
    - Serum creatinine ≤ 1.5 x ULN;
    - Bilirubin ≤ 1.5 x ULN; AST, ALT, AP ≤ 2.5 x ULN.
    7)ECOG performance status (PS) ≤ 2.
    E.4Principal exclusion criteria
    Patients are ineligible to participate in the study, if any of the following criteria are present:
    1)Any other invasive malignancies, with the exception of non-melanoma skin cancer or cervical carcinoma in situ, within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy;
    2)Known active autoimmune disease requiring chronic treatment with immunosuppressive agents(e.g. rheumatoid arthritis, ulcerative colitis,etc.);
    3)Known immune deficiency (e.g. HIV,hypogammaglobulinemia,etc.);
    4)Known infection with hepatitis B, or hepatitis C;
    5)History of recent myocardial infarction (≤ 6 months) or decompensated heart failure(NYHA class ≥ III);
    6)Previous or concomitant use of any anti-cancer therapy other than the platinum-taxane 1st line chemotherapy; any maintenance or cosolidation therapy is not permitted after completion of standard front-line chemotherapy.
    7)Concomitant use of any other Investigational agent;
    8)Any prior investigational anti-cancer vaccine or monoclonal antibody;
    9)Known allergy to murine proteins;
    10)Any significant medical or psychiatric condition, drug or alcohol abuse that might prevent the patient from complying with all study procedures;
    11)Clinically significant active infection;
    12)Concomiant use of any immunosuppresive agent (e.g., steroids, cyclosporin, etc.);
    13)Major surgery within the previous 2 weeks;
    14)Radiotherapy within the previous 4 weeks;
    15)Any significant toxicity from prior chemotherapy;
    16)Unreliability or inability to follow protocol requirements
    E.5 End points
    E.5.1Primary end point(s)
    Recurrence Free Survival (i.e. time from the date of randomization to documentation of disease recurrence or death from any cause).
    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 No
    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) Yes
    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 Yes
    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 Yes
    E.8.2.3Other No
    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 concerned19
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA124
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Treatment will end 21 months from the randomization of the last patient, and the DBO period will end 12 weeks after the last administered dose, i.e. 24 months from the randomization of the last patient. At that time all patients on study will undergo a final study visit. Survival status will continue to be followed (open) up to 5 years after the end of DBO period.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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 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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 620
    F.4.2.2In the whole clinical trial 870
    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)
    Patients will receive the expected normal treatment for 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 Decision2007-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-30
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