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    Summary
    EudraCT Number:2006-005704-13
    Sponsor's Protocol Code Number:CO328X05
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-03-28
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-005704-13
    A.3Full title of the trial
    A Phase II Study of Intravenous CNTO328 in Patients with Recurrent Epithelial Ovarian Cancer
    A.3.2Name or abbreviated title of the trial where available
    CNTO328 in ovarian cancer
    A.4.1Sponsor's protocol code numberCO328X05
    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 SponsorQueen Mary, University of London
    B.1.3.4CountryUnited Kingdom
    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 No
    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 nameCNTO328
    D.3.2Product code CNTO328
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeCNTO328
    D.3.9.3Other descriptive namechimeric murine human anti-IL-6 monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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 typeMonoclonal antibody
    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
    This is a Phase II trial to determine the efficacy of intravenous CNTO 328 in women with the following diseases:
    recurrent epithelial ovarian cancer, Fallopian tube carcinoma, primary peritoneal carcinoma of serous, endometrioid or clear cell sub-types.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10066697
    E.1.2Term Ovarian cancer recurrent
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine efficacy of intravenous CNTO 328 in women with recurrent epithelial ovarian cancer.
    E.2.2Secondary objectives of the trial
    a) To determine changes in Quality of Life in patients with recurrent epithelial ovarian cancer following treatment with CNTO328.
    b) To determine the neutralisation of IL-6 in tumour, blood and ascitic specimens following treatment with CNTO328.
    c) To determine the alterations in inflammatory markers in blood, ascitic fluid and tumour tissue (where possible) following intravenous delivery of CNTO 328 in recurrent epithelial ovarian cancer and determine whether any of these biomarkers are predictive of response.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Women with recurrent histologically confirmed ovarian carcinoma, Fallopian tube carcinoma, or primary peritoneal carcinoma of serous, endometrioid or clear cell sub-types.
    • Previous treatment with no more than three platinum-containing chemotherapy regimes.
    • Patients are also eligible if they have relapsed within six months of completing first line platinum-containing chemotherapy or have experienced documented progression whilst receiving first-line platinum-containing chemotherapy
    • Life expectancy of at least 3 months
    • Age ≥ 18 years
    • WHO performance status of 0, 1 or 2
    • Patients must have the following clinical laboratory values:
    Granulocyte count > 1.0 x 109/l
    Platelet count > 100 x 109/l
    Hb > 9.0 g/dl
    Serum creatinine < 1.5 x Upper Limit of Normal (ULN)
    Bilirubin < 30 µmol/l
    Albumin > 30 g/dl
    Prothrombin and activated partial thromboplastin times < 1.5 x ULN
    Alk Phos < 5 x ULN
    E.4Principal exclusion criteria
    • Tumours of malignant mixed mesodermal (MMMT) or mucinous types.
    • Unresolved bowel obstruction
    • Prior administration of or hypersensitivity to humanised monoclonal antibodies
    • Chemotherapy within the preceding 3 weeks
    • Radiotherapy within the preceding 3 weeks
    • Treatment with any investigational agent within the preceding 4 weeks or within 5 half-lives of the investigational agent, whichever is longer.
    Known leptomeningeal involvement
    • Pregnant or lactating females.
    • Inability or unwillingness to give informed consent.
    • Ongoing active infection or a documented history of HIV infection, Hepatitis B or C.
    • Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease (Appendix 7).
    • Concurrent autoimmune disorder, e.g. systemic lupus or any demyelinating disease.
    • No corticosteroids to be taken within the preceding 4 weeks
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be any response (SD, PR or CR) in any of the patients. All patients will be staged with conventional (CT) imaging prior to treatment, after 5 treatments and every 3 months until end of treatment, to assess disease response to CNTO 328. Measurable disease in the CT component will be assessed by modified RECIST criteria.. CA-125 will also be measured at enrolment, prior to each infusion and at the end treatment. CA-125 responses will also be assessed according to the criteria of the GCIG and correlated to the CT response. Patients will additionally be investigated with [18F]-FDG PET scan imaging. The FDG-PET responses will be assessed according to the criteria of Avril et al.
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    The entire trial will be stopped when:

    • The drug is considered too toxic to continue treatment prior to the required number of patients being recruited
    • The total number of patients to be recruited (20) is reached.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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 be followed for 4 weeks after the last administration of the study drug. If there are events that occurred while the patient was on study which are attributed to the study drug, the patient will be followed monthly afterwards until resolution of these events, unless the patient starts another anti-tumour 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 Decision2007-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-09-01
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