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    Summary
    EudraCT Number:2009-011250-17
    Sponsor's Protocol Code Number:CNTO888OVC2001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-06-04
    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 number2009-011250-17
    A.3Full title of the trial
    An Open-label, Multicenter, Phase 2 Study of Single-agent CNTO 888 (an anti- CCL2 Monoclonal Antibody) for the Treatment of Subjects with Recurrent Ovarian Cancer
    A.4.1Sponsor's protocol code numberCNTO888OVC2001
    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 SponsorCentocor B.V.
    B.1.3.4CountryNetherlands
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCNTO888
    D.3.2Product code CNTO888
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeCNTO 888
    D.3.9.3Other descriptive nameanti-CCL2 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 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) 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
    recurrent Ovarian cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    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
    The primary objective of the study is to determine the composite response (measured by best overall response [CR + PR] or PFS at 24 weeks) in subjects with recurrent ovarian cancer who receive single-agent 15 mg/kg CNTO 888 IV formulation administered as a 90-minute infusion once every 2 weeks.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to evaluate safety and additional efficacy (objective response rate [CR + PR], PFS, CA 125 response rate, and overall survival), pharmacology (pharmacokinetics and pharmacodynamics), and immunogenicity of single-agent CNTO 888 in subjects with recurrent ovarian cancer.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Potential subjects must satisfy all of the following criteria to be enrolled in the study:
    • Women age ≥ 18 years
    • Sign an informed consent document indicating that they understand the purpose of
    and procedures required for the study and are willing to participate in the study
    • Histological documentation of epithelial ovarian or Fallopian tube cancer, or
    primary peritoneal cancer of serous, endometrioid, or clear cell subtypes
    • Received at least 1 prior complete 6-cycle platinum-containing chemotherapy
    regimen and no more than 3 regimens of chemotherapy in total
    • Recurrence or progression after platinum-based treatment for ovarian cancer
    defined according to the following subsets:
    − Group A: Relapse-free interval after all prior platinum-based treatment of
    > 6 months and who are not candidates for further platinum therapy due to a
    hypersensitivity to platinum or for other reasons
    − Group B: Relapse-free interval after the first or any subsequent platinumbased
    treatment of < 6 months
    • Measurable disease at baseline according to RECIST guidelines
    • Subjects in Group B must be willing and able to have pretreatment and
    posttreatment biopsies (see Section 4.4)
    • ECOG performance status during screening and immediately prior to the first dose
    of study agent: (Attachment 3)
    − Status of 0, 1, or 2 for subjects who have had only 1 prior chemotherapy
    regimen
    − Status of 0 or 1 for subjects who have had more than 1 chemotherapy prior
    regimen
    • Adequate bone marrow, liver, and renal function within 2 weeks prior to the first
    dose of study agent as described below:
    − Hemoglobin ≥ 9.0 g/dL (5.6 mmol/L; 90 g/L) without transfusion
    dependency or erythropoiesis-stimulating agents
    − Absolute neutrophil count (ANC) ≥ 1.0 x 109/L (1000/mm3) without
    hematopoietic cytokine support
    − Platelets ≥ 100 x 109/L (100,000/mm3) without transfusion dependency or
    hematopoietic cytokine support
    − Coagulation prothrombin time (PT) or international normalized ratio (INR),
    and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
    − AST and ALT ≤ 3 x ULN if no liver metastasis; ≤ 5 x ULN with liver
    metastasis
    − Total bilirubin ≤ 1.5 x ULN
    − Serum creatinine ≤ 1.5 x ULN
    • Female subjects must be postmenopausal (at least 12 months since last menses),
    surgically sterile, abstinent, or if sexually active and of child-bearing potential be
    practicing an effective method of birth control (e.g., prescription or oral
    contraceptives, contraceptive injections, intrauterine device, double-barrier method,
    contraceptive patch, male partner sterilization) before study entry and throughout
    the study; have a negative urine pregnancy test at screening.
    • Willing/able to adhere to the prohibitions and restrictions specified in this protocol
    • To participate in the optional pharmacogenomic component of this study, subjects
    must have signed the informed consent form for pharmacogenomic research
    indicating willingness to participate in the pharmacogenomic component of the
    study (where local regulations permit). Refusal to give consent for this component
    does not exclude a subject from participation in the clinical study.
    E.4Principal exclusion criteria
    Potential subjects who meet any of the following criteria will be excluded from
    participating in the study:
    • Tumors of malignant mixed mesodermal types or primary mucinous tumors of the
    ovary
    • Subjects who have refractory disease (relapsed disease during any prior platinumbased
    chemotherapy regimen)
    • Subjects with a relapse-free interval of > 12 months after the most recent platinumbased
    treatment
    • Known or symptomatic CNS metastases
    • Requires parenteral hydration or nutrition; has evidence of bowel obstruction; a
    history of abdominal fistula, gastrointestinal perforation or bleeding, or intra-abdominal abscess
    • Presence of or at high risk for intestinal obstruction by, or transluminal intestinal
    growth of, ovarian cancer or any concurrent malignancy
    • Residual toxicities resulting from previous therapy that are ≥ Grade 2 (except for
    alopecia)
    • Known allergies, hypersensitivity, or intolerance to CNTO 888 or its excipients
    (refer to Section 14.1, Physical Description of Study Drug) or clinically significant
    reactions to chimeric or human proteins
    • Bleeding diathesis or requires concurrent therapeutic dose of anticoagulation (lowdose
    prophylaxis is permitted to maintain IV line patency)
    • Received an investigational drug/agent (including vaccines), intraperitoneal cancer
    therapy, local radiotherapy or used an investigational medical device within
    4 weeks prior to the first dose of study agent or are currently enrolled in an
    investigational study
    • Concomitant treatment such as, immunotherapy, biotherapy, radiotherapy,
    chemotherapy, investigative therapy, or new steroid therapy (see Section 8 for more
    details)
    • Requires transfusion of blood products to meet eligibility criteria, or within
    4 weeks prior to the collection of screening hematology laboratory sample
    • Uncontrolled infection, clinically important active infection within 4 weeks prior to
    the first dose of study agent, currently receiving treatment for an infection, known
    to be seropositive for HIV, or known active hepatitis A, B, or C infection
    • Major surgery, medical or surgical interference with the peritoneum or pleura or
    significant traumatic injury within 4 weeks prior to the first dose of study agent, or
    planning to have surgery (except for minor surgical procedures) during the study,
    or planned major surgery within 8 weeks after the last dose of study agent.
    Laparoscopy is allowed.
    • Serious concurrent illness (medical or psychiatric), altered mental status (eg,
    dementia) or any uncontrolled medical condition (eg, uncontrolled diabetes),
    including the presence of laboratory abnormalities, that places the subject at
    unacceptable risk by participating in the study, limits full compliance, or confounds
    the ability to interpret data from the study or that, in the opinion of the investigator,
    would compromise the well-being of the subject or the study or prevent the subject
    from meeting or performing study requirements
    • Subjects on antiplatelet therapy who have a bare metal or drug-eluting coronary
    stent or with active angina pectoris or New York Heart Association (NYHA) Class
    III or IV heart disease. Significant cardiac disease characterized by significant
    ischemic coronary disease, significant arrhythmias, or congestive heart failure
    (greater than or equal to NYHA Class II) or myocardial infarction within 6 months
    prior to the first dose of study agent (see Attachment 4)
    • Transplanted solid organ and receiving immunosuppressive therapy (with the
    exception of a corneal transplant that was performed ≥ 12 weeks prior to screening)
    • Active or symptomatic autoimmune disorders or requiring treatment within the last
    5 years (eg, rheumatoid arthritis, Crohn’s disease, systemic lupus, or multiple
    sclerosis)
    • Prior or concomitant malignancy (other than ovarian cancer) except adequately
    treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the
    cervix, or other cancer for which the subject has been disease-free for ≥ 5 years or
    prior treatment with a platinum-based therapy for a non-ovarian cancer indication
    • Pregnant or breast-feeding
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the composite response rate. The composite response rate will be estimated and its 2-sided exact 95% confidence interval will be computed. A subject has a composite response if 1 of the following responses occurs after the first dose of study agent:
    • CR or PR according to RECIST guidelines
    • Disease has not progressed at 24 weeks according to RECIST guidelines
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    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 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.8.5The trial involves multiple Member States Yes
    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
    The end of study is defined as 1 year after the last subject on study receives the last CNTO 888 treatment.
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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.1.3Elderly (>=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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 80
    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)
    Not different then normal, 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 Decision2010-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-07-14
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