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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   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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    EudraCT Number:2009-011251-48
    Sponsor's Protocol Code Number:CNTO888PCR2001
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-08-13
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-011251-48
    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 Metastatic Castrate-Resistant Prostate
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study where CNTO888 (an anti-CCL2 Monoclonal Antibody) is used to treat subjects with Metastatic Castrate-Resistant Prostate Cancer.
    A.4.1Sponsor's protocol code numberCNTO888PCR2001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00992186
    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 SponsorJanssen Biologics B.V.
    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 supportOrtho Biotech Oncology R&D, unit of centocor Research & Development Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressEinsteinweg 101
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CB
    B.5.4Telephone number+31715242166
    B.5.5Fax number+31715242110
    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 No
    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) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    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. 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
    Metastatic Castrate-Resistant Prostate Cancer
    E.1.1.1Medical condition in easily understood language
    Prostate Cancer
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 is to determine the composite response (measured by change from baseline in skeletal lesions, extra-skeletal lesions, and PSA values) in subjects with metastatic CRPC 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 are to evaluate further clinical and additional biological activity of single-agent CNTO 888 in subjects with metastatic CRPC, including the following endpoints:
    • Objective response rate (complete response [CR] +PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
    • Progression-free survival (PFS)
    • Overall survival (OS)
    • PSA response
    • Urinary crosslinked N-telopeptide of type I collagen (NTX) response
    • Pain response
    • Safety profile
    • Biological activity (defined by changes in macrophage infiltration, monocyte subsets M1/M2, CCL2 levels in tumor, blood, and serum and urinary bone markers)
    • Pharmacokinetics
    • Pharmacodynamics
    • Antibodies to CNTO 888 to CNTO 888
    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:
    • Male 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 adenocarcinoma of the prostate
    • Received at least 1 but no more than 2 prior docetaxel-based chemotherapy regimens and had disease progression following the last therapy. Disease progression is defined as:
    – Serum PSA progression, defined as a rise in at least 2 consecutive serum PSA values, each obtained at least 1 week apart, and within 4 weeks prior to first dose of study agent (see Attachment 4)
    – Radiologic disease progression: If disease progression is shown by bone scan only, then disease progression is defined by the appearance of 2 or more new bone lesions
    • Serum PSA ≥ 5.0 ng/mL within 4 weeks prior to the first dose of study agent
    • Orchiectomy or testosterone < 50 ng/dL by means of pharmacological/chemical castration within 4 weeks prior to the first dose of study agent
    • At least 6 weeks from prior docetaxel chemotherapy regimen to first dose of study agent
    • ECOG performance status score of ≤ 2 (see Attachment 3)
    • 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
    • Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 6 months after receiving the last dose of study drug.
    • 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:

    • Experiences a hormonal treatment withdrawal response (including a lowering of PSA that was previously rising or symptomatic improvement)
    • Known or symptomatic CNS metastases
    • 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
    • Vaccinated with live, attenuated vaccines within 4 weeks prior to the first dose of study agent. Inactivated, injectable or inhaled influenza vaccine is permitted
    • Bleeding diathesis
    • Requires concurrent therapeutic dose of anticoagulation (low-dose prophylaxis is permitted)
    • Bisphosphonate therapy initiated < 6 weeks prior to the first dose of study agent or that required dose adjustment during this time
    • Treatment with systemic cancer therapy, herbal treatments, over-the-counter treatments for prostate cancer, or local radiotherapy within 4 weeks prior to the first dose of study agent
    – Palliative radiotherapy (eg, for pain, fracture prevention) to control a small area of metastatic bone disease may be permitted if the subject has recovered from the effects of the radiotherapy

    • Received an investigational drug/agent (including vaccines) 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 (except for topical or inhaled steroids, or unless clinically indicated [eg, for asthmatic attacks, reactions to IV contrast, allergic reactions that develop during the study, severe nausea, vomiting]). The following exceptions apply:
    – Subjects on stable doses of steroids for treatment of noncancerous conditions will be allowed to continue on the steroid therapy during the study only if maintained at the same dose (ie, the dose may not be increased during this study).
    – Luteinizing Hormone Releasing Hormone (LHRH) is permitted provided the subject is on a stable dose prior to screening
    • Prior use of radionucleotide therapy (eg, Strontium89, Samarium)
    • Use of disallowed therapies: Non-steroidal antiandrogens (flutamide, bicalutamide, or nilutamide) or other hormonal treatments (such as estramustine or ketoconazole), within 6 weeks prior to the first dose of study agent or as concomitant medication
    • 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, or currently receiving treatment for an infection
    • Major surgery 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
    • 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
    • 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 6)
    • Known to be seropositive for HIV, or known active hepatitis A, B, or C infection
    • 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 prostate cancer) except adequately treated basal cell or squamous cell carcinoma of the skin, or other cancer for which the subject has been disease-free for ≥ 5 years
    • Any condition 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
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the composite response rate, measured by change from baseline in skeletal lesions, extra-skeletal lesions, and PSA values. 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 criteria
    • PSA response at 12 weeks and the absence of skeletal and extra-skeletal progression
    • Stable disease at 24 weeks defined as the absence of PSA, skeletal, or extra-skeletal progression
    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 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. 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.8.4.1Number 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 EEA14
    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 the last study assessment for the last subject on study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days9
    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 No
    F.2.2Male Yes
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 43
    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 Decision2009-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-06
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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