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    Summary
    EudraCT Number:2006-005766-39
    Sponsor's Protocol Code Number:C1034T08
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-03-27
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2006-005766-39
    A.3Full title of the trial
    A Randomized, Double-blind, Multicenter, Phase 2 Study of a Human Monoclonal Antibody to Human aV Integrins (CNTO 95) in Combination With Docetaxel and Prednisone for the First-Line Treatment of Subjects With Metastatic Hormone Refractory prostate Cancer
    A.4.1Sponsor's protocol code numberC1034T08
    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 nameCNTO 95
    D.3.2Product code CNTO 95, C1034 (cell line)
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeCNTO 95
    D.3.9.3Other descriptive nameCNTO 95 IgG; Human monoclonal antibody to Human Anti-Integrin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hormone refractory prostate cancer (HRPC)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10062904
    E.1.2Term Hormone-refractory prostate cancer
    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 objectives of this study are to evaluate the efficacy and safety of treatment with CNTO 95 in combination with docetaxel and prednisone compared with docetaxel and prednisone without CNTO 95 in subjects with metastatic HRPC.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to evaluate the effect of docetaxel and prednisone with or without CNTO 95 on αv integrin-signaling pharmacodynamic biomarkers in blood, pain intensity and response/progression, overall prostate cancer symptom benefit, and the population PK of CNTO 95 in subjects with metastatic HRPC.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The substudy will take place in the US only.
    E.3Principal inclusion criteria
    1. Are male ≥ 18 years of age.

    2. Have histologically or cytologically confirmed adenocarcinoma of the prostate.

    3. Have radiologic or clinical evidence of metastatic disease.

    4. Have progressive hormone-refractory disease after orchiectomy or gonadotropin-releasing hormone analog and/or antiandrogen treatment within 6 months prior to the first study agent administration, documented by at least 1 of the following:
    a. Transaxial imaging (CT or MRI) tumor progression
    b. Rise in 2 consecutive PSA values obtained 14 days apart
    c. Radionucleotide bone scan with at least 2 new lesions

    5. Have an ECOG score ≤ 2.

    6. Have adequate bone marrow, liver, and renal function, defined as follows:
    a. Absolute neutrophil count (ANC) ≥ 1.5 x 10(9)/L
    b. Hemoglobin ≥10 g/dL (without transfusion)
    c. Platelets ≥ 100 x 10(9)/L
    d. AST and ALT < 2.5 x ULN
    e. Alkaline phosphatase < 5 x ULN
    f. Total bilirubin within normal limits
    g. Creatinine ≤ 1.5 mg/dL
    h. Activated partial thromboplastin time (aPTT) and prothrombin time (PT) ≤ 1.5 x ULN

    7. Have testosterone < 50 ng/mL for subjects without surgical castration. Testosterone level will not be documented for subjects who have been surgically castrated.

    8. Have serum PSA ≥5.0 ng/mL.

    9. Have a life expectancy > 12 weeks.

    10. Have at least 4 weeks from previous major surgery to date of first study agent administration. Subjects must have recovered or stabilized from previous surgery.

    11. Have discontinued flutamide > 4 weeks prior to the first study agent administration, or have discontinued nilutamide or biclutamide > 6 weeks prior to the first study agent administration.

    12. Use appropriate contraception (eg, condom) for the duration of the study and for 3 months after the last study treatment.

    13. Provide signed and dated informed consent(s) prior to any study-specific procedures and agree to comply with all protocol-specified procedures.
    E.4Principal exclusion criteria
    1. Have known CNS metastases.

    2. Had prior systemic nonhormonal therapy for HRPC.

    3. Received any investigational drug/agent within 30 days or 5 half-lives, whichever is longer.

    4. Had a prior malignancy (other than prostate cancer) except for adequately treated superficial bladder cancer, basal cell or squamous cell carcinoma of the skin, or other cancer for which the subject has been disease-free for ≥ 5 years.

    5. Have known HIV seropositivity or known hepatitis B or C infection.

    6. Have planned major surgery during the study.

    7. Had prior radiotherapy to > 25% of the marrow-containing skeleton.

    8. Have peripheral neuropathy > Grade 1.

    9. Have a history of uveitis.

    10. Have taken any over-the-counter or herbal treatment for prostate cancer within 4 weeks prior to the first study agent administration.

    11. Have a serious concurrent illness or significant cardiac disease characterized by significant ischemic coronary disease, significant arrhythmias (requiring active treatment), or congestive heart failure (≥ NYHA II) or myocardial infarction within the previous 6 months.

    12. Have any uncontrolled medical condition, serious infection, or the presence of clinically significant laboratory abnormalities that places the subject at unacceptable risk by participating in the study or confounds the ability to interpret data from the study.

    13. Requires hematopoietic growth factors or transfusion of blood products to meet eligibility criteria.

    14. Had prior use of radionucleotide therapy (eg, Strontium(89), Samarium).

    15. Undergoing concurrent immunotherapy, biotherapy, radiotherapy, investigational therapy, or steroid therapy other than that included in this protocol (except for topical or inhaled steroids, or unless clinically indicated [eg, for reactions to IV contrast, allergic reactions that develop during the study, severe nausea, vomiting]).

    16. Requires concurrent anticoagulation therapy (except for low-dose prophylaxis).

    17. Have known hypersensitivity to docetaxel or its components.

    18. Have a history of anaphylaxis or severe allergic reaction(s) to human Ig therapy or polysorbate 80 (formulation components of CNTO 95).

    19. Has history of bleeding diathesis.

    20. Had recurrent arterial or venous thromboembolism within 6 months preceding enrollment.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is progression-free survival (PFS), defined as the time from the date of randomization until the first documented sign of disease progression (radiographic, clinical, or both) or death due to any cause, whichever occurs sooner.
    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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 last follow-up visit among all treated subjects.
    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 months5
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days17
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 120
    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)
    At the end of 8 cycles of study treatment, subjects who are responding to treatment with SD or better (as defined in Section 9.1.1 of the protocol) are eligible to receive an additional 6 months (8 cycles) of extended treatment. If a subject continues to benefit from treatment (with SD, PR, or CR) after receiving 6 months of extended treatment, continued treatment may be discussed with Centocor.
    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 Decision2007-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-12-18
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