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    Summary
    EudraCT Number:2011-001192-39
    Sponsor's Protocol Code Number:P11-1
    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:2012-03-30
    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 number2011-001192-39
    A.3Full title of the trial
    An Open-label Study of Sipuleucel-T in European Men with Metastatic, Castrate Resistant Prostate Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sipuleucel-T Manufacturing Demonstrating Study
    A.3.2Name or abbreviated title of the trial where available
    Sipuleucel-T Manufacturing Demonstration Study, ver .01
    A.4.1Sponsor's protocol code numberP11-1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01477749
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDendreon Corporation
    B.1.3.4CountryUnited States
    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 supportDendreon Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQueen Mary University of London
    B.5.2Functional name of contact pointCentre for Experimental Cancer Medi
    B.5.3 Address:
    B.5.3.1Street AddressLower Ground Floor, Old anatomy Building, Charterhouse Square
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeEC1M 6BQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number004402078828506
    B.5.5Fax number004402078825958
    B.5.6E-maila.pungaliya@qmul.ac.uk
    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 Yes
    D.2.1.1.1Trade name PROVENGE
    D.2.1.1.2Name of the Marketing Authorisation holderDendreon Corporation
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameSipuleucel-T
    D.3.4Pharmaceutical form Dispersion 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.3.8INN - Proposed INNContains Autologus peripheral blood mononuclear cells activated with PAP-GM-CSF including a minimum of 50x10E6 autologus CD54+ cells
    D.3.9.3Other descriptive nameAutologus peripheral blood mononuclear cells activated with PAP-GM-CSF (sipuleucel-T)
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number50000000
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    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
    Advanced prostate cancer that spread beyound the prosatte and no longer responds to hormone therapy
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10036910
    E.1.2Term Prostate cancer NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10066489
    E.1.2Term Progression of prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10036916
    E.1.2Term Prostate cancer stage D
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10062904
    E.1.2Term Hormone-refractory prostate cancer
    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 purpose of the study is to demonstrate that sipuleucel-T can be successfully manufactured at a European manufacturing facility. Sipuleucel-T (Provenge®) is approved for use in the US by the Food and Drug Administration for the treatment of metastatic castrate resistant prostate cancer. The study sponsor, Dendreon Corporation is applying for Manufacturing Authorization in Europe. The intent of this study is to demonstrate that sipuleucel-T manufactured in Europe results in the same cellular activation as seen in sipuleucel-T produced in the US.

    To evaluate successful manufacturing, samples (1-2% of the cells) will be removed from each patient’s immune cell collections before and after they are mixed with the protein. Four immune system tests will be performed on these samples and the results of these tests will be summarized descriptively for comparison to results obtained during clinical studies conducted in the US. These tests indicate if the immune cells are activated su
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the wellbeing of patients being treated with this therapy. Side effects will be carefully recorded.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent obtained prior to the initiation of study procedures.
    2. Males, age ≥ 18 years at the time of registration
    3. Histologically documented adinocarcinoma of the prostate.
    4. Metastatic diseaseas evidenced by soft tissue and/or bony metastases on bone scan and/or computed tomography (CT) scan of the abdomen and pelvis at any time prior to registration. (Subjects whose metastatic disease is detectable only on chest CT scan are not eligible).
    5. Castrate resistant prostate cance, subjects must have current or historical evidence of disease progression concomitant with surgical or medical castration, as demonstrated by PSA progression or progression of measurable diseae or progression of non-measurable disease as defined below:
    - PSA: Two consecutive PSA values, at least 14 days apart, each ≥5.0 ng/mL and ≥ 50% above the minimum PSA observed during castration therapy or above the pre-treatment value if there was no response.
    -Measurable disease: ≥50% increase in the sum of the cross products of all measurable lesions or the development of any new lesions. The change will be measured
    against the best response to castration therapy or against the pre-castration studies if there was no response.
    -Non-measurable disease:
    -Soft tissue disease: the appearance of 1 or more new lesions, and/or unequivocal worsening of non-measurable disease when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response.
    -Bone disease: Apprearance of 2 or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response.Increase uptake of pre-exsisting lesions on bone scan does not constitute progression.

    6. Castration levels of testosterone (≤50ng/dl; ≤1.74 nmol/L) achieved via medical or surgical castration. Surgical castration must have occurred at least 3 months prior to registration. Subjects who are not surgically castrated must be receiving medical castration therapy, have initiated such therapy at least 3 months prior to registration, and continue such therapy during their participation on this study.

    7. Serum PSA ≥ 5.0 µg/L
    8. ECOG performance status ≤1
    9. Adequate hematologic, renal, and liver function as evidenced by the following:

    White blood cell count ≥2,500 cell/µL
    Absolute neutrophil count ≥1000 cell/µL
    Platelet count ≥1000,000 cell/µL
    Hemoglobin ≥10.0g/dL
    Creatinine ≤2.0 mg/dL
    Total Bilirubin ≤2 x Upper limit of normal (ULN)
    Aspartate aminotransferase (AST, SGOT) ≤2.5 x ULN
    Alanine aminotransferase (ALT, SGPT) ≤2.5 x ULN


    10. Negative Serology tests indicating no active infection with human immunodeficiency virus types 1 and 2 (HIV -1/2), human T cell lymphotrophic virus types 1 and 2 (HTLV –I/II), and Hepatitis B and C viruses.
    E.4Principal exclusion criteria
    1. The presence of known brain metastases. In the case of suspected or questionable findings, the Investigator must address each findings in the subject’s medical record prior to registration

    2. A requirement for systemic immunosuppressive therapy for any reason.

    3. Treatment with any investigational vaccine within 2 years prior to registration

    4. Any previous treatment with sipuleucel-T

    5. Any previous treatment with ipilimumab (Yervoy, MDX-010, or MDX-101) or denosumab (Xgeva).

    6. Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography >50%), or spinal cord compression.

    7. Subject with known malignancies other than prostate cancer that are likely to require treatment within 6 months of registration.


    8. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or GM-CSF.

    9. More than 2 chemo regimens to any time prior to registration

    10. Treatment with any of the following medicated or interventions within 28 days of registration:

    -Systemic corticosteroids; use of inhaled, intranasal, intra-articular, and topical steroids is acceptable, as is a short course (i.e. < 1 day) of corticosteroids to prevent a reaction to the IV contract used for CT scans.

    -Non-steroidal anti-androgens (e.g., bicalutamide, flutamide, or nilutamide).

    -External beam radiation therapy or major surgery requiring general anesthetic.

    -Any other systemic therapy for porstate cancer including secondary hormonal therapies, such as mogestrol acetate (Megace), diethylstilbestrol (Des), and ketoconazole, medical castration therapy is not exclusionary

    -Immunosuppressive therapy

    -Treatment with any other investigational product

    11. Any injection requiring pareteral antibiotic therapy or causing fever (temp >100.5 °F or 38.1°C) within 7 days prior to registration.

    12. Any medical intervention or other condicition which, in the opinion of the Investigator or the Dendreon Medical Monitor, could compromise adherence, with study requirements or otherwise compromise the study’s objectives.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measures of the study are assays that evaluate the immune response generated by sipuleucel-T. These measures include CD54+ cell count, CD54 up-regulation, total nucleated cell count, and product viability. The results of these assays will be summarized descriptively for comparison to results obtained in clinical studies conducted in the United States and will be used to determine if sipuleucel-T can be effectively produced to the same high standard in Europe as in the United States.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Samples will be collected before and after manufacture of every sipuleucel-T dose
    E.5.2Secondary end point(s)
    Safety will be assessed by summarising adverse events, laboratory test results, vital sign measurements, ECOG performance status, and physical examination findings
    E.5.2.1Timepoint(s) of evaluation of this end point
    adverse events are solicited at every subject visit and are also documented if reported in between visits

    routine laboratory (safety labs) test are collected at screening and at 30 day post infusion visit for lab and PE visit.

    Physical examination, vital sign measurements, ECOG performance status are performed at screening, up to 7 days before the 2nd and 3rd leukapheresis procedures, and at the study completion visit.

    Visit signs are also collected 30 minutes before the infusion starts and 30 minutes after the infusion ends.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Scope of the trial is to demonstrate sipuleucel-T can be made at an EU manufacturer
    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 No
    E.8.1.2Open No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 No
    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
    LVLS
    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 months9
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 60
    F.4.2.2In the whole clinical trial 60
    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)
    Sipuleucel-T treatment consists of three infusions. No additional treatments are typically given, therefore, no provision has been made to provide further treatment with sipuleucel-T to participants of this clinical study when the research has finished. The patient's medical oncologist will discuss any further treatment options with them.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-10
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