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    The EU Clinical Trials Register currently displays   35464   clinical trials with a EudraCT protocol, of which   5825   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2004-000299-15
    Sponsor's Protocol Code Number:BC1-03
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2004-07-12
    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 ConcernedSweden - MPA
    A.2EudraCT number2004-000299-15
    A.3Full title of the trial
    A double-blind, dose-response, phase II, multicentre study of radium-223 (Alpharadin TM ) for the palliation of painful bone metastases in hormone refractory prostate cancer patients
    A.4.1Sponsor's protocol code numberBC1-03
    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 SponsorAlgeta AS
    B.1.3.4CountryNorway
    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 Information not present in EudraCT
    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 nameAlpharadin
    D.3.2Product code NA
    D.3.4Pharmaceutical form Solution for injection
    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 INNNA (The INN Expert group has confirmed not to assign an INN name for this well-established chemical name.)
    D.3.9.1CAS number 444811-40-9
    D.3.9.2Current sponsor codeRadium-223 Drug Substance
    D.3.10 Strength
    D.3.10.1Concentration unit kBq/ml kilobecquerel(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number500 and 1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 No
    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
    The target population is patients suffering from bone pain due to skeletal metastasis secondary to prostate cancer.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate whether there is a dose-response relationship for radium-223 in patients with painful bone metastases secondary to prostate carcinoma regarding the palliation of bone pain. The palliative efficacy will be established through assessments of bone pain and consumption of analgesia.
    E.2.2Secondary objectives of the trial
    The secondary objective is to find the most efficient dose with an acceptable safety profile. The safety will be assessed through measurements of adverse events, and acute haematological toxicity during the study period. Long-term chronic toxicity, and the overall survival at one and two year post-treatment will also be assessed.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Histologically/cytologically confirmed adenocarcinoma of the prostate
    2. Patient is hormone refractory with evidence of progressive disease:
    - Patient must be maintained on androgen ablation therapy with LHRH agonist, or is currently treated with polyestradiolphosphate to castrate level, or have undergone orchiectomy
    - Patient’s testosterone level is required to be equal to or below 50 ng/dl
    - Patients in which flutamide, nilutamide, megestrol acetate, polyestradiolphosphate, aminoglutethimide, and ketoconazole, has been recently added or withdrawn must demonstrate progression of disease and be at least 4 weeks beyond the start or discontinuation of such agents; for bicalutamide 6 weeks is required
    - Increase in PSA levels in two consecutive measurements with at least one week apart, demonstrating an increase over the reference (nadir) value, and with the final PSA > 5 ng/ml
    o A reference PSA (nadir) value must be measured at least 4 weeks after the start or discontinuation of flutamide, nilutamide, megestrol acetate, polyestradiolphosphate, aminoglutethimide, and ketoconazole, and at least 6 weeks after start or discontinuation of bicalutamide
    o If the third PSA value is lower than the second value, the patient could still be eligible, provided a fourth measurement obtained at least 1 week after the third PSA value, is greater than the second PSA value and > 5 ng/ml
    3. Multifocal (>1) skeletal metastases confirmed by bone scintigraphy within the last 6 weeks
    4. Bone pain with a score of at least 2 on BPI average pain, despite adequate use of analgesics, that correlates with areas of increased uptake (osteoblastic activity) on bone scintigraphy
    5. Performance status: ECOG 0-2 or Karnofsky ³ 60%
    6. Life expectancy: At least 3 months
    7. Age more than 40 years
    8. Laboratory requirements:
    a. Neutrophil count > 1,5 x 109/L
    b. Platelet count at least > 100 x109/L
    c. Hemoglobin > 95 g/L
    d. Bilirubin within normal institutional limits
    e. ASAT and ALAT < 2,5 times upper limit of normal (ULN)
    9. The patient is willing and able to comply with the protocol (including maintenance of patient diary and completion of pain assessment forms), and agrees to return to the hospital for follow-up visits and examination
    10. The patient has been fully informed about the study and has signed the informed consent form
    E.4Principal exclusion criteria
    1. Has received an investigational drug within 4 weeks before the administration of radium-223, or is scheduled to receiving one during the study period
    2. Has received chemo-, immunotherapy, or external radiotherapy within the last 4 weeks prior to entering the study, or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
    3. Has received prior hemibody external radiotherapy
    4. Has received systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the last year prior to inclusion
    5. Has started treatment with bisphosphonates less than 3 months prior to administration of study drug
    6. Patients experiencing hormone withdrawal syndrome, or are < 4 weeks post withdrawal of antiandrogen therapy (6 weeks for bicalutamide)
    7. Patients who have started steroids or changed to treatment with steroids within the last 4 weeks prior to administration of radium-223
    8. Has other clinically significant or symptomatic disease, which might interfere with the assessment of bone pain, e.g. spinal cord compression, compression or infiltration of a neural plexus, nerve root or peripheral nerves
    9. Other currently active (relapse within the last 3 year) malignancy (except non-melanoma skin cancer), or known brain or visceral metastases dominating the clinical picture of the patient
    10. Other serious illness or medical condition:
    - any uncontrolled infection
    - cardiac failure Classification III or IV (New York Heart Association)
    - Crohn disease or Ulcerative colitis
    - known bone fracture within 8 weeks
    11. Patients with imminent or established spinal cord compression based on clinical findings and/or MRI
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are the endpoints needed to classify a patient as a pain responder (“minimal response”, “moderate response”, “marked response” or “complete response”) or a non-responder (“no pain response” or “pain progression”) (see paragraph 9.1.3). These endpoints are:
    - Pain assessment; the patient’s self assessment of his “average pain over the last 24 hours” using a 100 mm Visual Analogue Scale where 0 is “no pain” and 100 is “pain as bad as you can imagine”
    - Analgesic consumption
    The classification of each patient into one, and only one, of the categories will be based on a combination of the change of bone pain (reduction or increased compared to baseline), and change in analgesic consumption during the study period compared to the patient’s prescribed analgesic consumption at baseline.
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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.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 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 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 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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months11
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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 Decision2004-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-11-03
    P. End of Trial
    P.End of Trial StatusOngoing
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