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    The EU Clinical Trials Register currently displays   36399   clinical trials with a EudraCT protocol, of which   5997   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2007-006195-11
    Sponsor's Protocol Code Number:BC1-06
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-02-09
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2007-006195-11
    A.3Full title of the trial
    A double-blind, randomised, multiple dose, Phase III, multicentre study of Alpharadin in the treatment of patients with symptomatic hormone refractory prostate cancer with skeletal metastases.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Alpharadin in men with bone metastases from prostate cancer
    A.3.2Name or abbreviated title of the trial where available
    Not Applicable
    A.4.1Sponsor's protocol code numberBC1-06
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00699751
    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 SponsorAlgeta ASA
    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 supportAlgeta ASA
    B.4.2CountryNorthern Mariana Islands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlgeta ASA
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressP.O. Box 54 Kjelsås
    B.5.3.2Town/ cityOslo
    B.5.3.3Post codeNO-0411
    B.5.4Telephone number+472300 79 90
    B.5.5Fax number+472300 79 91
    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 nameAlpharadin
    D.3.2Product code Radium-223
    D.3.4Pharmaceutical form Solution for injection
    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 INNRadium-223 chloride
    D.3.9.1CAS number 444811-40-9
    D.3.9.2Current sponsor codeRadium-223
    D.3.9.3Other descriptive nameAlpharadin
    D.3.10 Strength
    D.3.10.1Concentration unit kBq/ml kilobecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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) 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 Yes
    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 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
    D.8.3Pharmaceutical form of the placeboSolution for injection
    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 with skeletal metastases
    E.1.1.1Medical condition in easily understood language
    Prostate cancer which has spread to bone
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10027452
    E.1.2Term Metastases to bone
    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
    To compare, in patients with symptomatic HRPC and skeletal metastases, the efficacy of best standard of care plus Alpharadin versus best standard of care plus placebo, with the primary efficacy endpoint being overall survival (OS).
    E.2.2Secondary objectives of the trial
    - Time to total-ALP progression
    - Total ALP response
    - Time to occurrence of first skeletal related event
    - Total ALP normalisation
    - Time to PSA progression
    -Time to occurrence of first use of external beam radiotherapy to relieve skeletal symptoms
    -Time to occurrence of first use of radio-isotopes to relieve skeletal symptoms
    - Time to occurrence of first new symptomatic pathological bone fractures (vertebral and non-vertebral)
    - Time to occurrence of first tumour related orthopaedic surgical intervention
    - Time to occurrence of first spinal cord compression
    - Time to occurrence of first start of any other anti-cancer treatment
    - Time to occurrence of first deterioration of ECOG PS by at least two points from baseline [includes death (score
    of 5), by definition]
    - Changes in PSA
    - Changes in total-ALP
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Substudy for Clinical Evaluation of QTc Interval Prolongation in a Subgroup of the Patient Population
    Date: 25 January 2010
    Objective: The aim of the BC1-06 ECG substudy is to obtain more information of any clinically relevant effect of Alpharadin on QTc prolongation and proarrhythmic potential.
    E.3Principal inclusion criteria
    1. Histologically or cytologically confirmed adenocarcinoma of the prostate
    2. Known hormone refractory disease defined as:
    • Castrate serum testosterone level: ≤ 50 ng/dL (1.7 nmol/L)
    • Bilateral orchiectomy or maintenance on androgen ablation therapy with LHRH agonist or polyestradiol phosphate throughout the study
    • Serum PSA progression defined as two consecutive increases in PSA over a previous reference value, each measurement at least 1 week apart)
    3. Serum PSA value ≥ 5 ng/mL (μg/L)
    4. Multiple skeletal metastases (≥ 2 hot spots) on bone scintigraphy within previous 12 weeks
    5. No intention to use cytotoxic chemotherapy within the next 6 months
    6. Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with EBRT for bone pain within previous 12 weeks
    7. Age ≥ 18 years
    8. ECOG Performance status (PS): 0-2
    9. Life expectancy ≥ 6 months
    10. Laboratory requirements:
    a. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
    b. Platelet count ≥ 100 x10^9/L
    c. Hemoglobin ≥ 10.0 g/dL (100 g/L; 6.2 mmol/L)
    d. Total bilirubin level ≤ 1.5 institutional upper limit of normal (ULN)
    e. ASAT and ALAT ≤ 2.5 ULN
    f. Creatinine ≤ 1.5 ULN
    g. Albumin > 25 g/L
    11. Willing and able to comply with the protocol, including follow-up visits and examinations
    12. Must be fully informed about the study and signed the informed consent form
    E.4Principal exclusion criteria
    1. Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period
    2. Eligible for first course of docetaxel, i.e. patients who are fit enough, willing and where docetaxel is available
    3. Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks ago (however ongoing neuropathy is permitted)
    4. Prior hemibody external radiotherapy
    5. Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks
    6. Prior treatment with radium-223
    7. Blood transfusion or erythropoetin stimulating agents within previous 4 weeks
    8. Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
    9. History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks
    10. Malignant lymphadenopathy exceeding 3 cm in short-axis diameter
    11. Imminent or established spinal cord compression based on clinical findings and/or MRI
    12. Any other serious illness or medical condition such as, but not limited to:
    • any uncontrolled infection
    • cardiac failure NYHA III or IV
    • Crohns' disease or Ulcerative colitis
    • Bone marrow dysplasia
    13. Unmanageable faecal incontinence
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival: time from date of randomisation to the date of death
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will be evaluated every 2 months until 1 year from first
    administration, and thereafter every 4 months until 3 years from first
    E.5.2Secondary end point(s)
    - Time to total-ALP progression
    - Total ALP response
    - Time to occurrence of first skeletal related event
    - Total ALP normalisation
    - Time to PSA progression
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Time to total-ALP progression
    i. in patients with no total-ALP decline from baseline (at least 12 weeks
    from baseline)
    ii. in patients with an initial total-ALP decline from baseline (confirmed
    by a second value obtained three or more weeks later).
    • Total-ALP response (approximately 4 or more weeks later).
    • Time to occurrence of first skeletal related event (throughout the
    • Total-ALP normalisation (return of total-ALP value to within normal
    range at 12 weeks in 2 consecutive measurements, at least 2 weeks
    • Time to PSA progression
    i. in patients with no PSA decline from baseline (at least 12 weeks from
    ii. in patients with an initial PSA decline from baseline (confirmed by a
    second value obtained three or more weeks later).
    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 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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.2.4Number of treatment arms in the trial2
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA110
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    Hong Kong
    United Kingdom
    United States
    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
    Provided in protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months8
    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.1.1Number of subjects for this age range: 0
    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.1.2.1Number of subjects for this age range: 225
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 675
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 780
    F.4.2.2In the whole clinical trial 900
    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)
    Normal standard of care.
    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 Decision2008-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-13
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