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    The EU Clinical Trials Register currently displays   40995   clinical trials with a EudraCT protocol, of which   6701   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2010-019862-10
    Sponsor's Protocol Code Number:A-93-52030-738
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-12-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-019862-10
    A.3Full title of the trial
    Randomised, phase III multicenter, open study of lanreotide in non metastatic castration-resistant prostate cancer patients presenting elevated Chromogranin A levels
    A.3.2Name or abbreviated title of the trial where available
    Poseidon
    A.4.1Sponsor's protocol code numberA-93-52030-738
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorIPSEN
    B.1.3.4CountryItaly
    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 Yes
    D.2.1.1.1Trade name IPSTYL
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLanreotide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 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 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
    Patients with prostate cancer presenting Neuro-Endocrine (NE) differentiation developing non metatstatic castrate resistant disease and eligible to second line hormone treatment with non steroidal anti androgens.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy in terms of Progression-free survival (PFS) of the administration of non steroidal anti androgens and LHRH-a (Arm A) versus lanreotide in addition to non steroidal anti androgens and LHRH-a (Arm B) as second line approach in non metastatic prostate cancer patients with castrate resistant disease and elevated CgA circulating levels. According to the updated guidelines of the PCWG2 Progression-free survival (PFS) will be considered a composite end point defined as the time from random assignment to disease progression in bone or soft-tissue, symptoms, or death.A rising PSA alone will not be considered an indicator of disease progression since radiographic or symptomatic progression better reflect changes in clinical status.Subjects stopping the study for any reason, including isolated PSA increase, will be censored at their last date of evaluation.Patients without tumor progression or death at the time of analysis will be censored at their last date of evaluation
    E.2.2Secondary objectives of the trial
    To compare safety between Arm A and Arm B. To compare PSA response and median times to PSA response between Arm A and Arm B. To compare PSA doubling median times between Arm A and Arm B. To compare median times to PSA progression and Overall Survival (OS defined as the time from randomisation to death due to any cause). To compare the reduction from baseline in CgA serum levels between Arm A and Arm B. To correlate the changes in serum CgA with PSA response.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age equal to or greater than 18. Histologically proven diagnosis of prostate cancer. Evidence of PSA progression despite castrate levels of testosterone (<50 ng/dL) following orchiectomy or during therapy with luteininzing hormone releasing hormone agonists (LHRH-a). Chromogranin A elevation above normal range (cut off levels will be > 20 U/L for ELISA assay and > 100 ng/ml for IRMA assay). ECOG Performance Status 0-1 Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 14 days prior to the start of the study treatment: Hb > 9.0 g/dl, absolute neutrophil count (ANC) > 1.500/mm3, platelet count >100.000/ml, total bilirubin < 1.5 times the upper limit of normal (ULN), AST and ALT < 2.5 x ULN (< 5 x ULN for patients with liver involvement of their cancer), serum creatinine < 1 x ULN Life expectancy of at least 6 months. Written informed consent
    E.4Principal exclusion criteria
    Patients with radiological signs of metastatic disease. Patients who according to the investigator opinion are candidate to be treated immediately with chemotherapy (e.g. docetaxel). Patients previously treated with total androgen ablation. Patients eligible to steroidal anti androgens. Diastolic blood pressure >100 mm/Hg despite anti-hypertensive drugs. Clinically significant cardiovascular disease (e.g. cerebrovascular accidents, myocardial infarction, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication). Renal impairment (creatinine levels above NL).Severe Parkinson disease. Known history of atrophic gastritis. Known history of cholelithiasis. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma effectively treated. Previous or concomitant treatment with a somatostatin analogue. Patients with known allergy to any of the components of the study medication.Concomitant assumption of drugs able to interfere with CgA synthesis. Treatment with any investigational drug within 30 days prior to enrolment.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the efficacy in terms of PFS of the administration of non steroidal anti androgens and LHRH-a (Arm A) versus lanreotide in addition to non steroidal anti androgens and LHRH-a (Arm B) as second line approach in prostate cancer patient with castrate resistant disease and elevated CgA circulating levels. As per PCWG2 updated guidelines PFS will be considered a composite end point defined as the time from random assignment to disease progression in bone or soft-tissue, symptoms, or death (if death occurs before 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 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 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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 Yes
    E.8.2.3.1Comparator description
    nessun trattamento sperimentale aggiuntivo
    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 concerned25
    E.8.5The trial involves multiple Member States No
    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 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
    Incidenza/gravita` degli eventi avversi tali da rappresentare un pericolo potenziale per la salute dei soggetti in studio.Arruolamento insufficiente.Disponibilita` di nuove informazioni che cambiano il rapporto rischio/beneficio atteso
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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.1.1.1In 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 state140
    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 Decision2010-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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