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    Summary
    EudraCT Number:2008-002338-31
    Sponsor's Protocol Code Number:47
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-07-31
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-002338-31
    A.3Full title of the trial
    Prospektive randomisierte Phase II Studie zur Behandlung von Patienten mit fortgeschrittenem hormonrefraktären Prostatakarzinom mittels LHRH-Analoga und Somatostatin-Analoga unter Berücksichtigung der neuroendokrinen Expression sowie des Androgenrezeptorstatus
    A.3.2Name or abbreviated title of the trial where available
    Soma-47-Studie
    A.4.1Sponsor's protocol code number47
    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 SponsorHannover Medical School
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Somatuline Autogel® 60 mg Injektionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLANREOTIDE
    D.3.9.1CAS number 108736352
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 hormone - independent non metastatic prostate cancer
    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 main objective is to initiate a secondary hormone ablation with somatostatin analogues for patients with hormone-refractory prostate cancer following radical prostatectomy without computer tomographic or skeletal scintigraphic confirmed manifest metastatic lesions.
    Primary criteria:

    • PSA Response
    Assessment of the PSA (Prostate Specific Antigen) -based response (PSA-R) of patients with homone-refractory prostate cancer without evidence of manifest metastatic lesions receiving intramuscular somatostatin-analogue treatment.


    • CgA Response
    Assessment of the CgA (Chromogranin A) -based response (CgA) of patients with hormone-refractory prostate cancer without evidence of manifest metastatic lesions receiving intramuscular somatostatin-analogue treatment.
    E.2.2Secondary objectives of the trial
    -Biological effects
    -chromogranin A (CgA) in serum
    -Insulin-like growth factor (IGF-1) in serum
    -Overall survival
    -Assessment of safety and feasibility of a somatostatin-analogue therapy in patients with prostate cancer.

    Experimental study aims

    - Correlation of therapeutic response of a reduction of PSA or CgA with expression of PSA, CgA, AR and NeuroD1 in primary tissue.

    The aim of this study is to demonstrate the feasibility and safety together with the optimisation of efficacy of the described therapy in patients with biochemical relapse following radical prostatectomy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    • Patients who have given written informed consent prior to the study
    • Patients with biochemical relapse after radical prostatectomy under hormone ablative therapy using an LHRH analogue, or after surgical castration, with no computer tomographic or skeletal scintigraphic evidence of manifest metastatic lesions.
    • Serum testosterone < 1.75 nmol/l
    • Karnofsky index > 70
    • Age >40 /< 90
    • No previous or concomitant chemotherapy ( Exception: hormone therapy)
    • No concomitant radiotherapy
    • Clinical chemistry: essentially normal values for liver, pancreas and kidney function (bilirubin < UNL mg/dl, creatinine < 1.5x UNL mg/ dl, amylase and lipase within normal range)
    • No chronic obstructive lung disease or other allergic predisposition from medical history
    E.4Principal exclusion criteria
    • Karnofsky index < 70
    • Patients unwilling to give written informed consent to study participation
    • Previous pancreatic illness e.g. pancreatitis
    • Alcohol abuse
    • Obstructive lung disease or known allergic predisposition
    • Presence of an uncured second malignant disease
    • Intake of drugs which hinder functioning of the immune system
    • Previous chemotherapy
    • Concomitant radiotherapy
    • Cerebral seizures
    • Severe physical or psychological concomitant diseases which could impair the compliance of the patient to study protocol procedures or the evaluation of drug safety, e.g. clinically relevant ascites, cardic insufficieny> NYHA III, clinically relevant ECG anomalies
    • Intake of other study medication within 30 days prior to randomisation.
    E.5 End points
    E.5.1Primary end point(s)
    • PSA Response
    Assessment of the PSA (Prostate Specific Antigen) -based response (PSA-R) of patients with homone-refractory prostate cancer without evidence of manifest metastatic lesions receiving intramuscular somatostatin-analogue treatment.


    • CgA Response
    Assessment of the CgA (Chromogranin A) -based response (CgA) of patients with hormone-refractory prostate cancer without evidence of manifest metastatic lesions receiving intramuscular somatostatin-analogue treatment.
    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) 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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    no treatment
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    please see protocol
    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 months24
    E.8.9.1In the Member State concerned days
    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 state1
    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)
    if there is a treatment effect, continuation of Somatostatin-Analogon
    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 Decision2008-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-06-30
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