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    Summary
    EudraCT Number:2009-013222-16
    Sponsor's Protocol Code Number:8-55-52060-004
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-10-01
    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 ConcernedLatvia - SAM
    A.2EudraCT number2009-013222-16
    A.3Full title of the trial
    Phase II, open, adaptive, dose escalating, multicentre titration study to assess the efficacy and safety of repeated subcutaneous administration of different doses of BIM 23A760 in patients with carcinoid syndrome
    A.4.1Sponsor's protocol code number8-55-52060-004
    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 Pharma
    B.1.3.4CountryFrance
    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 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 nameN/A
    D.3.2Product code BIM 23A760
    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.3.9.1CAS number 868562-36-1
    D.3.9.2Current sponsor codeBIM 23A760
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    carcinoid syndrome
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10007270
    E.1.2Term Carcinoid syndrome
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of repeated s.c. injections at different doses of BIM 23A760 on patient’s overall satisfaction in terms of symptom relief (diarrhoea and/or flushes) in patients with carcinoid syndrome after 24 weeks of treatment.
    E.2.2Secondary objectives of the trial
    •To assess the efficacy of repeated s.c. injections at different doses of BIM 23A760 on carcinoid symptoms (diarrhoea and/or flushes)
    • To assess the efficacy of BIM 23A760 on quality of life (QoL)
    • To assess the efficacy of BIM 23A760 on 5-HIAA and chromogranin A
    • To investigate the safety and tolerability of BIM 23A760 administered by repeated s.c. injections at different doses to patients with carcinoid syndrome
    • To investigate the PK of BIM 23A760 administered by repeated s.c. injections at different doses to patients with carcinoid syndrome.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The patient has provided written informed consent prior to any study related procedures.
    2. Male or female, between 18 and 75 years inclusive.
    3. Females of childbearing potential must provide a negative pregnancy test at the start of the study. Female patients who are at risk of becoming pregnant must agree to use an effective method of contraception such as double barrier contraception, an injectable or implanted hormonal contraceptive, combined oral contraceptive or an intra-uterine device (IUD). The patient must agree to use the contraception for two months after the last investigational medicinal product (IMP) administration. Nonchildbearing potential is defined as being postmenopausal for at least 1 year, or permanently sterilised at least 3 months before study entry.
    4. Male patients must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception (see above).
    5. The patient has a carcinoid syndrome defined as ≥3 stools/day and/or ≥3 flushes/week at study entry (Visit 1). This will be confirmed at Visit 2 by reviewing the information provided in the patient diary card during the screening period.
    6. The patient has a well-differentiated mid-gut carcinoid tumour or serotonin secreting tumour of unknown localisation with hepatic metastasis (documented biopsy).
    7. The patient has elevated 5-HIAA (above the upper limit of normal (ULN)).
    E.4Principal exclusion criteria
    1. The patient has undergone surgery related to a neuroendocrine tumour (NET) within 4 weeks prior to study entry or has surgery planned during the study.
    2. The patient has received short acting somatostatin analogues (SSAs) within 2 weeks before study entry or has received short acting SSAs for more than 3 months.
    3. The patient has received a radiolabelled SSA at any time before study entry.
    4. The patient has received long acting SSAs as follows:
    • More than three injections at any time before study entry
    • Between one and three injections, with the last injection
    within the period before study entry referenced below.

    Lanreotide Lanreotide Lanreotide
    Autogel 60mg Autogel 90mg Autogel 120mg
    or Octreotide or Octreotide or Octreotide
    LAR 10mg LAR 20mg LAR 30MG

    1 injection 6 weeks 8 weeks 10 weeks
    2 injections 8 weeks 10 weeks 12 weeks
    3 injections 10 weeks 12 weeks 14 weeks

    5. The patient has a pancreatic tumour or a bronchial tumour.
    6. The patient has previously received any specific anti-tumour treatment such as chemotherapy, (chemo)embolisation, radiotherapy or interferon in the last 6 months or is anticipated to receive any of these treatments during the study (based on Investigator’s judgement).
    7. The patient is lactating or at risk of lactating during the study.
    8. The patient has signs or symptoms of cardiac insufficiency.
    9. The patient has an ejection fraction <40% and/or clinically severe cardiac valvular regurgitation, centrally assessed during the screening period.
    10. The patient has uncontrolled arterial hypertension.
    11. The patient has had a previous cancer (except basocellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus). Patients with a history of cancer that was not basocellular carcinoma of the skin or in situ carcinoma of the cervix/uterus can be included if they have been treated with curative intent and have been free from disease for more than 5 years.
    12. The patient has received BIM 23A760 prior to the study.
    13. The patient has uncontrolled diabetes (glycosylated haemoglobin (HbA1c) > 8%).
    14. The patient has insulin treated diabetes and has been treated for less than 6 months prior to study entry.
    15. The patient has any clinically significant hepatic abnormalities and/or aspartate aminotransferase (AST) >3 x ULN and/or alanine aminotransaminase (ALT) >3 x ULN and/or alkaline phosphatase (ALP) >3 x ULN and/or conjugated bilirubin >1.5 x ULN during the screening period.
    16. The patient has abnormal findings during the screening period, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the patient’s safety.
    17. The patient has been treated with any other IMP prior to the first study visit without undergoing a washout period of seven times the elimination half-life of the IMP.
    18. The patient has a known hypersensitivity to any of the test materials or related compounds.
    19. The patient is likely to require treatment during the study with drugs that are not permitted by the study protocol.
    20. The patient has a history of, or known current, problems with alcohol or drug abuse.
    21. The patient has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an unco-operative attitude.
    22. The patient belongs to any hierarchical, patient or other group where they may have been unduly influenced to participate in the trial (e.g. patients committed to an institution by virtue of an order issued either by any judicial or administrative authorities).
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of patients with a positive overall satisfactory relief of symptoms on the Likert score after 24 weeks of 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    adaptive - The number of patient treated at a starting dose will depend on a data review commitee
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    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
    The study will be considered to have finished (“end of study”) when the
    last patient has completed the last visit of the study.
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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 Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 80
    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)
    After completion of the final visit (Visit 11), patients will be able to receive further treatment for their symptoms, either with BIM 23A760 in an extension study or with another product.
    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 Decision2009-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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