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    Summary
    EudraCT Number:2010-019066-92
    Sponsor's Protocol Code Number:2-55-52030-730/TR321
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-06-16
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2010-019066-92
    A.3Full title of the trial
    A double-blind, randomized placebo-controlled clinical trial investigating the efficacy and safety of Somatuline Depot (lanreotide) Injection in the treatment of carcinoid syndrome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a research study to see whether Lanreotide Autogel will help control the diarrhea and/or flushing caused by carcinoid syndrome.
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code number2-55-52030-730/TR321
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00774930
    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 SponsorIpsen Pharma SAS
    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 supportIpsen Pharma SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIpsen Pharma SAS
    B.5.2Functional name of contact pointVP R&D Chief Scientific Officer
    B.5.3 Address:
    B.5.3.1Street Address65 quai Georges Gorse
    B.5.3.2Town/ cityBoulogne Billancourt CEDEX
    B.5.3.3Post code92650
    B.5.3.4CountryFrance
    B.5.4Telephone number33 1 58 33 50 00
    B.5.5Fax number33 1 58 33 50 01
    B.5.6E-mailct-application@ipsen.com
    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 120 MG
    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 nameLanreotide Autogel 120mg
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 acetate
    D.3.9.1CAS number 127984-74-1
    D.3.9.2Current sponsor codeBN 52030; BIM-23014C
    D.3.9.3Other descriptive nameLanreotide acetate
    D.3.9.4EV Substance CodeSUB14326MIG
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 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 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 placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Carcinoid syndrome
    E.1.1.1Medical condition in easily understood language
    A condition called carcinoid syndrome. which causes flushes and diarrhoea
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10007270
    E.1.2Term Carcinoid syndrome
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of Somatuline Depot / Lanreotide Autogel injections administered every 4 weeks (± 3 days) for the control of symptoms associated with carcinoid syndrome (diarrhea and/or flushing) as compared to placebo, measured by the usage of subcutaneous octreotide as rescue medication to control symptoms.
    E.2.2Secondary objectives of the trial
    1. To characterize the effect of Somatuline Depot / Lanreotide Autogel versus placebo on biochemical markers of tumor activity.
    2. To characterize the pharmacokinetic (PK) profile (Cmin) of Somatuline Depot / Lanreotide Autogel in patients with carcinoid syndrome.
    3. To evaluate the safety of Somatuline Depot / Lanreotide Autogel injections administered every 4 weeks (± 3 days).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female at least 18 years of age at the time of first dosing
    2. Patients must give signed informed consent before any study-related activities are conducted.
    3. Patients in the United States must have given written authorization for the release of protected health information in compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations; patients in other countries must provide appropriate authorization as needed by regulatory authorities in each country
    4. Patients must be willing to receive subcutaneous octreotide injections as rescue medication, as needed to control their symptoms, if any.
    5. If female, the patient must not be pregnant (confirmed by negative pregnancy test) and must have the following documented via verbally given history:
    - At least 1 year postmenopausal (natural cessation of menses), or
    - Surgically sterile (if by tubal ligation, surgery must have been performed more than 3 months prior to study entry at Screening Visit), or
    - If the patient is of childbearing potential and sexually active, she must be using an acceptable form of contraception (oral, injected, transdermal or implanted contraceptives, diaphragm or barrier method with spermicidal and/or intrauterine device); local methods such as condoms or sponges/vaginal tablets are not acceptable forms of contraception.
    6. Patients with a histopathologically confirmed diagnosis of carcinoid tumor or, a carcinoid tumor of unknown location with liver metastases (documented biopsy), and a history of carcinoid syndrome (flushing and/or diarrhea) that are either
    naïve to treatment with an SSTa or responsive (according to the opinion of the Principal Investigator) to conventional doses of LAR (≤ 30 mg every 4 weeks) or to daily doses of ≤ 600 μg of subcutaneous octreotide.
    7. Confirmation of positive somatostatin receptor status by SRS (up to 6 months prior to study entry at Screening Visit)
    8. Absence of tumor progression documented by two sequential CAT scans or two sequential MRIs (≥ 3 months apart); the last scan/MRI must have been performed within 6 months of study entry (Screening Visit).
    9. Patients previously treated with LAR must have received their last dose of LAR at least 4 weeks prior to first dose of study drug (no later than at the Screening Visit).
    10. Be able to communicate and cooperate with the Principal Investigator and the staff and willing to comply with the study instructions
    E.4Principal exclusion criteria
    1. Patient has a history of known allergy or hypersensitivity to:
    - Investigational drug or any components of its formulation
    - Octreotide
    2. History of carcinoid syndrome refractory to treatment with conventional doses of SSTa
    3. Treatment with any other investigational drug within 30 days prior to study entry (Screening Visit) and/or at any time during the patient’s participation in the study
    4. Treatment with interferon, chemotherapy and/or radiotherapy (a radiolabelled SSTa) and/or tumor debulking < 3 months prior to study entry (Screening Visit)
    5. History of hepatic arterial embolization, hepatic arterial chemoembolization and/or selective internal radiation therapy (eg. SIR-Spheres) < 6 months prior to study entry (Screening Visit)
    6. Short bowel syndrome
    7. Uncontrolled diabetes and/or hypertension
    8. Severe renal impairment (glomerular filtration rate < 30 mL/min/1.73m2) and/or severe liver impairment as evidenced by serum total bilirubin >1.5 mg/dL associated with bile duct blockage or with alkaline phosphatase (AP), aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT or SGPT) >5.0 ULN.
    9. Diagnosis of cardiac disease New York Heart Association functional classification > Class I. (Patient has limitation of physical activity. Ordinary physical activity causes undue fatigue, palpitation, or dyspnea)
    10. Life expectancy less than one year
    11. Any malignancies except:
    - Carcinoid tumor
    - Basocellular carcinoma of the skin
    - In situ carcinoma of the cervix
    - ≥ 5 years disease free after curative cancer treatment
    12. Any serious medical condition that could jeopardize the safety of the patient and/or the efficacy assessments of the study.
    13. Patient is being treated with a Proton Pump Inhibitor (PPI) and has been at a stable dose (no change in dose or frequency of administration) for less than 4 weeks at study entry (Screening Visit).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the usage of subcutaneous octreotide required to control symptoms associated with carcinoid syndrome, measured as the percentage of days that subcutaneous octreotide is used as rescue medication during the 16-week double-blind phase of the study, based on patient IVRS/IWRS diary records.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At protocol defined timepoints.
    E.5.2Secondary end point(s)
    • Frequency of diarrhea events (per day) during the 16-week double-blind phase of the study based on patient IVRS/IWRS diary records
    • Frequency of flushing events (per day) during the 16-week double-blind phase of the study based on patient IVRS/IWRS diary records
    • Usage of other rescue medications for diarrhea and/or flushing events (e.g., loperamide 2 mg tabs and/or tincture of opium), measured as the percentage of days that the medications were used as rescue medication during the 16-week double-blind phase of the study based on patient IVRS/IWRS diary records.
    • Proportion of patients who roll over into the open-label phase before completing the double-blind phase of the study
    • Changes from baseline in Quality of Life (QoL) during the 16-week double-blind phase of the study; assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 and based on the global health status subscore
    • Absolute changes from baseline in biochemical marker - plasma Chromogranin A (CgA) and urinary 5-hydroxyinodoleacetic (5-HIAA) during the 16-week double-blind phase of the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    At protocol defined timepoints.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    48-weeks (16-weeks, double-blind, placebo-controlled followed by initial 32-week open-label phase)
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Brazil
    Croatia
    Czech Republic
    India
    Latvia
    Poland
    Russian Federation
    Serbia
    South Africa
    Turkey
    Ukraine
    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
    N/A; definition EoT = 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 years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days2
    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.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 100
    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)
    Standard treatment of that condition
    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 Decision2010-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-15
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