Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43858   clinical trials with a EudraCT protocol, of which   7284   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-003856-30
    Sponsor's Protocol Code Number:CSMS995ABE12T
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-10-07
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-003856-30
    A.3Full title of the trial
    Sandostatin (Octreotide LAR) may lead to clinical improvement through receptor occupation optimisation.
    A prospective interventional trial of patients with neuro-endocrine tumors with carcinoid syndrome receiving octreotide LAR.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial for patients with neuro-endocrine tumors with carcinoid syndrome receiving octreotide LAR.
    A.3.2Name or abbreviated title of the trial where available
    SCIROCCO
    A.4.1Sponsor's protocol code numberCSMS995ABE12T
    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 SponsorCliniques Universitaires Saint Luc
    B.1.3.4CountryBelgium
    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 supportCliniques Universitaires Saint Luc
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportNovartis pharma SA/NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBGDO vzw
    B.5.2Functional name of contact pointMicheline Stempin
    B.5.3 Address:
    B.5.3.1Street AddressLeuvensesteenweg 643
    B.5.3.2Town/ cityZaventem
    B.5.3.3Post code1930
    B.5.3.4CountryBelgium
    B.5.4Telephone number32474074584
    B.5.6E-mailclinicaltrials@bgdo.org
    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 Sandostatine Long Acting Repeatable (LAR) 10, 20, 30 mg
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma NV
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameSANDOSTATIN LAR
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The primary objective is to observe the change from baseline in the incidence of diarrhea and flushing in correlation to the serum octreotide level, independently of the dose variations of octreotide LAR.
    E.1.1.1Medical condition in easily understood language
    To observe the change from baseline in the incidence of diarrhea and flushing in relation to the serum octreotide level (level in the blood) independently of the dose variations of octreotide LAR.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to observe the change from baseline in the incidence of diarrhea and flushing in correlation to the serum octreotide level, independently of the dose variations of octreotide LAR.
    E.2.2Secondary objectives of the trial
    - To describe the number of symptoms in correlation to the serum octreotide level, defined by a blood level test of octreotide.
    - To describe the rate of diarrhea and flushing via a patient diary
    - To describe the impact of increased dose of octreotide LAR on the symptoms: bowel movements and flushing (via patient diary)
    - To describe the effect of Octreotide LAR on Quality of Life, based on the change from baseline in the OLO-GINET21 scores
    - To describe the effect of Octreotide LAR on tumor control according to RECIST 1.1 criteria
    - To describe the safety of octreotide (CTCAE grades)
    - To describe the correlation between the dose/frequency of octreotide LAR given and the serum octreotide level
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Written informed consent
    GEP NET Ki 67 ≤ 10 %
    Histologically or cytologically confirmed GEP NET
    Appearance of carcinoid syndrome maximum 6 months before the inclusion
    Evaluable or measurable disease (RECIST 1.1)
    WHO ECOG performance status 0-2
    Positive somatostatin receptor scintigraphy
    >18 years
    Life expectancy of at least 12 weeks
    E.4Principal exclusion criteria
    Uncontrolled concurrent disease which prevents the adequate management and follow-up of the NET.
    Previous malignancy in the last past 3 years except malignancies estimated as completely cured.
    Current pregnancy or breast feeding
    Concomitant anti-tumoral treatment, except external beam radiotherapy
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is defined as follows:
    - Treatment success: Symptom control is achieved within 2 years of treatment with octreotide LAR. Symptom control is defined as at least a 50% decrease of the mean number of bowel movements per day and the total number of flushes over 7 days AND a maximum frequency of less than 4 bowel movements a day.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Study timelines:
    Enrolment start date (FPI): 12/2015
    Enrolment finish date (LPI): 12/2018
    Treatment period end date (LP off treatment): 12/2020
    Follow-up period end date (LP off study): 2 years
    Planned date for primary analysis: 12/2020
    Planned date for final analysis: 12/2021
    E.5.2Secondary end point(s)
    - Treatment failure: No symptom control is achieved within 2 years of treatment with octreotide LAR.

    The response rate will be calculated as the number of patients with treatment success divided by the total number of included patients that received at least one injection of octreotide LAR.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Planned date for final analysis: 12/2021
    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 No
    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 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 No
    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 concerned15
    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 No
    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
    LVLS
    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 months
    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 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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 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 state50
    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)
    Expected normal 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 Decision2015-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 13:37:59 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA