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   43851   clinical trials with a EudraCT protocol, of which   7283   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:2013-004069-14
    Sponsor's Protocol Code Number:PRODIGE31
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-09
    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 number2013-004069-14
    A.3Full title of the trial
    A european, multicentre, phase II/III randomised double-blind, placebo controlled study evaluating lanreotide as maintenance therapy in patients with non-resectable duodeno-pancreatic neuroendocrine tumours after first-line treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial realized in several centers and in several European countries to evaluate a maintenance treatment by lanreotide in patients having neuroendocrine tumors, localized in duodenum or pancreas. Lanreotide will be compared with the placebo, and neither the patients nor the doctors will know the treatment taken by the patients
    A.3.2Name or abbreviated title of the trial where available
    REMINET
    A.4.1Sponsor's protocol code numberPRODIGE31
    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 SponsorFédération Francophone de Cancérologie Digestive (FFCD)
    B.1.3.4CountryFrance
    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 supportIPSEN
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationICTA PM
    B.5.2Functional name of contact pointPascale Brosset-Savigny
    B.5.3 Address:
    B.5.3.1Street Address11 rue du Bocage
    B.5.3.2Town/ cityFontaine Les Dijon
    B.5.3.3Post code21121
    B.5.3.4CountryFrance
    B.5.4Telephone number33380534035
    B.5.5Fax number33380571022
    B.5.6E-mailpascale.savigny@icta.fr
    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® LP 120 mg
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN PHARMA SA
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 in pre-filled syringe
    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
    D.3.9.1CAS number 108736-35-2
    D.3.9.2Current sponsor codeBN 52030, BIM-23014C
    D.3.9.3Other descriptive nameLanreotide acetate [127984-74-1]
    D.3.9.4EV Substance CodeSUB08402MIG
    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
    Non-resectable duodeno-pancreatic neuroendocrine tumours after first line treatment
    E.1.1.1Medical condition in easily understood language
    Neuroendocrine tumors, localized in duodenum or pancreas, and which cannot be surgicaly removed after a first treatment
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10067517
    E.1.2Term Pancreatic neuroendocrine tumour
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase II:
    To evaluate the rate of patients alive and progression free at 6 months, assessed by the investigator according to RECIST criteria, version 1.1.

    Phase III:
    To assess and compare the Progression Free Survival (PFS) of lanreotide versus placebo according to RECIST criteria (version 1.1, Appendix 3), assessed by the investigator.
    E.2.2Secondary objectives of the trial
    Phase II:
    •Rate of patients alive and progression free at 12 months, assessed by the investigator according to RECIST criteria (version 1.1)
    •Rate of patients alive and progression free at 6 months, according to central review
    •Safety
    •Response rate at 6 months according to RECIST criteria (version 1.1)
    •Time To Progression (TTP)
    •Quality of life assessed with the questionnaire QLQ-C30, including module NET 21, and the Spitzer visual analogue scale.

    Phase III:
    •Overall Survival (OS) at 3 and 5 years
    •PFS according to central review
    •Safety
    •Response rate at 6 months according to RECIST criteria (version 1.1)
    •Chemotherapy / biotherapy-free time interval
    •Quality of life assessed with the questionnaire QLQ-C30, including module NET 21, and the Spitzer visual analogue scale.
    •Medico-economical evaluation: cost-effectiveness analysis at 12 months and cost-utility analysis at 18 months (using EQ-5D questionnaire).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1/ Research on biomarkers:
    The objective of the biological translational research project associated with this clinical study is to evaluate the prognostic and predictive value of the parameters collected during the analysis of tumour tissues and blood samples

    2/ Medico-economical evaluation:
    - At 12 months:
    •To evaluate the cost-effectiveness ratio associated with treatment with lanreotide versus placebo. It will be expressed in terms of cost per progression-free life year gained (PFLYG)
    •To compare the average cost and average effectiveness associated with lanreotide versus placebo
    - At 18 months:
    •To evaluate the cost-effectiveness ratio, expressed in terms of cost per PFLYG
    •To evaluate the cost-utility ratio associated with treatment by lanreotide versus placebo. It will be expressed in terms of cost per progression-free life year gained adjusted for quality of life (QAPFLYG), using the EQ-5D questionnaire.
    •To compare the average cost and average utility associated with lanreotide versus placebo
    •To evaluate the share of the different items of expenditure in the total cost of patients’ care management at 18 months.
    E.3Principal inclusion criteria
    •Metastatic (synchronous or metachronous) or locally advanced, non-resectable, well-differentiated duodeno-pancreatic neuroendocrine tumour, of grade 1 or 2 (WHO 2010 classification; Ki-67 ≤ 20%)
    •First-line treatment started due to (a, b OR c):
    a. Presence of symptomatic disease and/or hepatic invasion ≥ 50%
    and/or bone metastasis
    b. Documented tumour progression before first line treatment
    c. Disease progression under Somatostatin analogues (analogues
    stopped prior to starting the 1st line treatment)
    •Histologically confirmed (either on primary tumour or metastases)
    •Pathological diagnosis validated by the NET consulting pathologist
    •Documented stable disease or objective response after first-line treatment, within 4 weeks (28 days) prior to randomisation
    •The first-line treatment will consist of either a chemotherapy or targeted therapy (everolimus or sunitinib) as referred to TNCD or ENETS guidelines. Treatment must have been administered for 3 to 6 months for chemotherapy and for 6 months for targeted therapy
    •Non-functional tumour or gastrinoma controlled by PPIs
    •Age > or = 18 years
    •WHO 0, 1 or 2
    •Highly effective contraception for male or female patients of
    childbearing age, defined as: oral contraceptives, intra-uterine devices
    or surgical sterilisation (vasectomy, tubal ligation). Female patients should use this contraception throughout the treatment period and for 6 months after the last treatment administration. Male patients should use contraception throughout the treatment period and for 3 months after the last treatment administration.
    •Signed informed consent prior to initiation of any study-specific procedures or treatment.
    E.4Principal exclusion criteria
    •History of haematological malignancy or other cancer, except those treated for more than 5 years and considered as cured, carcinoma in situ of the cervix and treated skin cancer (excluding melanoma)
    •Poorly differentiated neuroendocrine carcinoma or NET grade 3 ENETS (Ki-67 > 20%)
    •If primary resected, bone metastasis exclusively
    •Total bilirubin ≥ 60 µmol/L
    •Uncontrolled diabetes
    •Contraindication to product used in the study or its components
    •Tumour arising in the context of a genetic disease
    •Pregnancy or lactation
    •Patients unable to undergo medical follow-up due to geographical, social, psychological or legal reasons
    •Concomitant participation in another clinical trial investigating a treatment during the treatment phase and within 30 days prior to the start of the study treatment.
    •Employment of the subject or a close relative (i.e. spouse/partner,
    child, parent or sibling) by the CRO, the study site
    •Patients deprived of their liberty by a judicial or administrative
    decision, patients admitted to a hospital, social institution or who are
    under a measure of legal protection, patients hospitalized without
    consent or who are in an emergency situation.
    E.5 End points
    E.5.1Primary end point(s)
    Phase II:
    The rate of patients alive and progression free at 6 months, evaluated according to the results of imaging assessment done 6 months after the randomisation. This evaluation will be done by the investigator according to RECIST criteria (version 1.1).

    Phase III:
    The progression free survival, considering the first radiological progression of the patient (investigator’s opinion) or death (any reason). The time will be calculated between the randomisation date and the date the first event occurred. Patients who are alive and progression free will be censored at the time of the last news or cut-off date (the date the first of these occurs will be considered).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase II:
    At 6 months

    Phase III:
    Approximately 10 years
    E.5.2Secondary end point(s)
    Phase II:
    •Rate of patients alive and progression free at 12 months (according to RECIST criteria version 1.1), assessed by the investigator
    •Rate of patients alive and progression free at 6 months, according to central review
    •Safety: the toxicities will be described using the NCI-CTC AE version 4.0
    •Response rate according to RECIST criteria at 6 months (version 1.1), according to the investigator. Response rate will be defined as complete or partial response to the treatment
    •Time to progression (median). This endpoint will be calculated from the randomisation date to the date of the first progression (clinical and radiological) according to the investigator
    •Quality of life (QLQ-C30 including module NET 21, the Spitzer visual analogue scale) will be described at each time-point.

    Phase III:
    The secondary endpoints of phase III will consist of the comparison between the placebo and the lanreotide, on:
    •Overall survival (OS) at 3 and 5 years. This endpoint will be estimated considering all deaths and the time will be calculated from the randomisation date to the date of death. Patients alive will be censored at the date of the last news or at the cut-off date
    •PFS according to central review, evaluated considering the first radiological progression of the patient (central review) or death (any reason). The time will be calculated from the randomisation date to the date the first event occurred. Patients alive and progression free will be censored at the date of the last news or at the cut-off date (the date the first of these occurs will be considered).
    •Safety: the toxicities will be described using the NCI-CTC AE version 4.0
    •Response rate at 6 months according to RECIST criteria (version 1.1). Response rate will be defined as complete or partial response to the treatment
    •Chemotherapy/targeted therapy-free time interval: the time will be calculated from the last chemotherapy/ targeted therapy (first-line treatment) administration, to the date of restart of first-line treatment or to the start of a new line (second-line treatment).
    •Quality of life (QLQ-C30 including module NET 21, the Spitzer visual analogue scale) will be described at each time-point
    •Average cost at 12 and 18 months
    •Effectiveness average at 12 and 18 months and utility index score average at 18 months using EQ-5D questionnaire.
    •Efficiency:
    - At 12 months; cost per progression free life year gained (PFLYG)
    - At 18 months: cost per PFLYG and cost per PFLYG adjusted for quality of life (QAPFLYG).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase II:
    At 6 months, 12 months and first progression (clinical and radiological) according to the investigator

    Phase III:
    At 6 months, 12 months, 18 months, 3 years, 5 years, and first radiological progression of the patient (central review) or death (whatever the reason).
    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) 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 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 No
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 years12
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years12
    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: 111
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 111
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 222
    F.4.2.2In the whole clinical trial 222
    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)
    According to the investigator's choice
    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 Decision2014-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-25
    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-Sat Apr 20 15:53:19 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA