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    Summary
    EudraCT Number:2012-003936-21
    Sponsor's Protocol Code Number:TD-212-2308
    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:2013-09-26
    Trial 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 number2012-003936-21
    A.3Full title of the trial
    A PROSPECTIVE MULTICENTRIC, PROOF OF CONCEPT STUDY TO EVALUATE THE VALUE OF 18-FDG-PET-SCAN ON TUMOUR RESPONSE IN PATIENTS WITH A PROGRESSIVE PANCREATIC ENDOCRINE TUMOUR RECEIVING A COMBINATION THERAPY OF LANREOTIDE AUTOGEL 120 MG EVERY 28 DAYS AND SUNITINIB 37.5 MG DAILY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to evaluate if changes in a type of scan, 18-FDG-PET-scan, can predict the evolution of the tumour when receiving a therapy with lanreotide autogel and sunitinib for a pancreatic endocrine tumour
    A.3.2Name or abbreviated title of the trial where available
    SULA-P Study
    A.4.1Sponsor's protocol code numberTD-212-2308
    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 SponsorHôpital de Jolimont
    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 supportIPSEN NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHôpital de Jolimont
    B.5.2Functional name of contact pointThierry Delaunoit
    B.5.3 Address:
    B.5.3.1Street AddressRue Ferrer 159
    B.5.3.2Town/ cityHaine-Saint-Paul
    B.5.3.3Post code7100
    B.5.3.4CountryBelgium
    B.5.6E-mailThierry.DELAUNOIT@entitejolimontoise.be
    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 Gluscan 600MBq/ml
    D.2.1.1.2Name of the Marketing Authorisation holderAdvanced Accelerator Applications 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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUORINE (18F) FLUDEOXYGLUCOSE
    D.3.9.1CAS number 105851-17-0
    D.3.9.4EV Substance CodeSUB07680MIG
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number300 to 6000
    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 Yes
    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
    Progressive well or moderately differentiated neuroendocrine tumour of the pancreas
    E.1.1.1Medical condition in easily understood language
    neuroendocrine tumour of the pancreas
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10067518
    E.1.2Term Pancreatic neuroendocrine tumor
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10068916
    E.1.2Term Pancreatic neuroendocrine tumor metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10068909
    E.1.2Term Pancreatic neuroendocrine tumour metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate a possible correlation between 18-FDG-PET-scan changes 4 weeks after treatment initiation with lanreotide plus sunitinib and time to tumour progression
    E.2.2Secondary objectives of the trial
    • To assess the safety of the combination therapy
    • To assess the efficacy of the combination therapy of sunitinib and lanreotide autogel 120 mg expressed as median time to tumour progression
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Has provided written informed consent prior to any study-related procedures.
    2) Has a documented progressive pancreatic neuroendocrine tumour by means of imaging and based upon the RECIST 1.1 criteria for which the treating physician has decided to treat with sunitinib and lanreotide
    3) Presenting a positive or negative 18-FDG PET SCAN at study entry
    4) Has a World Health Organisation (WHO) performance score lower than or equal to 2.
    5) Ki-67 of the tumour is documented and is below 20%.
    6) Well differentiated neuroendocrine tumour according to the WHO 2000 criteria (G1 - G2)
    E.4Principal exclusion criteria
    1) Has previously been treated with sunitinib
    2) Has been treated with somatostatin analogues (long and short acting) during the last 6 months before inclusion.
    3) Is likely to require any additional concomitant treatment with anti-proliferative effect to sunitinib and lanreotide Autogel 120mg for the pancreatic neuro-endocrine tumour.
    4) Has been treated with radionuclide at any time prior to study entry
    5) Has a history of drug hypersensitivity with a similar chemical structure to lanreotide Autogel 120mg and/or sunitinib.
    6) Is likely to require treatment during the study with drugs that are not permitted by the study protocol.
    7) Is at risk of pregnancy or lactation. Females of childbearing potential must provide a negative pregnancy test at the start of study and must be using oral, double barrier or injectable contraception. Non childbearing potential is defined as post-menopausal for at least 1 year, surgical sterilization or hysterectomy at least three months before the start of the study.
    8) Has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
    9) Has abnormal findings at baseline, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
    10) Has been previously been enrolled in this study.
    E.5 End points
    E.5.1Primary end point(s)
    Patients will be clustered in groups according to their 18 FDG status at entry

    For the patients presenting a pos PET scan at entry, they will be clustered in groups according to the change in metabolism. Changes in metabolism will be expressed as : percentage decrease in SUV max at 4 weeks compared to SUV max at baseline:

    Group 1 :0% to 30 % decrease in tumour metabolism
    Group 2 : > 30 % decrease in tumour metabolism.


    Value of early response of (baseline compared with scan 4 weeks post treatment initiation of for negative scan at entry) PET scan using FDG on long term effect will be determined by correlating images to TTP : This is the percentage of patients in Group 2 presenting progressive disease at months 3,6,9 & 12 versus percentage of patients in Group 1 presenting progressive disease at months 3,6,9 & 12

    Tumour assessments will be performed by means of CT-scans or magnetic resonance imaging (MRI) at study entry, every 12 weeks and to confirm progression. Patients will be followed up to a minimum of 12 months or until progression whatever comes first. Patients will be followed until the last patient included in the study will have progression or a 12 months follow up visit whatever comes first.

    Only the CT-scan or MRI taken at study entry and at progression (not the confirmation of progression) will be used to document time to tumour progression.

    Modified Recist 1.1 criteria will be used to determine tumour response
    E.5.1.1Timepoint(s) of evaluation of this end point
    at months 3,6,9 & 12
    E.5.2Secondary end point(s)
    Tumour assessments will be performed by means of CT-scans or magnetic resonance imaging (MRI) at study entry, every 12 weeks and to confirm progression. Patients will be followed up to a minimum of 12 months or until progression whatever comes first. Patients will be followed until the last patient included in the study will have progression or a 12 months follow up visit whatever comes first.

    Only the CT-scan or MRI taken at study entry and at progression (not the confirmation of progression) will be used to document time to tumour progression.

    Modified Recist 1.1 criteria will be used to determine tumour response
    E.5.2.1Timepoint(s) of evaluation of this end point
    every 12 weeks untill tumour progression
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    predictive value of PET-scan examination
    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 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 concerned10
    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 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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 52
    F.1.3Elderly (>=65 years) No
    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 state52
    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)
    none, standard treatment
    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 Decision2014-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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