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    Summary
    EudraCT Number:2013-000726-66
    Sponsor's Protocol Code Number:GETNE1206
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-05-12
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-000726-66
    A.3Full title of the trial
    Randomized open label study to compare the efficacy and safety of everolimus followed by chemotherapy with STZ-5FU upon progression or the reverse sequence, chemotherapy with STZ-5FU followed by everolimus upon progression, in advanced progressive pNETs (SEQTOR study)
    Randomisierte Open-Label-Studie zum Vergleich der Wirksamkeit und Sicherheit von Everolimus gefolgt von Chemotherapie mit STZ-5FU oder der umgekehrten Reihenfolge, d. h. Chemotherapie mit STZ-5FU gefolgt von Everolimus auf die Progression fortgeschrittener progredienter pNETs (SEQTOR-Studie)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized not blinded clinical trial to compare two sequences of treatment: STZ-5FU followed by everolimus or everolimus followed by STZ-5FU upon progression in advanced progressive pancreatic neuroendocrine tumors (SEQTOR study)
    Randomisierte Open-Label-Studie zum Vergleich zweier Behandlungssequenzen: Everolimus gefolgt von Chemotherapie mit STZ-5FU oder der umgekehrten Reihenfolge zur Behandlung fortgeschrittener pankreatischer neuroendokriner Tumoren (pNET)
    A.3.2Name or abbreviated title of the trial where available
    SEQTOR
    A.4.1Sponsor's protocol code numberGETNE1206
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02246127
    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 SponsorGrupo Español de Tumores Neuroendocrinos (GETNE)
    B.1.3.4CountrySpain
    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 supportNovartis
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportEuropean Neuroendocrine Tumours Society (ENETS)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGrupo Español de Tumores Neuroendocrinos (GETNE)
    B.5.2Functional name of contact pointTrial Lead Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressC/ Mare de Deu del Coll 75 1-2
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08023
    B.5.3.4CountrySpain
    B.5.4Telephone number34932134478
    B.5.5Fax number34932134478
    B.5.6E-mailcvidal@needsandaims.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Afinitor
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAfinitor
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEVEROLIMUS
    D.3.9.1CAS number 159351-69-6
    D.3.9.3Other descriptive nameEVEROLIMUS
    D.3.9.4EV Substance CodeSUB02065MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.2.5The 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 nameStreptozocin
    D.3.4Pharmaceutical form Powder for solution for injection/infusion
    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 INNSTREPTOZOCIN
    D.3.9.1CAS number 18883-66-4
    D.3.9.4EV Substance CodeSUB10658MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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.2.5The 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 name5-FLUOROURACIL
    D.3.4Pharmaceutical form Solution for injection/infusion
    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 INN5-FLUOROURACIL
    D.3.9.3Other descriptive name5-FLUOROURACIL
    D.3.9.4EV Substance CodeSUB27520
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    advanced progressive pNETs
    E.1.1.1Medical condition in easily understood language
    advanced pancreatic neuroendocrine tumours
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    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 20.0
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the progression free survival rate at 12 months which is the proportion of patients who are alive without progression to Course 1 therapy at 12 months from the date of randomization in STZ based CT vs Everolimus arms.
    E.2.2Secondary objectives of the trial
    •To compare efficacy of the combination STZ-5FU followed by Everolimus upon progression vs. the reverse sequence in treatment of advanced pNET, in terms of rate of patients with 2nd PFS at 140 +/-8 weeks of treatment, assessed by RECIST criteria 1.0.
    •To describe efficacy of the two treatment sequences as continuous variable Hazard Ratio, in advanced pNETs at 12 months (main analysis) and 140+/8weeks.
    • To determine whether overall survival of patients with advanced pNETs could be modified by upfront administration of each other treatment upon progression.
    • To compare clinical activity of STZ-5FU and Everolimus given in 1st or 2nd place in advanced pNETS, in terms of time to 1st and 2nd progression, response rate, early biochemical response, Quality of Life, cost-effectiveness of each sequence, to investigate the criteria for measuring PFS that correlate better with overall survival.
    • To compare safety, tolerability, cost-effectiveness of the two treatment sequences.
    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) Detection of predictive markers
    Version 2.0 of date 30th of January 2014
    The objective of this sub-study is the detection of predictive markers of
    pNET and patients' outcome, on paraffin embedded tumour blocks from
    patients included in SEQTOR clinical trial."

    2) Evaluation of a blood-based transcriptional assay - the NETest - as a biomarker of neuroendocrine tumor response
    NETest - Detection of a circulating NET fingerprint
    Ver 1.0, 13th March 2015
    The objective of this sub-study is to use the NETest as a measure of treatment response in the SEQTOR study. Including the NETest will provide additional information that can be used to evaluate therapeutic efficacy.

    3) PanNETassigner molecular subtypes assay
    Ver 1.0, 7th August 2018
    The aim of this sub-study is to evaluate the predictive value of the PanNET assigner assay for patients undergoing treatment with chemotherapy and everolimus. This test uses molecular technologies, looking at changes in RNA seen in tumor samples, to divide pancreatic NET patients into different molecular subtypes. It will be evaluated whether these molecular subtype results in combination with clinical data from the SEQTOR study can be used for patient prognostication and classification as well as prediction of treatment response for pNET patients.
    E.3Principal inclusion criteria
    1. Adult patients ≥ 18 years old.
    2. Histologically proven diagnosis of unresectable or metastatic,
    advanced pancreatic NET.
    3. Documented confirmation of pancreatic NET G1 or G2 as per ENETS
    classification system:
    G1: <2 mitoses per 2 mm2 and/or Ki-67 index ≤ 2%
    G2: 2–20 mitoses per 2 mm2 and/or Ki-67 index >2% and ≤ 20%
    4. Patients from whom a paraffin-embedded primary tumour or
    metastasis block is available and to be sent by courier (Section 7.2.10).
    Patient should give his/her consent for its use in future investigations.
    5. Before study inclusion, patients must show progressive disease
    documented by radiology within 12 months prior to study inclusion. If
    patient received anti-tumour therapy during the past 12 months, he/she
    must have radiological documentation of progressive disease while on or
    after receiving that anti-tumour therapy. Treatment naive patients can be also
    included if, under investigator's judgment, the patient needs active
    treatment with either chemotherapy or everolimus.
    6. Before starting with the second treatment in sequence, patients must
    show documented disease progression by RECIST 1.0 (local assessment)
    while on anti-tumour therapy or in case of toxicity caused by the first
    treatment period.
    7. ECOG Performance status score 0 - 2.
    8. Life expectancy > 12 months.
    9. Presence of measurable disease as per RECIST criteria 1.0,
    documented by a Triphasic Computed Tomography (CT) scan or
    multiphase MRI radiological assessment.
    10. Previous treatment with somatostatin (SS) analogues is allowed.
    Only those patients with active functioning syndrome at entry can
    continue with SS analogues during the study.
    11. Adequate bone marrow function, documented by ANC > 1.5 x 109/L,
    platelets > 100 x 109/L, haemoglobin > 9 g/dL.
    12. Adequate liver function documented by: serum bilirubin ≤ 2.0
    mg/dL, INR ≤ 2, ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN in patients with
    liver metastasis).
    13. Adequate renal function documented by: serum creatinine < 1.5 x
    ULN.
    14. Fasting serum cholesterol < 300 mg/dL or < 7.75 mmol/L and
    fasting triglycerides < 2.5 x ULN. If one or both thresholds are exceeded,
    the patient may only be included after starting treatment with an
    adequate lipid-lowering agent.
    15. Women with child-bearing potential must have a negative serum
    pregnancy test within 14 days prior to enrollment and/or a urine
    pregnancy test 48 hours before the administration of the first study
    treatment.
    16. Written Informed Consent obtained according to local regulations.
    E.4Principal exclusion criteria
    1. Patients with poorly differentiated pancreatic neuroendocrine tumor;
    this is, pNET G3 as per ENETS classification system:
    G3: 21 or more mitoses per 2 mm2 and/or Ki-67 index >20%
    2. Previous treatment with chemotherapy and/or mTOR inhibitors
    (sirolimus, temsirolimus, everolimus, deforolimus) or tirosyne kinase
    inhibitors (sunitinib, sorafenib, axitinib, pazopanib, regerafenib).
    3. Immune therapy or radiation therapy within 4 weeks prior to the
    patient entering the study.
    4. Hepatic artery embolization within the last 6 months (1 month if there
    are other sites of measurable disease), or cryoablation/radiofrequency
    ablation of hepatic metastasis within 2 months of enrolment.
    5. Previous treatment with Peptide-Receptor Radionuclide Therapy
    (PRRT) within the last 6 months and/or without progression following
    PRRT.
    6. Uncontrolled diabetes mellitus defined as: fasting serum glucose > 1.5
    x ULN.
    7. Patients with any severe and/or uncontrolled medical conditions such
    as:
    a. unstable angina pectoris, symptomatic congestive heart failure,
    myocardial infarction ≤ 6 months prior to randomization, serious
    uncontrolled cardiac arrhythmia,
    b. active or uncontrolled severe infection,
    c. severe hepatic impairment (Child Pugh C) is not allowed; moderate
    hepatic impairment (Child Pugh B and A) requires a reduced dose of
    everolimus (5mg and 7.5 mg daily respectively). Positive HBV-DNA and
    or HBsAg patients at screening should receive prophylaxis treatment.
    d. severely impaired lung function (spirometry and DLCO 50% or less of
    normal and O2 saturation 88% or less at rest on room air),
    e. active, bleeding diathesis
    8. Treatment with potent inhibitors or inducers of CYP3A isoenzyme
    (rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole,
    voriconazole, ritonavir, telithromycin) within 5 days immediately before
    the start of treatment (a list of clinically significant drug interactions is
    shown in section 6. Concomitant Medication).
    9. Patients on chronic treatment with corticosteroids or any other
    immunosuppressive agent.
    10. Patients known to be HIV seropositive.
    11. Known intolerance or hypersensitivity to everolimus or its excipients
    or other rapamycin analogues. Patients with rare hereditary problems of
    galactose intolerance, Lapp lactase deficiency or glucose-galactose
    malabsorption should not take this medicinal product.
    12. Known intolerance or hypersensitivity to 5FU or STZ or its excipients. (notice that this criterion includes patients with known dihydropyrimidine dehydrogenase deficiency)
    13. Participation in any other clinical trial or concomitant treatment with
    any other investigational drug.
    14. No other prior or concurrent malignancy is allowed except for the
    following: adequately treated basal cell or squamous cell skin cancer, or
    other adequately treated in situ cancer, or any other cancer from which
    the patient has been disease free for ≥ 3 years.
    15. Pregnant, lactating women or fertile adults not using effective birth
    control methods. If barrier contraceptives are used, these must be
    continued to be used throughout the trial by both sexes and for up to 8
    weeks after the end of treatment.
    16. For administrative matters (insurance) patients ≥ 95 are not
    allowed during the trial.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients who are alive without progression to Course 1 therapy at 12 months from the date of randomization in STZ based CT vs Everolimus arms.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 12 months of treatment from the date of randomization
    E.5.2Secondary end point(s)
    1. Second progression free survival defined as PFS of Course 1 + interval between treatments + PFS of Course 2, where PFS1 represents progression free survival of Course 1 and PFS2 represents progression free survival of Course 2.
    It will be expressed as the rate of second progression free survival; this is the proportion of patients which are free of second progression at 140±8 weeks.
    2. Second progression free survival (PFS of Course 1 + interval between treatments + PFS of course 2) as a continuous time variable.
    3. Time to first progression of STZ-5FU and Everolimus 10 mg/day or the reverse sequence in advanced pNETs.
    4. Time to second progression of STZ-5FU and Everolimus 10 mg/day or the reverse sequence in advanced pNETs.
    5. Time from first progression to second progression of STZ-5FU and Everolimus 10 mg/day or the reverse sequence in advanced pNETs.
    6. Response rate of STZ-5FU and Everolimus 10 mg/day or the reverse sequence in advanced pNETs assessed every 12 weeks.
    7. Quality of life score at baseline, upon progression and 30 days after the last dose of study treatment (both sequences).
    8. CgA levels at baseline and at 4 weeks of treatment start.
    9. Correlation between the four criteria for second progression free survival (RECIST 1.0, RECIST 1.1, composite RECIST 1.0 and composite RECIST 1.1) and Kendall tau variables.
    10. Overall survival (OS) of patients on treatment with the combination STZ-5FU chemotherapy followed by Everolimus 10 mg/day upon progression or the reverse sequence, in the treatment of advanced pancreatic neuroendocrine tumours (pNET).
    11. Number of adverse events, dose reductions, and total dose administered on patients treated with STZ-5FU followed by everolimus 10 mg/day or the reverse sequence, in advanced pNETs.
    12. Cost per progression free survival gained: Incremental cost-effectiveness ratio (ICER) of the differential of costs incurred on by each treatment arm (A and B): ICER= (Arm A costs – Arm B costs)/(Arm A 2nd PFS – Arm B 2nd PFS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At LVLS.
    2. At LVLS.
    3. At First visit of second treatment.
    4. At LVLS.
    5. At LVLS.
    6. Every 12 weeks.
    7. At baseline, upon progression and 30 days after the last dose of study treatment.
    8. At baseline and at 4 weeks of treatment start.
    9. At every tumor assessment (every 12 weeks)
    10. At LVLS.
    11. At every cycle.
    12. At LVLS.
    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 Yes
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    The study will end when all patients are followed up to patient death, or 140+/-8 weeks + 30days safety FU.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 140
    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
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation European Neuroendocrine Tumours Society (ENETS)
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-07-12
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