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    Summary
    EudraCT Number:2011-000240-16
    Sponsor's Protocol Code Number:20110106
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-04-07
    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 ConcernedSweden - MPA
    A.2EudraCT number2011-000240-16
    A.3Full title of the trial
    A MULTICENTER PHASE II STUDY EVALUATING EFFICACY AND SAFETY OF 177Lu-DOTA-TATE BASED ON KIDNEY-DOSIMETRY IN PATIENTS WITH DISSEMINATED NEUROENDOCRINE TUMORS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial evaluating the efficacy and safety of Lutetium-treatment for advanced neuroendocrine tumors
    A.3.2Name or abbreviated title of the trial where available
    ILUMINET
    A.4.1Sponsor's protocol code number20110106
    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 SponsorSkånes Onkologiska Klinik, Skåne University Hospital, Lund
    B.1.3.4CountrySweden
    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 supportSkånes Onkologiska Klinik, Skånes Universitetssjukhus
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportOnkologiska Kliniken, Sahlgrenska Universitetssjukhuset, Göteborg
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKliniska Forsknings Enheten
    B.5.2Functional name of contact pointKFE
    B.5.3 Address:
    B.5.3.1Street AddressGetingevägen
    B.5.3.2Town/ cityLund
    B.5.3.3Post code22185
    B.5.3.4CountrySweden
    B.5.4Telephone number+4646171000
    B.5.5Fax number+4646176023
    B.5.6E-mailanna.sundlov@skane.se
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/07/523
    D.3 Description of the IMP
    D.3.1Product name177Lu-DOTA-TATE
    D.3.2Product code Lu-177
    D.3.4Pharmaceutical form Radiopharmaceutical precursor, solution
    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.3.9.3Other descriptive nameLutetium octreotate
    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
    Metastatic neuroendocrine tumors
    E.1.1.1Medical condition in easily understood language
    Advanced neuroendocrine tumors
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10052399
    E.1.2Term 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
    Att undersöka effektivitet och toxicitet av en optimalt administrerad behandling med 177Lu-DOTA-TATE till en kumulativ BED till njurarna av 27 +/- 2 Gy.
    E.2.2Secondary objectives of the trial
    Att undersöka effektivitet och toxicitet av en optimalt administrerad behandling med 177Lu-DOTA-TATE till en kumulativ BED till njurarna av 40 +/- 2 Gy i en selekterad grupp patienter, utan potentiella riskfaktorer, och jämföra resultatet med det man erhållit efter 27 +/- 2 Gy.

    Att göra en intra-individuell jämförelse av tumörsvar, mätt i millimeter, efter 27 resp 40 +/- 2 Gy, i den grupp som erhållit den högre dosen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Steg 1
    ECOG 0-2
    Histologiskt verifierad neuroendokrin tumör med ett proliferationsindex på max 20% mätt med Ki67 och/eller max 20 mitoser/hpf. Om det histologiska materialet är gammalt bör prövaren överväga ny biopsi, särskilt om tumörens beteende har förändrats sedan initial senaste biopsin
    Metastaserad sjukdom där komplett resektion av metastaserna ej bedöms vara möjlig.
    Mätbar sjukdom enligt RECIST v1.1
    Progressiv sjukdom under de senaste 14 månaderna baserat på CT
    De största metastaserna har ett upptag av 111In-Octreotid motsvarande minst grad 3 enligt Krennings skala vid planar scintigrafi. Vid små (<2cm) eller centralt belägna tumörer, kan inklusion baseras på SPECT förutsatt att upptaget även här bedöms vara högre än leverupptaget. För att lutetium-behandling ska bli aktuell måste merparten av den totala tumörbördan visa ett högt upptag enligt ovan.
    Stabil SSA-dos de senaste 3 månaderna.. Förlängda uppehåll inför behandlingar är däremot tillåtna
    Förväntad överlevnad > 6 månader
    Neutrofila >1,5 x 109/L
    Trombocyter >100 x 109/L
    Bilirubin <1,5 x övre normalvärdet.
    GFR minst 50 ml/min mätt med antingen iohexol-clearance eller 51Cr EDTA
    Skriftligt bekräftat informerat samtycke

    Steg 2
    Uppfyller fortfarande alla inklusions- och inga exklusionskriterier från steg 1
    Bevarad GFR (<40 % försämring jfr med utgångsvärdet och GFR >50.0 ml/min)
    Behandlingarna under steg 1 har kunnat ges inom maximalt intervall av 12 veckor
    Ålder högst 70 år
    E.4Principal exclusion criteria
    Steg 1
    Performance Status ECOG 3 & 4.
    Proliferationsindex (Ki67) >20% eller > 20 mitoser/hpf
    Lokal behandling under de senaste 3 månaderna omfattande alla mätbara förändringar enligt RECIST.
    Cytostatika behandling under senaste 3 månaderna eller längre vid kvarstående toxicitet. Tidigare behandling med mTORi eller TKI är ej hinder för inklusion, förutsatt att ev. toxicitet är utläkt.
    Konkomitant medicinering med njurtoxiska läkemedel (t ex aminoglykosider)
    Ändringar av somatostatindoser under senaste 3 månaderna före första behandlingen
    Allvarlig hjärtinkompensation (NYHA IV)
    Tidigare strålbehandling omfattande >25% av aktiv benmärg
    Graviditet och amning
    Extensiv levermetastasering med tecken till sviktande leverfunktion
    Symtomatiska CNS metastaser som kräver corticosteroid terapi
    Pågående interferonbehandling. Definitiv utsättning 4 veckor före behandling eller längre om kvarstående toxicitet
    Annan metastaserande tumörsjukdom

    Steg 2
    Progressiv tumörsjukdom sedan start av studiebehandling
    Organtoxicitet grad 3-4 under steg 1
    Hematologisk toxicitet under föregående behandlingar (nadir på ANC<0.5x109 eller trombocyter <50.0)
    Långvarig diabetes ( > 8 års tid). Patienter med välreglerad diabetes med en anamnes <8 år och ett BT <130/80 och utan albuminuri kan inkluderas (förhöjt albumin/kreatinin index på morgonurin)
    Hypertoni, dvs >160/90 (För diabetiker >130/80). Antihypertensiv medicinering tillåten under förutsättning att det inte föreligger albuminuri (förhöjt albumin/kreatinin index på morgonurin)
    Tidigare leverembolisering
    Tidigare cytostatikabehandling
    E.5 End points
    E.5.1Primary end point(s)
    Tumörsvar 3 månader efter en kumulativ BED av 27 +/- 2 Gy (steg 1) mätt med RECIST v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 månader efter sista behandlingen inom steg 1, för varje patient.
    E.5.2Secondary end point(s)
    Tumörsvar 3 månader efter en kumulativ BED av 40 +/- 2 Gy (steg 2) mätt med RECIST v 1.1
    Tumörsvar efter steg 1 mätt i millimeter
    Tumörsvar efter steg 2 mätt i millimeter
    Progressionsfri överlevnad för patienter som enbart erhållit steg 1
    Progressionsfri överlevnad för patienter som erhållit steg 2
    Variationer av s-kromogranin-A under steg 1 resp steg 2.
    Toxicitet CTC v 3.0 under och efter steg 1
    Toxicitet CTC v 3.0 under och efter steg 2
    Värdering av livskvalitet mätt som ECOG performance status
    Total överlevnad i hela gruppen, och för patienter som erhåller 27 resp 40 +/- 2 Gy
    E.5.2.1Timepoint(s) of evaluation of this end point
    Bästa tumörsvar, toxicitet, progression och överlevnad utvärderas löpande var tredje månad under behandling- och uppföljningsfas.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 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
    Studien avslutas 3 år efter sista patientens sista behandling.
    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.1.1Number of subjects for this age range: 0
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state100
    F.4.2 For a multinational trial
    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)
    After end of trial patients will continue receiving standard care for their 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 Decision2011-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-12
    P. End of Trial
    P.End of Trial StatusOngoing
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    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
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