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    Summary
    EudraCT Number:2012-003666-41
    Sponsor's Protocol Code Number:IJBMNLUMEN
    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:2012-12-21
    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 number2012-003666-41
    A.3Full title of the trial
    The LuMEn study
    177Lu-octreotate treatment outcome prediction using Multimodality imaging in refractory neuroEndocrine tumours
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical-imaging study assessing the value of biological parameters obtained through multimodality molecular and functional imaging (differences in 68Ga-octreotate and 18FDG uptake, changes in diffusion weighted magnetic resonance imaging and 177Lu-octreotate dosimetry) for the prediction of treatment outcome in advanced refractory gastroenteropancreatic neuroendocrine tumors.
    A.3.2Name or abbreviated title of the trial where available
    LuMEn
    A.4.1Sponsor's protocol code numberIJBMNLUMEN
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01842165
    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 SponsorJules Bordet Institute
    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 supportJules Bordet Institute
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJules Bordet Institute
    B.5.2Functional name of contact pointIoannis Karfis
    B.5.3 Address:
    B.5.3.1Street Address121 boulevard de Waterloo
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1000
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3225413178
    B.5.5Fax number+3225413224
    B.5.6E-mailioannis.karfis@bordet.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 No
    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 name177Lu-DOTATATE
    D.3.4Pharmaceutical form Solution for 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 INNNo INN
    D.3.9.2Current sponsor code177Lu_DOTATATE_IJB
    D.3.9.3Other descriptive nameLUTETIUM(177LU)-DOTA-(TYR3)-OCTREOTATE
    D.3.9.4EV Substance CodeSUB177319
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number7.2 to 7.6
    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
    Patients with proved progressive (or refractory to standard systemic therapy available in Belgium at the time of inclusion) neuroendocrine tumors, not amenable to surgical resection with curative intent.
    E.1.1.1Medical condition in easily understood language
    Advanced neuroendocrine tumor patients who progresses or not responding to standard systemic therapy, and not possible surgery with curative intent.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10062476
    E.1.2Term Neuroendocrine tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    For each lesion: To assess the value of the following parameters (obtained through functional and molecular imaging) for predicting the lesion-by-lesion PRRT treatment outcome:
    - 18FDG uptake on 18FDG PET/CT,
    - 68Ga-octreotate uptake on 68Ga-octreotate PET/CT,
    - Apparent Diffusion Coefficient on Diffusion Weighted-MRI,
    [for these three parameters, absolute values at baseline will be assessed]
    - Tumor dosimetry on post-177Lu-octreotate SPECT/CT after the first cycle.
    E.2.2Secondary objectives of the trial
    Secondary objective:
    To generate a patient-based response model based on the previously defined parameters.

    Exploratory objectives:
    For each lesion: to assess the value of the parameters mentioned in section 3.1 for predicting the lesion-by-lesion PRRT treatment outcome:
    - absolute values of the three imaging parameters and their relative changes after each cycle;
    - serial tumor dosimetry on post-177Lu-octreotate SPECT/CT after each cycle
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria: Patient-based
    1. Age above or equal to 18 years.
    2. Histology-proven advanced GEP-NETs.
    3. Disease progression defined as follows (at least one of the following):
    - Radiological disease progression (according to RECIST 1.1) on an MRI or CT over the last 12 months
    Or
    - Disease progression on a somatostatin receptor-imaging, PET/CT or SPECT/CT over the last 12 months [apparition of new lesion(s) or increase in the transaxial plane diameter of more than 30% on the same imaging modality]
    Or
    - Both of the following criteria (a+b):
    a. clinical progression:
    - sustained (for more than 2 weeks) increase of NET-specific hormonal hypersecretion related symptom frequency by 50% or,
    - sustained (for more than 2 weeks) increase of severity by 1 grade (according to NCI-CTCAE version 4.03).
    b. biochemical progression: by increase of NET-specific tumor markers (plasma Chromogranin A, plasma NSE, urine 5-HIAA or other) in two successive measurements.
    4. Disease refractory to SSA’s and/or standard systemic therapy available in Belgium at the time of inclusion criteria.
    5. Long-acting SSAs should be discontinued at least 4 weeks before study treatment start date and, if needed, switched to short-acting analogues which should be stopped 48h before the treatment date.
    6. Adequate renal function with GFR ≥ 50 mL/min/1.73m2 (evaluated by 51Cr-EDTA test).
    7. Adequate bone marrow function with hemoglobin ≥ 9 g/dL; neutrophil ≥ 1.5·103/μL; platelet count ≥ 100·103/μL.
    8. Adequate liver function with total bilirubin ≤ 2 x ULN and transaminases ≤ 5 x ULN, serum albumin > 3 g/dL with normal prothrombin time (> 70%).
    9. ECOG Performance Status ≤ 1.
    10. Women of childbearing potential and men with partners of childbearing potential must agree to use a highly‐effective form of contraception for the duration of study participation and up to six months after the end of the treatment. A pregnancy test (serum) must be performed within 4 weeks prior to inclusion for every female patient of childbearing potential and it must be negative.
    11. Patient’s written informed consent obtained prior to any study procedure.
    12. All necessary baseline procedures should be performed within 4 weeks prior to first 177Lu-octreotate injection (D0).

    Inclusion Criteria: Lesion-based
    13. The patient must have at least one target lesion fulfilling all of the below criteria:
    • On the 68Ga-octreotate PET/CT: tumor uptake higher than the physiological liver uptake (grade III or IV of the Rotterdam visual score30) in a lesion with longest transaxial plane diameter ≥ 20mm (measured on the CT, part of the PET/CT);
    • At least one of these lesions morphologically measurable according to RECIST 1.1 and progressive on the MRI (or CT if MRI is not applicable);
    • Target lesion shall not have been previously irradiated.
    E.4Principal exclusion criteria
    1. Resectable tumor with curative intent.
    2. Any major surgery within the last 6 weeks prior to inclusion in the study
    3. Radiotherapy, chemotherapy, embolization, mammalian target of rapamycin (mTOR)-inhibitors, receptor tyrosine-kinase inhibitors, interferon, or other investigational therapy within the last 12 weeks prior to inclusion in the study.
    4. Diffuse bone marrow infiltration on the baseline 68Ga-octreotate PET/CT confirmed by MRI.
    5. Prior external beam radiotherapy on kidneys or on more than 25% of bone marrow.
    6. Patients with known uncontrolled brain metastases.
    7. Patients with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the investigator’s opinion, may interfere with completion of the study.
    8. Pregnant or lactating patients.
    9. Women of childbearing potential and men with partners of child-bearing potential refusing an adequate contraception.
    E.5 End points
    E.5.1Primary end point(s)
    The time to progression (TTP) for each target lesion assessed on MRI (or on CT scan if MRI is not applicable). TTP is defined as the time between treatment initiation and objective tumor progression with censoring of patients who die as a result of any cause. Progression is defined in the Treatment Modalities paragraph.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After morphological progression of the patient (according to RECIST 1.1)
    E.5.2Secondary end point(s)
    Secondary endpoints:
    • Best morphological response according to RECIST 1.1,
    • Progression Free Survival (PFS). PFS is defined as the time between treatment initiation and the first of the following events: disease progression (clinical or radiological) or death resulting from any cause. Progression is defined in the Treatment Modalities paragraph.
    • Biochemical response (evolution of NET-specific tumoral markers, as for inclusion).

    Exploratory endpoints:
    The time to progression (TTP) for each target lesion assessed on MRI (or on CT scan if MRI is not applicable). Progression is defined in the Treatment Modalities paragraph.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For the secondary endpoint:
    After morphological progression of the patient (according to RECIST 1.1)

    For the exploratory endpoints:
    After each cycle of treatment
    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 No
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    End of study will be declared when all the following criteria will have been met:
    - Two years after the date of the inclusion of the last patient
    - Safety reporting has been done for all patients
    - The trial is mature for the analysis of the endpoints as defined in the protocol, if the trial reaches its endpoints
    - The database has been fully cleaned and frozen for all analyses
    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: 26
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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)
    Best medical routine care
    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 Decision2013-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-09-16
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