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    Summary
    EudraCT Number:2019-002450-23
    Sponsor's Protocol Code Number:190282
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-08-20
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2019-002450-23
    A.3Full title of the trial
    Dosimetry based PRRT versus standard dose PRRT with Lu-177-DOTATOC in NEN patients- a randomized study; a step towards tailored PRRT.
    Dosimetribaseret PRRT versus standard PRRT med Lu-177-DOTATOC til NEN patienter; et skridt mod skræddersyet PRRT behandling.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dosimetry based PRRT versus standard dose PRRT with Lu-177-DOTATOC in NEN patients- a randomized study; a step towards tailored PRRT.
    Dosimetribaseret PRRT versus standard PRRT med Lu-177-DOTATOC til NEN patienter; et skridt mod skræddersyet PRRT behandling.
    A.4.1Sponsor's protocol code number190282
    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 SponsorAnne Kirstine Arveschoug
    B.1.3.4CountryDenmark
    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 supportRegion Midt
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAnne Kirstine Arveschoug
    B.5.2Functional name of contact pointAnne Kirstine Arveschoug
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul-Jensens Boulevard 165, J220
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.4Telephone number4522404917
    B.5.5Fax number4578456220
    B.5.6E-mailannearve@rm.dk
    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/03/14/1269
    D.3 Description of the IMP
    D.3.1Product nameLu-177-DOTATOC
    D.3.4Pharmaceutical form 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 INNLu-177
    D.3.9.1CAS number 14265-75-9
    D.3.9.2Current sponsor codeLu-177
    D.3.9.3Other descriptive nameLUTETIUM LU-177
    D.3.9.4EV Substance CodeSUB38329
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number3 to 25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEDOTREOTIDE
    D.3.9.1CAS number 204318-14-9
    D.3.9.3Other descriptive nameDOTATOC
    D.3.9.4EV Substance CodeSUB179386
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number115 to 575
    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 neuroendocrine neoplasms origin from the gastrointestinal tract, pancreas, adrenal glands (pheochromocytomas.), lungs, or from unknown primary site
    Neuroendokrine neoplasmer
    E.1.1.1Medical condition in easily understood language
    Patients with neuroendocrine neoplasms origin from the gastrointestinal tract, pancreas, adrenal glands (pheochromocytomas.), lungs, or from unknown primary site
    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
    Primary:
    • Difference in progression free survival between NEN patients treated with dosimetry based versus standard PRRT. Defined as time from randomization to documented disease progression or death by any cause.
    E.2.2Secondary objectives of the trial
    Our secondary endpoints are:
    • Difference in tumor dose between dosimetry based and standard PRRT treatment groups
    • Difference in kidney toxicity between dosimetry based and standard PRRT treatment groups, measured by creatine, eGFR, cystatin-c, Tc-DTPA clearance, and kidney fibrosis markers PRO-6, C3M and LAMC1.
    • Difference in bone marrow function between dosimetry based and standard PRRT treatment groups, measured by hemoglobin, white blood cells, platelets.
    • Difference in subjective side effects between dosimetry based and standard PRRT treatment groups, evaluated by questionnaire.
    • Difference in quality of life between dosimetry based and standard PRRT treatment groups, evaluated by questionnaire EORTC QLQ-30 and QLQ-GI.NET21.
    • Difference in overall survival between dosimetry based and standard PRRT treatment groups.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients > 18 years of age
    2. NEN confirmed by histology
    3. Clinical, PET/CT or CT proven progression despite standard treatment with somatostatin analogues, targeted therapy (Everolimus, sunitinib), chemotherapy (STZ/5-FU, temozolomide/capecitabine) OR intolerable side effects caused by these standard treatment OR unmanageable carcinoid symptoms.
    4. WHO/ ECOG Performance Status of 0-2.
    5. Life expectancy > 6 months
    6. Uptake higher than liver in primary tumor or metastases on Ga-DOTATOC PET/CT (Krenning 3 or 4), if the scan is more than 3 months old at inclusion time, a new scan should be done.
    7. Adequate organ function as defined by:
    • Adequate kidney function: Standard glomerular filtration rate >30 ml/min/m2 measured by Tc-DTPA clearance
    • Adequate bone marrow function:
    • WBC ≥ 2.0 x 109/L
    • Platelets ≥ 100 x 109/L
    • Hb ≥ 6 mmol/l (≥9.67 g/dL )
    • No evidence of significant liver disease:
    • Serum bilirubin < 40 µmol/L
    • Albumin > 20g/L
    8. Willingness and ability to comply with scheduled visits for SPECT/CT scans, treatment plans, laboratory tests and other study procedures.
    9. Written informed consent obtained prior to any screening procedures
    E.4Principal exclusion criteria
    1. Tumor amenable to surgery and/or radiofrequency ablation.
    2. Patients who are unable to stay isolated for 24 hours
    3. Previous PRRT
    4. Female patients who are pregnant or lactating. Women who are of childbearing potential (defined as all women physiologically capable of becoming pregnant) have to practice an effective method of contraception/birth control. Fertile female patients have to take a urinary pregnancy test, to ensure that they are not pregnant, before they can enter the study. After entering the study, they have to use effective contraception during the study period and 6 months after. Effective contraception methods include:
    • Use of oral, injected or implanted hormonal methods of contraception or
    • Placement of an intrauterine device (IUD) or intrauterine system (IUS)
    • Barrier methods of contraception: condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository can be used if hormonal contraception is not tolerated. Both have to be used at the same time.
    • Total abstinence or patient sterilization (male or female)
    5. Male patients are not allowed to conceive pregnancy for 6 months after last treatment cycle
    6. Patients with meningioma
    E.5 End points
    E.5.1Primary end point(s)
    • Difference in progression free survival between NEN patients treated with dosimetry based versus standard PRRT. Defined as time from randomization to documented disease progression or death by any cause, evaluated by CT, RECIST 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after LPLV
    E.5.2Secondary end point(s)
    • Difference in tumor dose between dosimetry based and standard PRRT treatment groups
    • Difference in kidney toxicity between dosimetry based and standard PRRT treatment groups, measured by creatine, eGFR, cystatin-c, Tc-DTPA clearance, and kidney fibrosis markers PRO-6, C3M and LAMC1.
    • Difference in bone marrow function between dosimetry based and standard PRRT treatment groups, measured by hemoglobin, white blood cells, platelets.
    • Difference in subjective side effects between dosimetry based and standard PRRT treatment groups, evaluated by questionnaire.
    • Difference in quality of life between dosimetry based and standard PRRT treatment groups, evaluated by questionnaire EORTC QLQ-30 and QLQ-GI.NET21.
    • Difference in overall survival between dosimetry based and standard PRRT treatment groups.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Some can be evaluated right af LPLV and some several year after depending on how long the patients survive.
    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 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 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 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 Yes
    E.8.2.3.1Comparator description
    Standard dose vs dosimetry based dose
    E.8.2.4Number of treatment arms in the trial2
    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
    The study is estimated to end 5 years after FPFV. Inclusion is estimated to take 3.5 years.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state100
    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)
    They will follow normal follow-up after PRRT
    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 Decision2019-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-16
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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