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    The EU Clinical Trials Register currently displays   36373   clinical trials with a EudraCT protocol, of which   5993   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-002867-41
    Sponsor's Protocol Code Number:OPS-C-001/D-FR-01072-001
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2016-05-11
    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 number2015-002867-41
    A.3Full title of the trial
    An international multi-center, open-label study to evaluate safety, tolerability, biodistribution, dosimetry and preliminary efficacy of 177Lu-OPS201 for the therapy of somatostatin receptor positive neuroendocrine tumours (NETs).

    (Sub-study of Master Protocol Ipsen 001Version 1.0: 02 February 2018)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An international multi-center, open-label study to evaluate safety, tolerability, biodistribution (distribution in the body), dosimetry (to calculate the radiation exposure of patients) and preliminary efficacy of 177Lu-OPS201 for the therapy of somatostatin receptor positive neuroendocrine tumours (NETs).
    A.4.1Sponsor's protocol code numberOPS-C-001/D-FR-01072-001
    A.5.4Other Identifiers
    Name:ClinicalTrials.gov Identifier (NCT number)Number:NCT02592707
    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 SponsorIpsen Pharma
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIpsen Pharma
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIpsen Pharma
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address65, quai Georges Gorse
    B.5.3.2Town/ cityBoulogne-Billancourt
    B.5.3.3Post code92100
    B.5.3.4CountryFrance
    B.5.4Telephone number+3316092 2000
    B.5.5Fax number+3316907 2802
    B.5.6E-mailct-application@ipsen.com
    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-OPS201 - 177Lu-satoreotide tetraxetan
    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 INNN/A
    D.3.9.1CAS number 14265-75-9
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameLUTETIUM, ISOTOPE OF MASS 177
    D.3.9.4EV Substance CodeSUB38329
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsatoreotide tetraxetan
    D.3.9.1CAS number 1039726-31-2
    D.3.9.2Current sponsor codeOPS201
    D.3.9.3Other descriptive nameOPS201
    D.3.9.4EV Substance CodeSUB182340
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number250 to 350
    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.IMP: 2
    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-OPS201 - 177Lu-satoreotide tetraxetan
    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 INNN/A
    D.3.9.1CAS number 14265-75-9
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameLUTETIUM, ISOTOPE OF MASS 177
    D.3.9.4EV Substance CodeSUB38329
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsatoreotide tetraxetan
    D.3.9.1CAS number 1039726-31-2
    D.3.9.2Current sponsor codeOPS201
    D.3.9.3Other descriptive nameOPS201
    D.3.9.4EV Substance CodeSUB182340
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number250 to 350
    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.IMP: 3
    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-OPS201 - 177Lu-satoreotide tetraxetan
    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 INNN/A
    D.3.9.1CAS number 14265-75-9
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameLUTETIUM, ISOTOPE OF MASS 177
    D.3.9.4EV Substance CodeSUB38329
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsatoreotide tetraxetan
    D.3.9.1CAS number 1039726-31-2
    D.3.9.2Current sponsor codeOPS201
    D.3.9.3Other descriptive nameOPS201
    D.3.9.4EV Substance CodeSUB182340
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number250 to 350
    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.IMP: 4
    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-OPS201 - 177Lu-satoreotide tetraxetan
    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 INNN/A
    D.3.9.1CAS number 14265-75-9
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameLUTETIUM, ISOTOPE OF MASS 177
    D.3.9.4EV Substance CodeSUB38329
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsatoreotide tetraxetan
    D.3.9.1CAS number 1039726-31-2
    D.3.9.2Current sponsor codeOPS201
    D.3.9.3Other descriptive nameOPS201
    D.3.9.4EV Substance CodeSUB182340
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number550 to 850
    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.IMP: 5
    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-OPS201 - 177Lu-satoreotide tetraxetan
    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 INNN/A
    D.3.9.1CAS number 14265-75-9
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameLUTETIUM, ISOTOPE OF MASS 177
    D.3.9.4EV Substance CodeSUB38329
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsatoreotide tetraxetan
    D.3.9.1CAS number 1039726-31-2
    D.3.9.2Current sponsor codeOPS201
    D.3.9.3Other descriptive nameOPS201
    D.3.9.4EV Substance CodeSUB182340
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number550 to 850
    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.IMP: 6
    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-OPS201 - 177Lu-satoreotide tetraxetan
    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 INNN/A
    D.3.9.1CAS number 14265-75-9
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameLUTETIUM, ISOTOPE OF MASS 177
    D.3.9.4EV Substance CodeSUB38329
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsatoreotide tetraxetan
    D.3.9.1CAS number 1039726-31-2
    D.3.9.2Current sponsor codeOPS201
    D.3.9.3Other descriptive nameOPS201
    D.3.9.4EV Substance CodeSUB182340
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number550 to 850
    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.IMP: 7
    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-OPS201 - 177Lu-satoreotide tetraxetan
    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 INNN/A
    D.3.9.1CAS number 14265-75-9
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameLUTETIUM, ISOTOPE OF MASS 177
    D.3.9.4EV Substance CodeSUB38329
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsatoreotide tetraxetan
    D.3.9.1CAS number 1039726-31-2
    D.3.9.2Current sponsor codeOPS201
    D.3.9.3Other descriptive nameOPS201
    D.3.9.4EV Substance CodeSUB182340
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1100 to 1500
    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.IMP: 8
    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-OPS201 - 177Lu-satoreotide tetraxetan
    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 INNN/A
    D.3.9.1CAS number 14265-75-9
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameLUTETIUM, ISOTOPE OF MASS 177
    D.3.9.4EV Substance CodeSUB38329
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsatoreotide tetraxetan
    D.3.9.1CAS number 1039726-31-2
    D.3.9.2Current sponsor codeOPS201
    D.3.9.3Other descriptive nameOPS201
    D.3.9.4EV Substance CodeSUB182340
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1100 to 1500
    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.IMP: 9
    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-OPS201 - 177Lu-satoreotide tetraxetan
    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 INNN/A
    D.3.9.1CAS number 14265-75-9
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameLUTETIUM, ISOTOPE OF MASS 177
    D.3.9.4EV Substance CodeSUB38329
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsatoreotide tetraxetan
    D.3.9.1CAS number 1039726-31-2
    D.3.9.2Current sponsor codeOPS201
    D.3.9.3Other descriptive nameOPS201
    D.3.9.4EV Substance CodeSUB182340
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1100 to 1500
    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
    Neuroendocrine tumors (NETs)
    E.1.1.1Medical condition in easily understood language
    Neuroendocrine tumors (NETs), neoplasms that arise from cells of the endocrine (hormonal) and nervous systems.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    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
    To assess the safety and tolerability of peptide receptor radionuclide therapy (PRRT) with 177Lu-OPS201 administered in three cycles in patients with somatostatin receptor (sstr) 2 positive NETs (including phaechromocytomas and paragangliomas).
    E.2.2Secondary objectives of the trial
    •To evaluate the optimal radioactivity and peptide mass dose to be used in future studies

    •To characterise 177Lu-OPS201 whole body biodistribution and pharmacokinetics of the radiopharmaceutical after each administration of 177Lu-OPS201.

    •To determine the radiation dosimetry of 177Lu-OPS201 (organ exposure to administered radioactivity) after each administration of 177Lu-OPS201 with three different peptide mass doses.

    •To undertake a preliminary assessment of the therapeutic efficacy of 177Lu-OPS201 PRRT by determination of RECIST v1.1 status. The progression free survival (PFS) will be evaluated in Long-term Follow-up Visits up to 2 years after the end of core-trial (EOCT) Visit.

    • To evaluate the response to treatment by assessing changes in tumour volume.

    •To evaluate the influence of 177Lu-OPS201 PRRT on the subject´s Quality of Life.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent
    2. Subjects of either gender, aged ≥ 18 years
    3. Women of childbearing potential (not surgically sterile or less than 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 6 months after the last dose. Acceptable methods of contraception include abstinence, or double contraception: steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method (intrauterine device, condom etc.).
    4. Male subjects must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 6 months after the last activity administration.
    5. Karnofsky performance score ≥ 60
    6. Life expectancy of at least 6 months
    7. Histologically confirmed diagnosis of
    - unresectable GEP NET (Grade I and Grade II according to WHO classification (2010), functioning and nonfunctioning)
    - unresectable lung NET Grade I and Grade II (low and intermediate grade) (Klimstra et al 2010)
    - unresectable " typical lung carcinoid" or "atypical lung carcinoid" are acceptable (with the exception of Large Cell Bronchila Neuroendocrine Neoplasms and Small Cell Lung Cancers (Caplin 2015).
    - malignant, unresectable pheochromocytoma or paraganglioma
    - subjects, who have histologically confirmed NET, but no clear localization of their primary tumor can be included.
    8. Documentation of progressive disease based on RECIST v1.1 under prior anti-tumor therapy within 6 months of Visit 1 Day 1 (although the progression might have occured more than 6 months before Visit 1 Day 1). Subjects should not have received further anti-tumor therapy once disease progression is documented. All images should be sent to the imaging core laboratory.
    9. In countries where sunitinib or everolimus are marketed, subjects with GEP NET and lung NET will be progressive under this prior anti-tumor treatment for the respective indication. Subjects not suitable for everolimus/sunitinib therapy according to a tumor board decision (or comparable local practice) may also be enrolled into the study. Subjects having everolimus/sunitinib therapy should have a wash-out phase of ≥ 4 weeks before the first treatment.
    10. Measurable disease based on RECIST v1.1.
    11. For Part A: Confirmed presence of somatostatin receptors on technically evaluable tumor lesions documented by a positive SRS* performed within 6 months prior of Visit 1 Day 1

    * presence of at least one lesion that is ≥ 20 mm in the longest dimension (as measured on correlative CT or MRI) and with a maximum Standardized Uptake Value (SUVmax) of ≥ 2x the SUVmean of the liver background on 68Ga-PET imaging or a score of “3” or “4” according to the Krenning scale on 111In-SPECT Imaging.

    For Part B: Confirmed presence of sstr on technically evaluable tumour lesions documented by a positive SRS*. If this has not been performed within 6 months of Visit 1 Day 1, then it must be repeated during screening.

    *presence of at least two lesions that are ≥20 mm in the longest Dimension (as measured on correlative CT or MRI) with a maximum standardized uptake value (SUVmax) of ≥ 2x the SUVmean of the liver background on 68Ga-PET imaging or a score of “3” or “4” according to the Krenning scale on SPECT Imaging.

    12. Calculated glomerular filtration rate (GFR) ≥ 55 mL/min
    13. Blood test results as follows:
    a. Leukocytes: ≥ 4*10^9/L
    b. Erythrocytes: ≥ 3.5*10^12/L
    c. Platelets: ≥ 100*10^9/L
    d. Albumin: > 30 g/L
    e. ALT, AST, AP: ≤ 5 times upper limit of normal (UNL)
    f. Bilirubin: ≤ 3 times ULN (2x 1.1 mg/dL)
    E.4Principal exclusion criteria
    1. Known hypersensitivity to 177Lu, DOTA, JR11 or to any of the excipients of 177Lu-OPS201.
    2. Any previous PRRT.
    3. Diagnosis of thymic NET.
    4. Presence of active infection at screening, or history of serious infection within the previous 6 weeks.
    5. Administration of any other investigational medicinal product (IMP) within 60 days prior to entry (Visit 1 Day 1).
    6. Prior or planned administration of a therapeutic radiopharmaceutical within 8 half-lives of the radionuclide including any time during the current study.
    7. Any extensive radiotherapy ≤ 3 months before first IRPP administration
    8. Chemotherapy ≤ 3 months before first IRPP Administration
    9. For Part B: Nephrectomy, renal transplant or concomitant nephrotoxic therapy putting the subject at high risk of renal toxicity during the study as assessed by the investigator
    10a. Pregnant or breast-feeding women. A serum pregnancy test will be performed at the start of the study for all female subjects of childbearing potential (i.e. not surgically sterile or up to 2 years postmenopausal).
    11. Any uncontrolled significant medical, psychiatric or surgical condition (active infection (including subject with known hepatitis B or hepatitis C and subjects with known human immunodeficiency virus (HIV) positive), unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, poorly controlled diabetes mellitus (glycated haemoglobin (HbA1c) ≥9%), uncontrolled congestive heart disease, etc.) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety or that would limit compliance with the objectives and assessments of the study. Note: the subject should be able to tolerate high volume load.
    12. Current history of any malignancy other than NET within 5 years of enrolment except for fully-resected non-melanoma skin cancer or cervical cancer in situ
    13. Any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and Tolerability
    Frequencies and/or descriptive summaries of standard safety and tolerability parameters: AEs (including SAEs) according to National Cancer Institute (NCI) common
    terminology criteria for adverse Events (CTCAE) v5.0 and serious adverse events (SAEs), vital signs, laboratory tests (haematology, biochemistry and urinalysis, and pituitary markers), 12 lead and Holter electrocardiogram (ECG), DLTs, physical examination results and
    use of concomitant medication throughout the study.


    E.5.1.1Timepoint(s) of evaluation of this end point
    At all visits during the study; AE and SAE reporting during the whole course of the study subsequently after occurance. 24 hour holter ECG starting with each PRRT treatment procedure on Visit 1-3 (and optional 2 visits) day 1.
    E.5.2Secondary end point(s)
    Biodistribution and Pharmacokinetics of the Radiopharmaceutical Endpoints:
    • maximal uptake (%) at the target lesion
    • maximal uptake (%) in discernible organs and blood
    • AUC of 177Lu OPS201 in discernible thoracic and abdominal organs, target lesion and blood.
    • Terminal half-life of radioactivity concentrations of the radiopharmaceutical in blood.

    Radiation Dosimetry Endpoints:
    • Organs receiving the highest absorbed dose.
    • Specific absorbed dose to the target lesion (Gy/GBq)
    • Specific absorbed dose per organ (Gy/GBq).
    • Cumulative absorbed organ doses (Gy).

    OPS201 Pharmacokinetics Endpoints:
    • If OPS201 levels are measurable in plasma and urine, pharmacokinetic parameters of OPS201 (including, but not limited to, Cmax, AUC, t1/2, CL, Vd, cumulative amount of unchanged drug excreted into the urine (Ae) and renal clearance of the drug from plasma (CLR)) will be derived using a non-compartmental approach on the individual plasma concentration-time profiles of OPS201 and on the individual urine concentrations.
    An attempt to build an integrated model taking into account PK, dosimetry as well as efficacy and safety data will be made if warranted by the data.

    Preliminary Therapeutic Efficacy (tumor response)
    • Tumor response based on RECIST v1.1 at EOTC
    • Monitoring of PFS as determined from start of study treatment until occurrence of tumour progression or death, for 2 years after the EOCT (based on RECIST v1.1 status)
    • evaluation of tumour change in volume from baseline to EOCT based on the target lesions selected by RECIST.
    Influence of 177Lu-OPS201 PRRT on the Quality of Life:
    • Quality of Life Questionnaire (QLQ-C30; GI.NET21) change from
    baseline to EOCT
    E.5.2.1Timepoint(s) of evaluation of this end point
    Biodistribution and Pharmacokinetics:
    After each PRRT-cycle

    Radiation Dosimetry:
    After each PRRT-cycle

    Pharmacokinetics:
    After each PRRT-cycle

    Preliminary Therapeutic Efficacy (tumor response)
    Screening visit, each cycle of therapy, EOCT visit, each long-term FU visit

    Influence of 177Lu-OPS201 PRRT on the Quality of Life of the patients
    At Visit 1,2,3 and EOCT visit
    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 Yes
    E.6.13.1Other scope of the trial description
    Radiation Dosimetry of 177Lu-OPS201
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    First sponsor initiated clinical phase I/II trial
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA7
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Canada
    Denmark
    France
    Switzerland
    United Kingdom
    United States
    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
    Last long-term follow-up visit of the last patient
    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 months3
    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 months3
    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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 27
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 27
    F.4.2.2In the whole clinical trial 55
    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. At the discretion of the treating physician.
    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 Decision2016-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-25
    P. End of Trial
    P.End of Trial StatusRestarted
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