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    Summary
    EudraCT Number:2018-000028-33
    Sponsor's Protocol Code Number:D-FR-01070-003
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-04-06
    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 ConcernedAustria - BASG
    A.2EudraCT number2018-000028-33
    A.3Full title of the trial
    A non-randomised, phase II study to evaluate the optimal uptake time of 68Ga-OPS202 as a sstr2 positive PET imaging agent in subjects with newly diagnosed breast cancer.
    (Sub-study of Master Protocol Ipsen 001 Version 1.0: 02 February 2018)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A non-randomised, phase II study to evaluate the optimal uptake time of 68Ga-OPS202 as a sstr2 positive PET (Positron Emission Tomography) imaging agent in subjects with newly diagnosed breast cancer.
    A.4.1Sponsor's protocol code numberD-FR-01070-003
    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+33158 33 50 00
    B.5.5Fax number+33158 33 50 01
    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 name68Ga-OPS202
    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 INNsatoreotide trizoxetan
    D.3.9.1CAS number 2028265-17-8
    D.3.9.2Current sponsor codeOPS202 acetate - NODAGA-JR11
    D.3.9.3Other descriptive nameSATOREOTIDE TRIZOXETAN
    D.3.9.4EV Substance CodeSUB186021
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 45
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameGALLIUM 68(68-GA)
    D.3.9.4EV Substance CodeSUB126249
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150 to 200
    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
    Breast Cancer
    E.1.1.1Medical condition in easily understood language
    Breast Cancer
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10057654
    E.1.2Term Breast cancer female
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To evaluate the percentage of women with newly diagnosed breast cancer who have sstr2 positive lesions that are identified using 68Ga-OPS202
    - To define the optimal PET imaging time of 68Ga-OPS202 at 0.5, 1.0 and 2 hours post injection, based on detected lesions in adult women with sstr2 positive newly diagnosed early or advanced breast cancer
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    - To further define the optimal uptake time of 68Ga-OPS202 based on quantitative SUVmax and other quality parameters
    - To describe the safety and tolerability of 68Ga-OPS202 in women with newly diagnosed (early or advanced) sstr2 positive breast cancer

    Exploratory objectives:
    - To provide preliminary estimates of the sensitivity of 68Ga-OPS202 PET/CT scan imaging, as well as SUV ratio (SUVmax lesion/SUVmean reference tissue) and signal-to- noise ratios (SNR)
    - To assess the correlation in terms of number of avid lesions between
    18F-fluorodeoxyglucose (18F-FDG)-PET and 68Ga-OPS202
    - To assess the correlation between 68Ga-OPS202 tumour uptake with results from immunohistochemistry staining of sstr2.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Women aged 18 years or older
    (2) Subjects with newly diagnosed (early or advanced) breast cancer
    (3) Eastern Cooperative Oncology Group (ECOG) performance status ≤2
    (4) Adequate bone marrow, liver and renal function, with:
    • Calculated glomerular filtration rate (GFR): ≥45 mL/min
    • Albumin: >30 g/L
    • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP): ≤5 times upper limit of normal (ULN)
    • Bilirubin: ≤3xULN (3×1.1 mg/dL)
    • Leukocytes: ≥3x109/L, and neutrophils: ≥1x109/L
    • Erythrocytes: ≥3.5x1012/L
    • Platelets: ≥90x109/L
    (5) Signed written informed consent prior to any study-related procedures
    E.4Principal exclusion criteria
    (1) Subject with resected primary tumour
    (2) Subjects with confirmed ductal carcinoma in situ
    (3) Men with breast cancer
    (4) Presence of an active infection at screening or history of a serious infection within the previous 6 weeks prior to the first 68Ga-OPS202 administration that might interfere with the PET and/or CT analysis
    (5) Subjects who have received any therapy for breast cancer
    (6) Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide
    (7) Clinically relevant trauma within 2 weeks prior to first 68Ga-OPS202 administration
    (8) Any condition that precludes the proper performance of PET and/or CT scan:
    • Subjects who are not able to tolerate the CT contrast agent
    • Subjects with metal implants or arthroplasty, or any other objects that might interfere with the PET and/or CT analysis
    • Subjects unable to raise arms for prolonged imaging purposes
    • Subjects unable to lie still for the entire imaging time
    • Subjects weighing greater than 110 kg (243 lb)
    (9) Known hypersensitivity to radiolabelled NODAGA (1,4,7-triazacyclononane,1-glutaric acid 4,7 acetic acid), to Gallium-68, to somatostatin analogue peptide JR11 or to any of the excipients of 68Ga-OPS202
    (10) History of, or current active allergic or autoimmune disease, including asthma or any condition requiring long-term use of systemic corticosteroids
    (11) Known human immunodeficiency virus (HIV) or positive serology for HIV, hepatitis B or C
    (12) Administration of another investigational medicinal product within 30 days prior to first
    68Ga-OPS202 administration
    (13) Subjects who are pregnant, breast feeding or of childbearing potential not willing to practice effective contraceptive techniques during the study treatment period and for
    30 days after the last dose of 68Ga-OPS202 administration; pregnancy test must be performed at the start of the study and prior to 68Ga OPS202 administration
    (14) Subjects who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including 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
    (15) Subject who experienced a previous cancer (except basocellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus, and/or subjects treated with curative intent and free from disease for more than 5 years)
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    - Percentage of subjects with sufficiently avid lesion(s) to be identified as a sstr2 positive lesion. (Avid is defined by the blinded readers at one of the acquisition timepoints as an easily identifiable lesion radiologically, where there has been clear focal uptake of 68Ga-OPS202 and 1.5-fold or greater uptake than the non-tumoural liver and lung parenchyma).
    - Differences in the number of lesions detected by 68Ga-OPS202 between the three PET acquisition timepoints (0.5, 1 and 2 hours), and reader interpretation of optimal image(s) in the primary breast lesions.
    E.5.1.1Timepoint(s) of evaluation of this end point
    68Ga-OPS202 PET/CT imaging will be taken at Visit 2:
    - PET acquisition at 0.5, 1 and 2 hours after 68Ga-OPS202 administration,
    - the single ceCT required for the study can be acquired after either of the 2 PET scan (18F-FDG-PET or 68Ga OPS202 post the 2-hour acquisition). Low-dose CT scans will be acquired for the other PET scans when the ceCT is not obtained.
    E.5.2Secondary end point(s)
    I - Secondary endpoints

    Key secondary:
    • Differences in the number of lesions detected by 68Ga-OPS202 between the three PET acquisition timepoints (0.5, 1 and 2 hours), and reader interpretation of optimal image(s) in nodular and metastatic lesions. Significant uptake of 68Ga-OPS202 for the evaluation of a lesion is an avid lesion defined by the blinded readers at one of the acquisition timepoints as an easily identifiable lesion radiologically, where there has been clear focal uptake of 68Ga OPS202 and 1.5-fold or greater uptake than in the non-tumoural liver and lung parenchyma.
    • The SUVmean and SUVmax in the primary lesion between each of the three timepoints, measured in the most avid lesions (using the 68Ga-OPS202 scans). This is assessed by the tumour-to-background ratio in the primary tumour and each of the major anatomic sites (liver, lymph nodes, bone, lungs and brain); the background consists of non tumoural liver parenchyma or aortic blood where sufficient liver is not available. Identification of lesions to be used will be made by one of the two primary readers.

    Other secondary:
    • Differences in relative lesion counts as a ratio of the number of lesions detected by 68Ga-OPS202 at 0.5, 1 and 2 hours post dose respectively, compared to the number of lesions assessed by standard-of-truth (descriptive analyses). The standard-of-truth is the 18F-FDG-PET/CT scan images acquired at any time during the study period (including the Screening period). This will be calculated by (number of lesions detected by
    68Ga-OPS202)/(number of lesions detected by 18F-FDG-PET).
    • Differences of absolute number of lesions between the three PET acquisition timepoints detected in each of the following anatomic sites:
    - Lymph nodes
    - Liver
    - Axial/appendicular skeleton
    - Lungs
    - Brain

    II - Safety endpoints
    • Proportion of subjects experiencing at least one AE of any grade according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI- CTCAE) version 4.03, including any serious AEs including suspected unexpected serious adverse reactions (SUSARs); all AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) and preferred term (PT) (as per most recent version)
    • Proportion of subjects experiencing at least one AE of grade ≥3 according to NCI CTCAE.
    • Clinically significant changes in physical examination, vital signs, ECG and laboratory findings, which will be recorded by the investigator as AEs.
    • Use of concomitant medication

    III - Exploratory endpoints
    • Preliminary diagnostic sensitivity of 68Ga-OPS202 imaging of breast cancer expressing sstr2 positive by both subject-based and lesion-based analysis compared to standard-of- truth
    • SNR calculated from lesion-free volume of interest (VOI) in the liver: SUVmean/SUVSD at the three PET acquisition timepoints
    • Estimated correlation in terms of number of avid lesions between 68Ga-OPS202 PET at the agreed “optimum timepoint” and 18F-FDG-PET
    • Estimated correlation between 68Ga-OPS202 PET uptake and results of immunohistochemistry staining of sstr2 of the primary tumour.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 68Ga-OPS202 PET/CT at Visit 2:
    o PET at 0.5, 1 and 2 hours after 68Ga-OPS202 administration,
    o ceCT after either of the 2 PET (18F-FDG-PET or 68Ga OPS202 post 2-hour acquisition). Low-dose CT will be acquired for the other PET when the ceCT is not obtained.
    - Tumor biopsy will be performed (if not already done) at Visit 1 (Day -14 to Day -1).
    - 18F-FDG-PET scan: any time during the study period
    - Haematology: Visits 1, 2 & 3
    - Blood chemistry: Visits 1, 2 & 3
    - Urinalysis: Visits 1, 2 & 3
    - ECG: Visits 1 & 3
    - Physical examination: Visits 1, 2 & 3
    - Vital signs: Visits 1, 2 & 3 (0.5, 1, 2 and 4 hours post injection)
    - Adverse events: all through study participation
    - Concomitant therapies: From 3 months prior to injection, Visits 1, 2 & 3
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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: 41
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 54
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-08-09
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