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    Summary
    EudraCT Number:2017-003432-37
    Sponsor's Protocol Code Number:A005D-E01-201
    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:2017-11-17
    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 number2017-003432-37
    A.3Full title of the trial
    Phase II study of preliminary diagnostic performance of [68Ga]-NeoBOMB1 in adult patients with malignancies known to overexpress Gastrin Releasing Peptide Receptor
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of [68Ga]-NeoBOMB1 imaging in patients with malignancies known to overexpress GRPR
    A.3.2Name or abbreviated title of the trial where available
    Neo-FIND
    A.4.1Sponsor's protocol code numberA005D-E01-201
    A.5.4Other Identifiers
    Name:Not applicableNumber:Not applicable
    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 SponsorAdvanced Accelerator Applications International SA
    B.1.3.4CountrySwitzerland
    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 supportAdvanced Accelerator Applications International SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAdvanced Accelerator Applications International SA
    B.5.2Functional name of contact pointClinical trial team
    B.5.3 Address:
    B.5.3.1Street Address4, Rue de la Tour de l'ile
    B.5.3.2Town/ cityGeneva
    B.5.3.3Post code1204
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41 22519 28 41
    B.5.5Fax number+33(0)450993071
    B.5.6E-mailinfomed@adacap.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1794
    D.3 Description of the IMP
    D.3.1Product name[68Ga]-NeoBOMB1 50 µg, kit for radiopharmaceutical preparation
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Kit for radiopharmaceutical preparation
    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 INNNeoBOMB1
    D.3.9.3Other descriptive nameDOTA-PABZA-DIG-dPhe-Gln-Trp-Ala-Val-Gly-His-NHCH[CH2CH(CH3)2]2
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Malignancies known to overexpress Gastrin-Releasing Peptide Receptors
    E.1.1.1Medical condition in easily understood language
    Breast, Prostate, Lung (non-small cell and small-cell) and Colo-rectal cancers
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10041067
    E.1.2Term Small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    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 characterize preliminary targeting properties of [68Ga]-NeoBOMB1 in patients with malignancies known to overexpress GRPR.
    E.2.2Secondary objectives of the trial
    •To assess safety and tolerability of a single diagnostic dose of [68Ga]-NeoBOMB1 administered as an intravenous bolus injection.
    •To assess the bio-distribution, pharmacokinetics, radiation dosimetry, and absorbed doses in critical organs for [68Ga]-NeoBOMB1 in a limited set of patients.
    •To establish the optimal threshold, expressed as Standardized Uptake Value (SUV), to discriminate Positron Emission Tomography (PET) imaging positive results from negative ones.
    •To estimate the [68Ga]-NeoBOMB1 PET imaging performance lesion-based and patient-based relative to a comparable standard imaging practice (eg PET, CT) according to the tumour type.
    •To estimate the [68Ga]-NeoBOMB1 PET diagnostic performance lesion-based and patient-based relative to the GRPR histopathology findings (e.g. IHC)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Subjects must be at least 18 years of age
    •Subjects must have signed and dated an informed consent prior to any study-specific procedures.
    •Subjects with histologically-confirmed tumour, for whom a less than 6-month-old biopsy has been performed.
    •Dosimetry group:
    -Luminal breast cancer
    -Adenocarcinoma of the prostate
    •Non-dosimetry group:
    -Luminal breast cancer
    -Adenocarcinoma of the prostate
    -Small-cell lung cancer
    -Non-small cell lung cancer
    -Colorectal carcinoma
    •At least one malignant lesion detected via functional or morphological imaging (PET combined to appropriate tracer according to tumour type, CT, MRI) within 3 months prior to the administration of [68Ga]-NeoBOMB1.
    •The Eastern Cooperative Oncology (ECOG) performance status 0-2.
    •Subjects must agree to use highly effective methods of contraception (female partners of male participants should use highly effective methods of contraception) during the trial.
    E.4Principal exclusion criteria
    •Renal insufficiency or an estimated Glomerular Filtration Rate (eGFR) <50 ml/min/1.73 m2.
    •Haematological toxicity grade > 2 (Toxicity Grading Scale in vaccine clinical trials)
    •Participation in any other investigational trial within 30 days of study entry.
    •Subjects with positive pregnancy test (Urine dipstick), and/or currently breast-feeding
    •Concurrent severe illness or clinically relevant trauma within 2 weeks before the administration of the investigational product that might preclude study completion or interfere with study results.
    •Concurrent bladder outflow obstruction or unmanageable urinary incontinence.
    •Known or expected hypersensitivity to 68Gallium, NeoBOMB1, or any excipient present in [68Ga]-NeoBOMB1.
    •Any condition that precludes raised arms position
    •Prior administration of a radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide.
    •History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
    E.5 End points
    E.5.1Primary end point(s)
    •Number and location of tumour lesions detected by [68Ga]-NeoBOMB1 overall and for each tumour type
    •Calculation of the ratio tumour/background SUV and calculation of percentage absorbed dose in tumour overall and for each tumour type.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Immediately after radiotracer injection, 4 scans with 6-7 bed positions will be acquired at approximately 15min, 1h±15min, 2h±15min and 4h±30min p.i. CT low dose attenuation scans will be acquired after every PET scan. PET data will be corrected for photon attenuation, dead-time, random events and scatter. A whole-body high dose CT will be acquired only if the conventional imaging of the patient is older than 1 month.

    Patients of the non-dosimetry group will undergo 2 whole-body PET/CT scans at 90±30 min and at 150±30 min. Patients with prostate cancer will also undergo a 5-min static PET/CT scan on relevant regions for lymph node imaging purpose. A whole-body high dose CT will be acquired only if the conventional imaging of the patient is older than 4 weeks.
    E.5.2Secondary end point(s)
    •Standard safety parameters (clinical monitoring, laboratory, ECG)
    •Tolerability and safety of the administration of a diagnostic dose of [68Ga]-NeoBOMB1 in patients with malignancies known to overexpress GRPR as determined by absence of:
    -increased number of SAEs compared to other peptide-based radiotracers;
    -clinically relevant changes of physiological parameters (blood pressure, heart rate, ECG findings)
    •Generation of decay corrected tissue TACs from [68Ga]-NeoBOMB1 PET/CT images in normal organs, tumour lesions.
    •Quantification of urinary excretion of [68Ga]-NeoBOMB1
    •Calculation of half-life of [68Ga]-NeoBOMB1 in blood
    •Generation of non-decay-corrected time activity curves from [68Ga]-NeoBOMB1 PET/CT images in normal organs, tumour lesions
    •Calculation of residence times in organs and tumour lesions of [68Ga]-NeoBOMB1
    •Calculation of absorbed doses and effective whole body dose of [68Ga]-NeoBOMB1
    •Calculation of the SUV of each lesion
    •Number and location of tumour lesion detected by [68Ga]-NeoBOMB1 in comparison with comparable standard imaging modalities such as FDG-PET
    •Calculation of the [68Ga]-NeoBOMB1 PET overall, positive and negative agreement on a lesion-by-lesion basis as well as on a patient basis relative to the standard imaging overall and for each tumour type
    •Comparison of number of patients with tumour lesions detected and number of tumour lesions detected by [68Ga]-NeoBOMB1 with cytology and/or histopathology from archival and/or recent biopsy specimens
    •Calculation of the [68Ga]-NeoBOMB1 PET sensitivity and specificity on a lesion-by-lesion basis for all lesions with associated biopsy data, and on a patient basis relative to histopathology / cytology data
    E.5.2.1Timepoint(s) of evaluation of this end point
    Immediately after radiotracer injection, 4 scans with 6-7 bed positions will be acquired at approximately 15min, 1h±15min, 2h±15min and 4h±30min p.i. CT low dose attenuation scans will be acquired after every PET scan. PET data will be corrected for photon attenuation, dead-time, random events and scatter. A whole-body high dose CT will be acquired only if the conventional imaging of the patient is older than 1 month.

    Venous whole blood samples will be collected at pre-dose (0), 5, 10, 20, 30±5, 60±5 min, and at 2h±10 min and 3-4 h±10 min p.i. Urine samples from 0-2 h and from 2-4 h p.i. will also be collected.
    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 No
    E.6.6Pharmacokinetic Yes
    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 EEA4
    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 end of the trial will occur within maximum one month after the data base lock.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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 Decision2018-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-07-05
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