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    The EU Clinical Trials Register currently displays   44293   clinical trials with a EudraCT protocol, of which   7351   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-003805-71
    Sponsor's Protocol Code Number:ICO-2020-25
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-15
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-003805-71
    A.3Full title of the trial
    Prospective phase II pilot study, assessing imaging performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT in metastatic triple negative breast cancer patients
    OPALESCENCE: zircOn PET-CT imAging TLX mEtaStatiC triplE Negative CancEr
    Étude Pilote prospective de phase II, évaluant les performances de l’examen TEP/TDM au Girentuximab marqué au 89Zirconium (89Zr-TLX250) chez des patient(e)s atteint(e)s d’un cancer du sein Triple Négatif
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective phase II pilot study, assessing imaging performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT in metastatic triple negative breast cancer patients
    A.3.2Name or abbreviated title of the trial where available
    OPALESCENCE
    A.4.1Sponsor's protocol code numberICO-2020-25
    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 SponsorINSTITUT DE CANCEROLOGIE DE L'OUEST
    B.1.3.4CountryFrance
    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 supportSIRIC ILIAD NANTES ANGERS
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportTELIX PHARMACEUTICALS
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINSTITUT DE CANCEROLOGIE DE L'OUEST
    B.5.2Functional name of contact pointClinical Research Dept- Promotion R
    B.5.3 Address:
    B.5.3.1Street AddressBD JACQUES MONOD
    B.5.3.2Town/ citySAINT HERNLAIN
    B.5.3.4CountryFrance
    B.5.4Telephone number+33240679908
    B.5.5Fax number33240679787
    B.5.6E-mailpromotionrc@ico.unicancer.fr
    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.2.1.2Country which granted the Marketing AuthorisationFrance
    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 name89 Zirconium-Girentuximab
    D.3.2Product code 89Zr-TLX250
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 Triple Negative Breast Cancer recurrence
    E.1.1.1Medical condition in easily understood language
    Patients with Triple Negative Breast Cancer recurrence
    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 10075566
    E.1.2Term Triple negative breast 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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the concordance for tumor lesion detection using 89Zr-TLX250 PET/CT versus a conventional 18FDG PET/CT scan where comparison will be made on a per lesion analysis basis
    E.2.2Secondary objectives of the trial
    1. To determine the percent of total tumor burden (whole body) detected on 89Zr-TLX250 PET/CT scan compared to that defined on 18FDG PET/CT used as the reference.
    2. To assess the correlation between the normalized uptake values (SUV) of 89Zr-TLX250 and CAIX histological expression if a biopsy is done.
    3. To confirm the perfect safety and tolerability of 89Zr-TLX250 and assess the generation of human anti-chimeric antibodies in response to the girentuximab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
    2. Female or male, Age ≥ 18 years at time of study entry.
    3. Primitive triple negative breast cancer proven histologically, defined according to the following criteria:
    - Estrogen receptors <10%.
    - And progesterone receptors <10%.
    - And HER2 not amplified or not overexpressed.
    4. BC recurrence documented by conventional imaging and/or FDG PET/CT with at least one metastasis measurable according to RECIST and/or PERCIST.
    5. Consent to use a contraception method for at least 30 days after administration of 89Zr-TLX250.
    6. ECOG Performance Status 0 or 1.
    7. Life expectancy at least 6 months.
    8. Patient has valid health insurance.
    9. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
    E.4Principal exclusion criteria
    1. History of another primary malignancy except for basal cell carcinoma within the last 5 years.
    2. Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the planned administration of 89Zr-TLX250 or continuing adverse effects (> grade 1) from such therapy (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0).
    3. Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).
    4. Exposure to murine or chimeric antibodies within the last 5 years.
    5. Previous administration of any radionuclide within 10 half-lives of the same.
    6. Impossibility to hold lying motionless at least 1 hour, or known claustrophobia.
    7. Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the subject, as judged by the investigator.
    8. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
    9. Pregnant or likely to be pregnant or nursing patient.
    10. Known hypersensitivity to girentuximab or desferoxamine.
    11. Renal insufficiency with GFR ≤ 45 mL/min/ 1.73 m².
    12. Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian.
    13. Disorder precluding understanding of trial information or informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    Concordance study of metastatic uptake seen in 18FDG PET/CT scan and 89Zr-TLX250 PET/CT scan per "lesion" by comparing for each lesion the CT scan, 18FDG PET/CT scan and 89Zr-TLX250 PET/CT scan by assessing a ratio "Number of positive 89Zr-TLX250 lesions / Number of positive FDG lesions” and "Number of positive 89Zr-TLX250 lesions / Number of CT scan lesions”.
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 days
    E.5.2Secondary end point(s)
    1. Percent of positive CA IX metastatic tumor burden compared to total metastatic tumor burden by 18FDG (ratio "Number of positive 89Zr-TLX250 lesions / Number of positive FDG lesions")
    2. If a metastasis biopsy is conducted, assessment of the correlation between the normalized uptake values (SUV) of 89Zr-TLX250 positive lesions and CAIX histological expression will be done by comparing the 89Zr-TLX250 semi-quantitative data with the immunohistochemical results (IHC) of biopsied metastases.
    3. The safety and tolerability of 89Zr-TLX250 will be evaluated by measuring and monitoring vital signs within 2 hours after injection of the radiopharmaceutical. The patient will be informed that in the event of abnormal physical signs, occurring within 24 hours after 89Zr-TLX250 administration, he must report them to the investigator for registration. The reporting period of AEs (related to 89Zr-TLX250) and SAEs cover a period of 30 days after 89Zr-TLX250 administration.
    - The NCI Common Toxicity Criteria, version 5.0 reference will be used.
    - HACA (Human anti-chimeric antibody) will be assessed.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 month
    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 No
    E.6.5Efficacy No
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state12
    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 Decision2021-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-29
    P. End of Trial
    P.End of Trial StatusCompleted
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