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    Summary
    EudraCT Number:2021-001917-35
    Sponsor's Protocol Code Number:NOX66-005
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-08-13
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2021-001917-35
    A.3Full title of the trial
    A Phase 1b/2a Multicenter Study of NOX66 and External Beam Radiotherapy in Patients with Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors
    Fázis 1b/2a multicentrikus klinikai vizsgálat a NOX66 és külső radioterápia együttes alkalmazásával metasztatikus kasztráció-rezisztens prosztata carcinómában és egyéb szolid tumorban szendevő betegek körében
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a Phase 1b/Phase 2a, open-label, multicenter study to determine the safety, tolerability, RP2D, efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) properties of idronoxil when rectally administered as a suppository (NOX66) to patients with any solid tumor (Part 1) and patients with mCRPC, BC and NSCLC (Part 2) who are eligible for low-dose EBRT for at least one symptomatic or minimally symptomatic lesion (for the prevention of symptoms).
    Ez egy 1b/2a fázisú, nyílt, multicentrikus vizsgálat a legalább egy szimptomatikus vagy minimálisan szimptomatikus lézió esetén (a tünetek megelőzése céljából) kis dózisú EBRT-re alkalmas, bármely szolid tumorban szenvedő betegeknek (1. rész), valamint mCRPC-ben, BC-ben és NSCLC-ben (2. rész) rektálisan, végbélkúp formájában adott idronoxil (NOX66) biztonságosságának, tolerálhatóságának, RP2D dózisának, hatásosságának, farmakokinetikai és farmakodinámiás tulajdonságainak meghatározására.
    A.4.1Sponsor's protocol code numberNOX66-005
    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 SponsorNoxopharm Limited
    B.1.3.4CountryAustralia
    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 supportNoxopharm Limited
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNoxopharm Limited
    B.5.2Functional name of contact pointGisela Mautner
    B.5.3 Address:
    B.5.3.1Street AddressSuite 3, Level 4, 828 Pacific Highway
    B.5.3.2Town/ cityGordon
    B.5.3.4CountryAustralia
    B.5.6E-mailGisela.Mautner@noxopharm.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 nameNOX66
    D.3.2Product code NOX66
    D.3.4Pharmaceutical form Suppository
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRectal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIDRONOXIL
    D.3.9.1CAS number 81267-65-4
    D.3.9.2Current sponsor codeNX-101, NV06
    D.3.9.4EV Substance CodeSUB27079
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 No
    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 nameNOX66
    D.3.2Product code NOX66
    D.3.4Pharmaceutical form Suppository
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRectal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIDRONOXIL
    D.3.9.1CAS number 81267-65-4
    D.3.9.2Current sponsor codeNX-101, NV06
    D.3.9.4EV Substance CodeSUB27079
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 No
    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
    Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors
    E.1.1.1Medical condition in easily understood language
    Prostate Cancer and Other Solid Tumors
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1 (Dose Escalation): To determine the MTD(Maximum Tolerated Dose) and RP2D(Recommended Phase 2 Dose) of NOX66 in combination with low-dose EBRT(External Beam Radiotherapy) in patients with any solid tumor
    Part 2 (Dose Expansion):
    -Arm 1: To evaluate the effect of NOX66 on PSA(Prostate-Specific Antigen) response in patients with mCRPC (metastatic Castration-Resistant Prostate Cancer).
    -Arm 2: To evaluate the effect of NOX66 on DCR(Disease Control Rate) in patients with BC(Breast Cancer) and NSCLC(Non-Small-Cell Lung Cancer)
    E.2.2Secondary objectives of the trial
    To characterize the safety and tolerability of NOX66/ To evaluate the safety and tolerability of both doses of EBRT(External Beam Radiotherapy)/ To evaluate the exposure of idronoxil/ To evaluate the preliminary clinical efficacy of NOX66 plus low-dose EBRT(External Beam Radiotherapy) in patients with mCRPC(metastatic Castration-Resistant Prostate Cancer) and other solid tumors/ To Explore the effects of NOX66 on pain and other cancer-related signs and symptoms/ To evaluate the QoL(Quality of Life) using PRO(Patient Reported Outcome) questionnaires
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patient has a minimum life expectancy of 6 months.
    -Patient is 18 years or older at the time of signing the informed consent.
    -Histological or cytological confirmation of prostate cancer, BC, NSCLC and any other solid tumors.
    -Confirmed metastatic disease by imaging (e.g., bone scans, X-rays, ultrasound, computerized tomography [CT], magnetic resonance imaging [MRI]).
    -Documented disease progression (e.g., based on radiographic imaging, PSA or other clinical parameters) following first or later lines of anticancer systemic treatment.
    -Patient is eligible for low-dose EBRT for at least one lesion.
    -Patients with prior RT are eligible, only if there is no potential for field overlap between the prior RT and the planned RT.
    -For patients with BC or NSCLC: Patient must have at least one measurable lesion as per RECIST v1.1 (in Part 2 only).
    -Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
    -Adequate bone marrow function defined as:
    • Absolute neutrophil count ≥ 1.5 × 109/L.
    • Platelet count ≥ 100 × 109/L.
    • Hemoglobin ≥ 9.0 g/dL (with or without transfusion).
    -Adequate renal function defined as:
    • Creatinine clearance as measured by the Cockcroft-Gault equation > 30 mL/min.
    -Adequate liver function defined as:
    • Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN; patients with confirmed Gilbert’s syndrome may be included in the study).
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastasis). Elevated alkaline phosphatase is not exclusionary if due to the presence of bone metastasis and liver function is otherwise considered adequate in the Investigator’s judgement.
    -Baseline testosterone levels ≤ 14.4 ng/dL and ongoing medical castration must be maintained throughout the duration of the study.
    -Patient has evidence of symptomatic and/or progressive disease. Progressive disease is defined as any one of the following:
    • Radiographic disease progression in soft tissue (nodule or visceral metastasis) and/or bone with or without PSA progression. Objective evidence of increase in radiographic lesions or the appearance of 2 or more new lesions.
    • Prostate-specific antigen progression: At least 3 consecutive rising PSA levels (≥ 2 to 5 ng/mL) separated by at least 1 week, with castrate levels of testosterone.
    -Known hormone receptor status (estrogen receptors/progesterone receptors or estrogen receptors alone). Breast cancer patients are allowed to be on background hormonal treatment.
    -Patient must have had a vasectomy or must agree to use a highly effective contraception as detailed in Section 10.5 of this protocol during the treatment period and for at least 3 months after the last dose of study drug and refrain from donating sperm during this period.
    -A female patient is eligible to participate if she is not pregnant (see Section 10.5), not breastfeeding, and at least one of the following conditions applies:
    • Not a woman of childbearing potential (WOCBP) as defined in Section 10.5.
    OR
    • A WOCBP who agrees to follow the contraceptive guidance in Section 10.5 and not to donate ova during the treatment period and for at least 3 months after the last dose of study drug.
    E.4Principal exclusion criteria
    -Patient has tumor involvement of the central nervous system.
    -Impaired cardiac functioning or clinically significant cardiac disease, including the following:
    • Acute myocardial infarction or unstable angina pectoris ≤ 6 months prior to starting study drug.
    • Corrected QT interval using Fridericia’s formula > 470 msec on screening ECG.
    • Uncontrolled clinically significant cardiac arrhythmia.
    -Uncontrolled hypertension despite two concomitant antihypertensive therapies, defined as supine systolic blood pressure ≥ 150 mmHg or diastolic blood pressure > 100 mmHg based on a mean of three measurements at approximately 2-minute intervals.
    -Patients who have had a colectomy (total or left hemicolectomy) with re-anastomosis.
    -Patients for whom administration of the suppositories are likely to cause pain or difficulties in absorption.
    -Patients with fecal impaction or uncontrolled irritable bowel disease.
    -Patients with inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis) will be excluded, even if the condition is well controlled.
    -Active or chronic infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C. Screening of patients with serology testing for these viruses is not required. However, patients who have a past history of viral hepatitis or in whom there is a current suspicion of viral hepatitis will have serology testing for hepatitis B and hepatitis C performed to determine whether there is any current evidence of ongoing infection with these viruses. Patients considered to be at risk for HIV infection should have HIV testing performed. If the test result is negative, the patient will be allowed to participate in the study.
    -Any other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding that, in the Investigator’s opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
    -Patients with oligometastatic disease (fewer than 5 metastatic lesions) amenable to standard therapy will be excluded.
    -Major surgery within 4 weeks or minor surgery or biopsy within 1 week of the first dose administration.
    -Patients who have had RT to the region of the rectum or will require RT to the region of the rectum during the trial.
    -Uncontrolled active infection requiring intravenous antibiotic, antiviral or anti-fungal medications within 14 days before the first dose administration. Infections (e.g., urinary tract infection) controlled on concurrent anti-microbial agents and anti-microbial prophylaxis per institutional guidelines are acceptable.
    -Receiving or having received anticancer treatment within the following period prior to the first dose administration:
    • Cytotoxic treatment: 3 weeks.
    • Non-cytotoxic drugs, including small molecule investigational products: 3 weeks or 5 terminal half-lives from plasma (whichever is the longest).
    • Biological products including investigational immune-oncology agents: 4 weeks.
    • Radiation with a limited field for palliation: 4 weeks.
    • Radiation to > 30% of the bone marrow: 4 weeks.
    • Lung radiation: 60 days.
    -Patient has received corticosteroids at a dose of > 10 mg prednisone/day or equivalent for any reason within 4 weeks prior to receiving the first dose administration.
    -History of hypersensitivity to active or inactive excipients of study drug or drugs with a similar chemical structure or class to the study drug.
    -Patient is not willing to use suppositories.
    -Judgement by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
    -Patient has a positive reverse transcription polymerase chain reaction (RT-PCR) test for SARS-CoV-2 prior to Screening or enrollment, or has clinical signs and symptoms consistent with SARS-CoV-2 infection; e.g., fever, dry cough, dyspnea, sore throat, fatigue or positive SARS-CoV-2 test result within 2 weeks prior to Screening. Patients who had symptomatic COVID-19 disease less than 1 month prior to Screening will be excluded. If a patient has had a severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated) within 4 weeks of Screening, or have any sequelae of infection or ongoing infection, the patient will also be excluded. If the patient has had recent (within previous
    14 days) exposure to someone who has COVID-19 symptoms, been in contact with someone who has tested positive for COVID-19 or visited a COVID-19 treatment facility, the patient may be re-evaluated for participation in the study after undergoing an isolation period of at least 10 days and having a negative SARS-CoV-2 RT-PCR test prior to enrollment.
    E.5 End points
    E.5.1Primary end point(s)
    -Part 1 (Dose Escalation): The primary objective for Part 1 will be determined based on the count of DLTs.
    • MTD is defined as the dose level at which no more than 1 patient out of 6 experiences a DLT at the end of Cycle 1.
    • RP2D is the highest dose administered at which no more than 1 patient out of 6 experiences a DLT at the end of Cycle 1 and the dosage form, including the dosing frequency, is acceptable to patients.
    -Part 2 (Dose Expansion):
    • PSA response is defined as the proportion of patients with a reduction in PSA in plasma (ng/mL) of ≥ 30% from baseline at the end of Cycles 3 and 6.
    • DCR is measured by the percentage of patients with a best overall confirmed response of CR or PR and SD.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout trial treatment/follow-up period
    E.5.2Secondary end point(s)
    -Safety and tolerability of NOX66 as determined by AEs, TEAEs, clinical laboratory evaluations, vital signs, 12-lead ECG and physical examinations.
    -Safety and tolerability of both doses of EBRT as determined by AEs, TEAEs, clinical laboratory evaluations, vital signs, 12-lead ECG and physical examinations.
    -Concentration of idronoxil and selected metabolites in plasma and derived PK parameters, including but not limited to: Cmax, Tmax, AUC(0-t), AUC(0-6), AUC(0-12), AUC(0-inf), Cmin and t½, as data permit.
    -Preliminary clinical efficacy as determined by:
    • Change from baseline in PSA (mCRPC only) at any time point.
    • Overall response rate assessed by RECIST v1.1 criteria (all tumor types) and PCWG-3 criteria (mCRPC).
    • Duration of response (for patients with measurable disease).
    • Change from baseline ECOG scores.
    • Change from baseline in tumor size and number.
    • PFS and OS.
    -Effects on pain and other cancer-related signs and symptoms as determined by:
    • Change from baseline in pain scores based on the BPI-SF questionnaire.
    • SREs and SSEs.
    • Change of dose and frequency of morphine administration and analgesic use.
    -QoL as assessed by:
    • Change from baseline in PEQ.
    • Change from baseline in EORTC-QLQ-C30.
    • Change from baseline in FACT-P (mCRPC only).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout trial treatment/follow-up period
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) 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
    Safety, tolerability, RP2D, efficacy, pharmacokinetics and pharmacodynamic of NOX66
    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 Yes
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    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
    United States
    France
    Hungary
    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
    For the entire study, study completion is defined as the last visit of the last patient for any protocol related activity (last patient, last visit), including telephone contact. For individual patients, study completion is defined as the time of the patient’s last data collection.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years3
    E.8.9.2In all countries concerned by the trial months0
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 100
    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)
    The study will finish when the last patient enrolled in Part 2 completed 6 months of treatment; all patients receiving study drug at that time will be switched to the NOX66 compassionate access program. Those patients on the compassionate access program will continue to receive NOX66 treatment until disease progression or unacceptable toxicity. These patients will be followed until death, or the patient is lost to follow-up.
    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 Decision2021-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-06-07
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