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    Summary
    EudraCT Number:2015-001105-13
    Sponsor's Protocol Code Number:STREAM
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-06
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-001105-13
    A.3Full title of the trial
    Regorafenib monotherapy as second-line treatment of patients with RAS-mutant advanced colorectal cancer: a multicentre, single-arm, two-stage, phase 2 study.
    Regorafenib monotherapy as second-line treatment of patients with RAS-mutant advanced colorectal cancer: a multicentre, single-arm, two-stage, phase 2 study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Regorafenib monotherapy as second-line treatment of patients with RAS-mutant advanced colorectal cancer: a multicentre, single-arm, two-stage, phase 2 study.
    Regorafenib in monoterapia come trattamento di seconda linea di pazienti affetti da carcinoma colorettale con mutazioni di RAS: studio mutlicentrico di fase 2, a singolo braccio, a due stadi.
    A.3.2Name or abbreviated title of the trial where available
    Second-line Treatment with REgorafenib in Advanced RAS-Mutant colorectal cancer
    Second-line Treatment with REgorafenib in Advanced RAS-Mutant colorectal cancer
    A.4.1Sponsor's protocol code numberSTREAM
    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 SponsorISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
    B.1.3.4CountryItaly
    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 supportBayer
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Tumori di Napoli
    B.5.2Functional name of contact pointUnità sperimentazioni cliniche
    B.5.3 Address:
    B.5.3.1Street AddressVia Mariano Semmola snc
    B.5.3.2Town/ cityNapoli
    B.5.3.3Post code80131
    B.5.3.4CountryItaly
    B.5.4Telephone number0815903571
    B.5.5Fax number0817702938
    B.5.6E-mailusc-segreteria@istitutotumori.na.it
    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 Yes
    D.2.1.1.1Trade name STIVARGA - 40 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - FLACONE (HDPE) - 28 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER PHARMA AG
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameregorafenib
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    patients with RAS-mutant advanced colorectal cancer
    pazienti affetti da carcinoma colorettale con mutazioni di RAS
    E.1.1.1Medical condition in easily understood language
    patients with RAS-mutant advanced colorectal cancer
    pazienti affetti da carcinoma colorettale con mutazioni di RAS
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10038029
    E.1.2Term Rectal adenocarcinoma stage IV
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10001172
    E.1.2Term Adenocarcinoma of colon stage IV
    E.1.2System Organ Class 100000004864
    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 if regorafenib is active enough, in terms of 6-month progression-free rate, to warrant further comparative studies in patients with RAS-mutant advanced colorectal cancer who have progressed after first-line oxaliplatin-based chemotherapy plus bevacizumab.
    Valutare se regorafenib sia sufficientemente attivo, in termini di tasso di pazienti liberi da progressione a 6 mesi, da motivare studi di tipo comparativo di fase 3 in pazienti affetti da carcinoma colorettale avanzato con mutazioni di RAS, che siano in progressione dopo un trattamento di prima linea con chemioterapia contenente oxaliplatino in combinazione con bevacizumab.
    E.2.2Secondary objectives of the trial
    To describe:
    - toxicity
    - objective response rate
    - progression free-survival
    - overall survival.

    To explore the prognostic and predictive value of:
    - circulating endothelial (CEC) and progenitor (CEP) cells (at baseline and during treatment)
    - circulating angiogenic factors (i.e. angiopoietin, sTIE, Ang-2, VEGF isoforms, PDGF, PlGF, sVEGF-R-1 and -2 isoforms)
    - circulating cytokines profiling
    - circulating miRNA profiling
    - circulating free DNA (cfDNA) mutations
    - VEGF, VEGFR, CYP3A4 and UTG1A9 polymorphisms
    - early assessment of metabolic response with PET-CT scan.
    Descrivere:
    - tossicità;
    - risposte obiettive;
    - sopravvivenza libera da progressione;
    - sopravvivenza globale.

    Esplorare il valore prognostico e predittivo di:
    - cellule endoteliali circolanti (CEC) e progenitrici (CEP) (al basale e durante il trattamento)
    - fattori angiogentici circolanti (angiopoietina, sTIE, Ang-2, isoforme di VEGF, PDGF, PlGF, isoforme sVEGF-R-1 e -2)
    - profilo di citochine circolanti
    - profilo di miRNA circolanti
    - mutazioni del DNA libero circolante (circulating free DNA, cfDNA)
    - polimorfismi di VEGF, VEGFR, CYP3A4 e UTG1A9
    - valutazioni precoce della risposta metabolica misurata con PET-TC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria

    1. Histologically confirmed diagnosis of colorectal adenocarcinoma
    2. Any RAS mutation that prevent treatment with anti-EGFR antibodies
    3. Stage IV
    4. Measurable disease according to RECIST v. 1.1
    5. Disease progression during or following a treatment with fluoropyrimidine, oxaliplatin and bevacizumab, and a treatment with irinotecan is not considered immediately mandatory by the Investigator
    6. Age = 18 years
    7. ECOG Performance Status 0-1
    8. Neutrophils > 1,5 x 109/L, platelets > 100 x 109/L, and hemoglobin > 9 g/dL without transfusion or granulocyte-colony stimulating factor (G-CSF) and other hematopietic growth factors.
    9. Bilirubin level < 1.5 x ULN
    10. Glomerular filtration rate > 30 mL/min/1.73 m2 according to the Modified Diet in Renal Disease abbreviated formula
    11. AST (SGOT) and ALT (SGPT) = 3.0 x ULN (= 5 x ULN if liver metastasis are present)
    12. Alkaline phosphatase = 2.5 x ULN (= 5 x ULN if liver metastasis are present)
    13. Serum creatinine < 1.5 x ULN
    14. Amilase and lipase = 1.5 x ULN
    15. INR and aPTT = 1.5 x ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no underlying abnormality in coagulation parameters exists per medical history.
    16. Understand, be willing to give consent, and sign the written informed consent form (ICF) prior to undergoing any study-specific procedure.
    17. If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment.
    18. If female and of childbearing potential, or if male, agree to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method) based on the judgment of the investigator or a designated associate from the date on which the ICF is signed until 8 weeks after the last dose of study drug.
    19. Life expectancy of greater than 3 months
    1. Diagnosi istologica di adenocarcinoma del colon-retto
    2. Qualsiasi mutazione di RAS che controindichi il trattamento con anticorpi anti-EGFR
    3. Stadio IV
    4. Malattia misurabile secondo RECIST v. 1.1
    5. Progressione di malattia durante o successivamente a un trattamento con fluoropirimidine, oxaliplatino e bevacizumab, per cui lo sperimentatore non ritenga immediatamente obbligatorio un trattamento a base di irinotecan
    6. Età = 18 anni
    7. Performance Status ECOG 0-1
    8. Neutrofili > 1,5 x 109/L, piastrine > 100 x 109/L, e emoglobina > 9 g/dL, senza ricorso a trasfusioni o G-CSF o altri fattori di crescita ematopoietici
    9. Bilirubina < 1.5 x limite superiore di normalità (LSN)
    10. Tasso di filtrazione glomerulare > 30 mL/min/1.73 m2 secondo la formula Modified Diet in Renal Disease abbreviata
    11. AST (SGOT) and ALT (SGPT) = 3.0 x LSN (= 5 x LSN se presenti metastasi epatiche)
    12. Fosfatasi alcalina = 2.5 x LSN (= 5 x LSN se presenti metastasi epatiche)
    13. Creatininemia < 1.5 x LSN
    14. Amilasi e lipasi = 1.5 x LSN
    15. INR e aPTT = 1.5 x LSN. I pazienti in terapia con agenti quail warfarin o eparina possono partecipare allo studio se non coesistono anomalie dei parametri della coagulazione
    16. Consenso informato scritto prima di qualunque procedura studio-specifica
    17. Se donna potenzialmente fertile, test di gravidanza negativo nei 7 giorni precedent l’inizio del trattamento
    18. Se donna potenzialmente fertile, o se uomo, accordo sull’uso di una contraccezione efficace (astinenza, dispositivo intrauterino, contraccettivi orali o metodi di doppia barriera) dalla data della firma del consenso, fino a 8 settimane dopo l’ultima dose di regorafenib
    19. Aspettativa di vita > 3 mesi
    E.4Principal exclusion criteria

    1. Previous treatment with regorafenib or irinotecan
    2. Are taking strong cytochrome P (CYP) CYP3A4 inhibitors (eg, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifampin, St. John’s Wort)
    3. Have had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment
    4. Have congestive heart failure classified as New York Heart Association Class 2 or higher
    5. Have had unstable angina (angina symptoms at rest) or new-onset angina < 3 months prior to screening.
    6. Have had a myocardial infarction < 6 months prior to initiation of study treatment.
    7. Have cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin.
    8. Have had arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months prior to the initiation of study treatment
    9. Symptomatic brain metastases or meningeal tumors
    10. Patients with evidence or history of bleeding diathesis
    11. Uncontrolled hypertension (systolic blood pressure [SBP] >140 mmHg or diastolic blood pressure [DBP] > 90 mmHg)
    12. Have interstitial lung disease with ongoing signs and symptoms at the time informed consent is obtained
    13. Have persistent proteinuria > 3.5 g/24 hours measured by urine protein creatinine ratio from a random urine sample (> Grade 3, NCI-CTCAE v 4.0).
    14. Have unresolved toxicity higher than National Cancer Institute-Common Terminology for Adverse Events version 4.0 (NCI-CTCAE v 4.0) Grade 1 attributed to any prior therapy/procedure, excluding alopecia and/or oxaliplatin-induced neurotoxicity = Grade 2 and hemoglobin = 9 g/dL as per inclusion criteria
    15. Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease
    16. Pregnant or lactating women
    17. Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
    18. Any unstable systemic disease (including active infections, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of regorafenib or render the patient at high risk for treatment complications
    19. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
    20. Have any other serious or unstable illness, or medical, psychological, or social condition, that could jeopardize the safety of the subject and/or his/her compliance with study procedures, or may interfere with the subject’s participation in the study or evaluation of the study results.
    21. Have a known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs.
    22. Have a close affiliation with the investigational site (eg, be a close relative of the investigator) or be a dependent person (eg, be an employee or student working at the investigational site).

    1. Precedente trattamento con regorafenib o irinotecan
    2. In trattamento con inibitori forti del citocromo P (CYP) 3A4 (es. claritromicina, indinavir, itraconazolo, ketoconazolo, nefazodone, nelfinavir, posaconazolo, ritonavir, saquinavir, telitromicina, voriconazolo) o induttori forti del CYP3A4 (es. carbamazepina, fenobarbital, fenitoina, rifampin, erba di S.Giovanni)
    3. Porcedura di chirurgia maggiore, biopsia chirurgica o lesione traumatica significativa nei 28 giorni precedenti l’inizio del trattamento
    4. Scompenso cardiaco congestizio classe NYHA > 2
    5. Angina instabile (sintomi a riposo) o angina di nuova insorgenza nei 3 mesi precedenti lo screening
    6. Infarto del miocardio < 6 mesi prima dell’inizio del trattamento
    7. Disturbi del ritmo cardiaco che richiedano una terapia con anti-aritmici, ad eccezione di beta-boloccanti e digossina.
    8. Eventi trombotici o embolici, arteriosi o venosi, come accidenti cerebro-vascolari (inclusi gli attacchi ischemici transitori), trombosi venosa profonda o embolia polmonare, nei sei mesi precedenti l’inizio del trattamento
    9. Metastasi cerebrali sintomatiche o tumori meningei
    10. Pazienti con evidenza o storia di diatesi emorragica
    11. Ipertensione non controllata (pressione sistolica >140 mmHg o pressione diastolica > 90 mmHg)
    12. Malattia interstiziale polmonare con segni e sintomi in corso al momento della firma del consenso
    13. Proteinuria persistente > 3.5 g/24 ore, misurata con il rapporto proteine nelle urine/creatinina, su un campione di urina casuale (=Grade 3, CTCAE v 4.0).
    14. Persistenza di una tossicità > grado 1 secondo i Common Terminology for Adverse Events versione 4.0 (CTCAE v 4.0) attribuita a una precedente terapia o procedura, ad eccezione di alopecia, neurotossicità da oxaliplatino di grado = 2 e emoglobina = 9 g/dL coerentemente con i criteri di inclusione
    15. Pazienti che non possono assumere farmaci per via orale, che richiedono l’alimentazione parenterale, che hanno subito procedure chirurgiche che possono influenzare l’assorbimento intestinale, o che sono affetti da ulcera peptica attiva.
    16. Gravidanza o allattamento
    17. Qualunque altro tumore maligno nei 5 anni precedenti (ad eccezione di carcinoma in situ della cervice o tumori cutanei non-melanoma, adeguatamente trattati)
    18. Qualunque malattia sistemica instabile (incluso infezioni attive e qualunque significativa malattia metabolica, epatica o renale), disfunzioni metabolica, reperto clinico o di laboratorio che controindichi l’uso di regorafenib o aumenti il rischio di complicanze del trattamento
    19. Maschi o femmine potenzialmente fertili sessualmente attivi che rifiutino di adottare efficaci metodi contraccettivi durante lo studio
    20. Qualunque altra malattia grave o instabile, o condizione medica, psicologica o sociale, che possa compromettere la sicurezza del soggetto e/o la sua compliance alle procedure dello studio, o che possa interferire con la partecipazione del soggetto allo studio e con la valutazione dei risultati dello studio
    21. Ipersensibilità nota al farmaco in studio o ad un altro farmaco della stessa classe, o agli eccipienti presenti nella formulazione del farmaco in studio
    22. Pazienti che abbiano un legame stretto con il centro di sperimentazione (es. un parente stretto dello sperimentatore) o ne siano dipendenti (es. un impiegato o uno studente frequentatore del centro).

    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the rate of patients alive and not progressed at 6 months.
    L’endpoint primario è il tasso di pazienti vivi e non in progressione a 6 mesi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months from registration
    6 mesi dalla registrazione
    E.5.2Secondary end point(s)
    - toxicity
    - objective response rate
    - progression free-survival
    - overall survival
    - tossicità;
    - risposte obiettive;
    - sopravvivenza libera da progressione;
    - sopravvivenza globale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - toxicity weekly;
    - objective response rate every six weeks
    - progression free-survival every six weeks
    - overall survival death
    - tossicità settimanale;
    - risposte obiettive ogni 6 settimane;
    - sopravvivenza libera da progressione ogni 6 settimane;
    - sopravvivenza globale al tempo del decesso;
    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 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.8.2.4Number of treatment arms in the trial1
    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 concerned9
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA9
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state46
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 46
    F.4.2.2In the whole clinical trial 46
    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
    nessuno
    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 Decision2015-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-20
    P. End of Trial
    P.End of Trial StatusOngoing
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