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Fase 2 undersøgelse af Poziotinib hos patienter med NSCLC, der har EGFR eller HER2 Exon 20 Insertion Mutation

11. juni 2026 opdateret af: Spectrum Pharmaceuticals, Inc

Et fase 2-studie af Poziotinib hos patienter med ikke-småcellet lungekræft (NSCLC), lokalt avanceret eller metastatisk, med EGFR eller HER2 Exon 20-indsættelsesmutation (ZENITH20)

Dette er et fase 2, åbent, multicenter-studie for at evaluere effektiviteten og sikkerheden/tolerabiliteten af ​​poziotinib i syv patientkohorter for op til 603 tidligere behandlede og behandlingsnaive NSCLC-patienter. Kohorter 3 og 4 blev tilføjet med ændringsforslag 1, og tre yderligere kohorter blev tilføjet med ændringsforslag 2 (kohorter 5, 6 og 7).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Screeningsperioden (dag -30 til dag -1) varer op til ca. 30 dage før cyklus 1, dag 1. Patienter skal opfylde alle inklusions-/eksklusionskriterier for at deltage i undersøgelsen. Kvalificerede patienter vil give skriftligt informeret samtykke, før de gennemgår undersøgelsesprocedurer.

Hver behandlingscyklus varer 28 kalenderdage. Der vil være syv patientkohorter, og kvalificerede patienter vil blive indskrevet i hver kohorte parallelt baseret på EGFR eller HER2 exon 20 mutationsstatus og tidligere behandlingsstatus:

  • Kohorte 1: Tidligere behandlede patienter med EGFR exon 20 insertionsmutationspositiv NSCLC (lukket for tilmelding)
  • Kohorte 2: Tidligere behandlede patienter med HER2 exon 20 insertionsmutationspositiv NSCLC (lukket for tilmelding)
  • Kohorte 3: Behandlingsnaive patienter med EGFR exon 20 insertionsmutationspositiv NSCLC (fuldt tilmeldt)
  • Kohorte 4: Behandlingsnaive patienter med HER2 exon 20 insertionsmutationspositiv NSCLC
  • Kohorte 5: Patienter, der opfylder kriterierne for optagelse i kohorte 1 til 4, men indskrivningen i den respektive kohorte er lukket
  • Kohorte 6: Patienter med erhvervet EGFR-mutation, som udviklede sig, mens de var i behandling med førstelinjes osimertinib
  • Kohorte 7: Patienter med EGFR- eller HER2-aktiverende mutationer

Toksiciteten vil blive vurderet ud fra graden af ​​bivirkningerne ved brug af CTCAE version 4.03.

På dag 1 i hver 28-dages cyklus skal patientens absolutte neutrofiltal (ANC) være ≥1,5×10^9/L, og trombocyttallet skal være ≥100×10^9/L før administration af poziotinib. Alle patienter vil blive behandlet indtil sygdomsprogression (undtagen første progression i kohorte 5), død, utålelige bivirkninger (AE'er) eller andre protokolspecificerede årsager til patientens tilbagetrækning.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

648

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Brussels, Belgien
        • Saint Luc University Hospital
      • Leuven, Belgien
        • University Hospitals Leuven
      • Mons, Belgien
        • Ambroise Pare University Hospital Center
      • Roeselare, Belgien
        • General Hospital Delta
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer - Vancouver
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Regional Cancer Program
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85054
        • Mayo Clinic Hospital
    • California
      • Arcadia, California, Forenede Stater, 91007
        • Oncology Physician's Network Inc./OPN Healthcare
      • Duarte, California, Forenede Stater, 91010
        • City of Hope
      • La Jolla, California, Forenede Stater, 92093
        • UCSD -Moores Cancer Center
      • Long Beach, California, Forenede Stater, 90813
        • Pacific Shores Medical Group
      • Los Angeles, California, Forenede Stater, 90017
        • Los Angeles Hematology Oncology Medical Group
      • Los Angeles, California, Forenede Stater, 90033
        • USC/Norris Comprehensive Cancer Center
      • Sacramento, California, Forenede Stater, 95817
        • UC Davis Comprehensive Cancer Center
      • San Francisco, California, Forenede Stater, 94115
        • UCSF Helen Diller Comprehensive Cancer Center at Mt Zion
      • Santa Monica, California, Forenede Stater, 90404
        • UCLA Hematology/Oncology
      • Torrance, California, Forenede Stater, 90502
        • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
      • Vallejo, California, Forenede Stater, 94589
        • Kaiser Permanente Medical Center
    • Colorado
      • Boulder, Colorado, Forenede Stater, 80303
        • Rocky Mountain Cancer Center
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06510
        • Yale University, Yale Cancer Center Smilow Cancer Hospital at Yale
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20007
        • Georgetown University Medical Center
    • Florida
      • Orlando, Florida, Forenede Stater, 32804
        • Florida Hospital
      • Tampa, Florida, Forenede Stater, 33612
        • H. Lee Moffitt Cancer Center & Research Institute
      • Winter Haven, Florida, Forenede Stater, 33881
        • The Bond & Steele Clinic, P.A. dba Bond Clinic, P.A.
    • Georgia
      • Athens, Georgia, Forenede Stater, 30607
        • University Cancer & Blood Center, LLC
      • Newnan, Georgia, Forenede Stater, 30265
        • CTCA - Southeastern Regional Medical Center
    • Illinois
      • Zion, Illinois, Forenede Stater, 60099
        • CTCA - Midwestern Regional Medical Center
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Karmanos Cancer Institute
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55404
        • Minnesota Oncology Hematology, P.A.
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic
    • Mississippi
      • Hattiesburg, Mississippi, Forenede Stater, 39401
        • Hattiesburg Clinic Hematology/Oncology
    • New York
      • Buffalo, New York, Forenede Stater, 14263
        • Roswell Park Cancer Institute
      • New York, New York, Forenede Stater, 10065
        • Weill Cornell Medical College
      • New York, New York, Forenede Stater, 10016
        • NYU Langone Medical Center
      • Port Jefferson Station, New York, Forenede Stater, 11776
        • North Shore Hematology Oncology Associates P.C. DBA NY Cancer and Blood Specialists
      • The Bronx, New York, Forenede Stater, 10461
        • Montefiore Einstein Medical Center for Cancer Care
      • The Bronx, New York, Forenede Stater, 10469
        • North Shore Hematology Oncology Associates DBA New York Cancer and Blood Specialists
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic
      • Columbus, Ohio, Forenede Stater, 43210
        • The Ohio State University
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74146
        • Oklahoma Cancer Specialists and Research Institute, LLC
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19124
        • CTCA - Eastern Regional Medical Center
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38120
        • Baptist Cancer Center
    • Texas
      • Austin, Texas, Forenede Stater, 78745
        • Texas Oncology- Austin
      • Houston, Texas, Forenede Stater, 77030
        • Md Anderson Cancer Center
    • Virginia
      • Fairfax, Virginia, Forenede Stater, 22031
        • Virginia Cancer Specialists, PC
    • Washington
      • Seattle, Washington, Forenede Stater, 98109
        • Seattle Cancer Care Alliance
  • Frankrig
      • Toulouse, Frankrig
        • Hopital Larrey, CHU Toulouse, Unité d'Oncologie des Voies Respiratoires
      • Villejuif, Frankrig
        • Gustave Roussy Oncology Institute, Department of Medical Oncology
  • Holland
      • Rotterdam, Holland
        • Erasmus Medical Center
  • Israel
      • Beersheba, Israel
        • Soroka Medical Center
      • Haifa, Israel
        • Rambam Healthcare Campus
      • Jerusalem, Israel
        • Hadassah Medical Center
      • Petah Tikva, Israel
        • Rabin Medical Center
  • Italien
      • Milan, Italien
        • National Cancer Institute, IRCCS, Department of Medical Oncology
      • Ravenna, Italien
        • Santa Maria delle Croci Hospital
      • Rome, Italien
        • National Cancer Institute Regina Elena, IRCCS, Operative Unit of Medical Oncology A 1
  • Spanien
      • Barcelona, Spanien
        • University Hospital Germans Trias i Pujol, Department of Medical Oncology
      • Madrid, Spanien
        • University Hospital 12 de Octubre

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Nøgleinklusionskriterier:

  • Patienten skal være villig og i stand til at give skriftligt informeret samtykke, overholde doserings- og besøgsplaner og opfylde alle undersøgelseskrav
  • Patienten har histologisk eller cytologisk bekræftet lokalt fremskreden eller metastatisk ikke-småcellet lungekræft (NSCLC), der ikke er modtagelig for behandling med helbredende hensigter

  • Tidligere behandlingsstatus:

    • Kohorte 1 og 2: Patienten har haft mindst én tidligere systemisk behandling for lokalt fremskreden eller metastatisk NSCLC
    • Kohorte 3 og 4: Patienten er behandlingsnaiv for lokalt fremskreden eller metastatisk NSCLC og kvalificeret til at modtage førstelinjebehandling med poziotinib som bestemt af investigator. Adjuverende/neo-adjuverende terapier (kemoterapi, strålebehandling eller forsøgsmidler) er tilladte, så længe de afsluttes mindst 15 dage før studiestart.
    • Kohorte 5: Patienter, der opfylder kriterierne for optagelse i kohorte 1 til 4, men indskrivningen i den respektive kohorte er lukket
    • Kohorte 6: Patienter med EGFR-mutationspositiv NSCLC, som udviklede sig under behandling med førstelinjes osimertinib
    • Kohorte 7: Patienten har haft mindst én tidligere systemisk behandling for lokalt fremskreden eller metastatisk NSCLC

  • Specifikke mutationer:

    • Kohorte 1 og 3: Dokumenteret EGFR exon 20 indsættelsesmutation
    • Kohorte 2 og 4: Dokumenteret HER2 exon 20 insertionsmutation
    • Kohorte 5: Dokumenterede EGFR eller HER2 exon 20 indsættelsesmutationer
    • Kohorte 6: Dokumenteret erhvervet EGFR-mutation (testet efter osmertinib-progression)
    • Kohorte 7: Dokumenterede EGFR- eller HER2-aktiverende mutationer
  • Patienten har tilstrækkelig organfunktion ved baseline

Nøgleekskluderingskriterier:

  • Patienten har tidligere haft behandling med poziotinib eller en hvilken som helst anden EGFR eller HER2 exon 20 insertionsmutationsselektiv tyrosinkinasehæmmer (TKI) før deltagelse i undersøgelsen. De aktuelt godkendte TKI'er (dvs. erlotinib, gefitinib, afatinib, osimertinib) anses ikke for at være exon 20 insertionsselektive og er tilladte (kohorte 1 og 2).
  • Patienten modtager samtidig kemoterapi, biologiske lægemidler, immunterapi til kræftbehandling; systemisk anti-cancerbehandling eller forsøgsbehandling bør ikke anvendes inden for 2 uger eller 5 halveringstider, alt efter hvad der er længst; lokal strålebehandling mod knoglesmerter kan tillades
  • Patienten har haft andre maligniteter inden for de seneste 3 år, bortset fra stabil ikke-melanom hudkræft, fuldt behandlet og stabil, tidligt stadie af prostatacancer eller carcinom in situ i livmoderhalsen eller brystet uden behov for behandling
  • Patienten er gravid eller ammer

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cohort 1: Poziotinib 16 mg
Participants previously treated for epidermal growth factor receptor (EGFR) exon 20 insertion mutation-positive non-small cell lung cancer (NSCLC) received poziotinib, 16 milligrams (mg), orally, once daily (QD) in each 28-day cycle until disease progression, death, intolerable adverse events (AEs), or for up to a maximum of 35 months, whichever occurs first.
Medicin: Poziotinib
Lægemidlet poziotinib er et hydrochloridsalt af poziotinib og er formuleret som en tablet til oral administration.
Eksperimentel: Cohort 2: Poziotinib 16 mg
Participants previously treated for human epidermal growth factor receptor 2 (HER2) exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 32 months, whichever occurs first.
Medicin: Poziotinib
Lægemidlet poziotinib er et hydrochloridsalt af poziotinib og er formuleret som en tablet til oral administration.
Eksperimentel: Cohort 3: Poziotinib 16 mg
Treatment naïve participants with EGFR exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 24 months, whichever occurs first.
Medicin: Poziotinib
Lægemidlet poziotinib er et hydrochloridsalt af poziotinib og er formuleret som en tablet til oral administration.
Eksperimentel: Cohort 4: Poziotinib 8 mg
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 8 mg, orally, twice daily (BID) in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
Medicin: Poziotinib
Lægemidlet poziotinib er et hydrochloridsalt af poziotinib og er formuleret som en tablet til oral administration.
Eksperimentel: Cohort 4: Poziotinib 16 mg
Treatment naïve participants with HER2 exon 20 insertion mutation-positive NSCLC received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 27 months, whichever occurs first.
Medicin: Poziotinib
Lægemidlet poziotinib er et hydrochloridsalt af poziotinib og er formuleret som en tablet til oral administration.
Eksperimentel: Cohort 5: Poziotinib 6 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 6 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 23 months, whichever occurs first.
Medicin: Poziotinib
Lægemidlet poziotinib er et hydrochloridsalt af poziotinib og er formuleret som en tablet til oral administration.
Eksperimentel: Cohort 5: Poziotinib 8mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 25 months, whichever occurs first.
Medicin: Poziotinib
Lægemidlet poziotinib er et hydrochloridsalt af poziotinib og er formuleret som en tablet til oral administration.
Eksperimentel: Cohort 5: Poziotinib 10 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 10 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 15 months, whichever occurs first.
Medicin: Poziotinib
Lægemidlet poziotinib er et hydrochloridsalt af poziotinib og er formuleret som en tablet til oral administration.
Eksperimentel: Cohort 5: Poziotinib 12 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 12 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 26 months, whichever occurs first.
Medicin: Poziotinib
Lægemidlet poziotinib er et hydrochloridsalt af poziotinib og er formuleret som en tablet til oral administration.
Eksperimentel: Cohort 5: Poziotinib 16 mg
Participants who met the criteria for enrollment in Cohort 1 to Cohort 4, but the enrollment in the respective cohort had been closed were enrolled in this cohort and received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression (except first progression), death, intolerable AEs, or for up to a maximum of 18 months, whichever occurs first.
Medicin: Poziotinib
Lægemidlet poziotinib er et hydrochloridsalt af poziotinib og er formuleret som en tablet til oral administration.
Eksperimentel: Cohort 6: Poziotinib 8 mg
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 29 months, whichever occurs first.
Medicin: Poziotinib
Lægemidlet poziotinib er et hydrochloridsalt af poziotinib og er formuleret som en tablet til oral administration.
Eksperimentel: Cohort 6: Poziotinib 16 mg
Participants with acquired EGFR mutation who progressed while on treatment with first-line osimertinib received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 7 months, whichever occurs first.
Medicin: Poziotinib
Lægemidlet poziotinib er et hydrochloridsalt af poziotinib og er formuleret som en tablet til oral administration.
Eksperimentel: Cohort 7: Poziotinib 8 mg
Participants with EGFR or HER2 activating mutations received poziotinib, 8 mg, orally, BID in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 20 months, whichever occurs first.
Medicin: Poziotinib
Lægemidlet poziotinib er et hydrochloridsalt af poziotinib og er formuleret som en tablet til oral administration.
Eksperimentel: Cohort 7: Poziotinib 16 mg
Participants with EGFR or HER2 activating mutations received poziotinib, 16 mg, orally, QD in each 28-day cycle until disease progression, death, intolerable AEs, or for up to a maximum of 4 months, whichever occurs first.
Medicin: Poziotinib
Lægemidlet poziotinib er et hydrochloridsalt af poziotinib og er formuleret som en tablet til oral administration.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate (ORR)
Tidsramme: Up to 3 years
ORR was defined as the percentage of participants whose best overall response (BOR) was confirmed to be complete response (CR) or partial response (PR) from the first dose of poziotinib until the last tumor assessment on study. ORR was assessed by the Independent Radiologic Review Committee according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all non-nodal target lesions. Any pathological lymph nodes must have become normal (i.e., decrease in the short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD. Additionally, progression of target lesions must not have been present.
Up to 3 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: Up to 5 years
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were defined as AEs that occur from the first dose of study treatment until 35 (±5) days after the last dose of study treatment.
Up to 5 years
Disease Control Rate (DCR)
Tidsramme: Up to 3 years
DCR was defined as percentage of participants with best response of CR, PR, or stable disease (SD) from the first dose of poziotinib to the last tumor assessment on study. CR was defined as the disappearance of all non-nodal target lesion. Any pathological lymph nodes must have become normal (i.e., decrease in the short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD. Additionally, progression of target lesions must not have been present. SD was defined as neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
Up to 3 years
Duration of Response (DoR)
Tidsramme: Up to 3 years
DoR was evaluated only for participants who had CR or PR and was defined as the time from the date that response evaluation criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that PD or death was documented. CR was defined as the disappearance of all non-nodal target lesion. Any pathological lymph nodes must have become normal (i.e., decrease in the short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD. Additionally, progression of target lesions must not have been present. Disease progression was defined as greater than or equal to (≥) 20% increase in the SOD of target lesions taking as reference the nadir SOD (or the baseline, if the baseline is the nadir value). In addition to the relative increase of 20% in SOD, the SOD must also have demonstrated an absolute increase of ≥ 5 mm.
Up to 3 years

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free Survival (PFS) - Exploratory
Tidsramme: Up to 3 years
PFS was defined as the time (in months) from the treatment start date to the first date of documented PD or death. Disease progression was defined as ≥20% increase in the SOD of target lesions taking as reference the nadir SOD (or the baseline if the baseline is the nadir value). In addition to the relative increase of 20% in SOD, the SOD must also have demonstrated an absolute increase of ≥ 5 mm.
Up to 3 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Spectrum Pharmaceuticals, Inc

Efterforskere

  • Studieleder: Lyndah Dreiling, MD, Spectrum Pharmaceuticals, Inc

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

11. oktober 2017

Primær færdiggørelse (Faktiske)

3. april 2023

Studieafslutning (Faktiske)

3. april 2023

Datoer for studieregistrering

Først indsendt

10. oktober 2017

Først indsendt, der opfyldte QC-kriterier

20. oktober 2017

Først opslået (Faktiske)

24. oktober 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SPI-POZ-202

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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CROs by country

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