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Bomedemstat hos patienter med polycytæmi Vera

16. april 2026 opdateret af: Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)

Et fase 2 multicenter, åbent label-studie til vurdering af sikkerhed, effektivitet, farmakokinetik og farmakodynamik af Bomedemstat hos patienter med polycytæmi Vera (PV)

Dette er et fase 2 åbent studie af en oralt administreret LSD1-hæmmer, bomedemstat (IMG-7289), hos patienter med polycytæmi vera.

Denne undersøgelse undersøger følgende:

  • Sikkerheden og tolerabiliteten af ​​bomedemstat
  • Den farmakodynamiske virkning af bomedemstat

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dette er et fase 2 multicenter, åbent studie, der evaluerer sikkerheden, effektiviteten, farmakokinetikken og farmakodynamikken af ​​bomedemstat administreret oralt én gang dagligt til patienter med polycytæmi vera.

Patienterne vil modtage 36 ugers dosering og kan kvalificere sig til yderligere behandling derefter.

Patienterne vil blive fulgt tæt gennem hele undersøgelsen for begge bivirkninger ved hyppig overvågning af kliniske tegn og symptomer samt sikkerhedslaboratorier. Effektivitet og farmakodynamiske virkninger vil blive nøje overvåget ved hyppige hæmatologiske vurderinger af perifert blod. Gennem hele doseringen kan transfusioner eller flebotomi administreres, hvis det er nødvendigt i overensstemmelse med standard institutionelle retningslinjer.

For at sikre sikkerheden vil et Safety Advisory Board udføre periodiske gennemgange af sikkerhedsparametre og farmakodynamiske markører.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Australien
    • Queensland
      • Sunshine Coast, Queensland, Australien, 4556
        • Sunshine Coast Hematology and Oncology Clinic (Site 0506)
    • Victoria
      • Clayton, Victoria, Australien, 3168
        • Monash Medical Centre ( Site 0006)
    • Western Australia
      • Perth, Western Australia, Australien, 6000
        • Royal Perth Hospital ( Site 0504)
  • Det Forenede Kongerige
    • England
      • Gloucester, England, Det Forenede Kongerige, GL1 3NN
        • Gloucestershire Royal Hospital ( Site 0205)
    • Great Britain
      • Lincoln, Great Britain, Det Forenede Kongerige, LN2 5QY
        • United Lincolnshire Hospitals NHS Trust ( Site 0204)
      • London, Great Britain, Det Forenede Kongerige, W12 0HS
        • Imperial College London ( Site 0025)
    • Lincolnshire
      • Boston, Lincolnshire, Det Forenede Kongerige, PE21 9QS
        • Boston Pilgrim Hospital ( Site 0207)
    • London, City of
      • London, London, City of, Det Forenede Kongerige, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust - Guys Hospital ( Site 0020)
    • Wales
      • Newport, Wales, Det Forenede Kongerige, NP9 2UB
        • Royal Gwent Hospital ( Site 0201)
  • Forenede Stater
    • Florida
      • Plantation, Florida, Forenede Stater, 33322
        • BRCR Global ( Site 0120)
    • Illinois
      • Skokie, Illinois, Forenede Stater, 60076-1264
        • Hematology Oncology of the North Shore ( Site 0104)
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan Comprehensive Cancer Center ( Site 0008)
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Comprehensive Cancer Centers of Nevada - Peak ( Site 0118)
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27705
        • Duke University Medical Center ( Site 0016)
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43203
        • Ohio State University Comprehensive Cancer Center ( Site 0103)
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239-4503
        • OHSU Knight Cardiovascular Institute Cardiology Clinic - South Waterfront ( Site 0102)
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Huntsman Cancer Hospital at the University of Utah ( Site 0119)

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

Inklusionskriterier:

  • Diagnose af polycytæmi Vera i henhold til Verdenssundhedsorganisationens (WHO) diagnostiske kriterier for myeloproliferative neoplasmer
  • Knoglemarvsfibrose-score af grad 0 eller grad 1
  • Patienter, der har svigtet mindst én standard cytoreduktiv behandling for at sænke hæmatokrit
  • Blodpladeantal ≥250 x 10ˆ9/L
  • Absolut neutrofiltal (ANC) ≥1,5 x 10ˆ9/L
  • Forventet levetid >36 uger.
  • Skal have afbrudt forudgående cytoreduktiv behandling i 2 uger (4 uger for interferon) før påbegyndelse af undersøgelseslægemidlet.

Ekskluderingskriterier:

  • Eastern Cooperative Oncology Group (ECOG) præstationsstatus på 3 eller højere
  • Uafklarede behandlingsrelaterede toksiciteter fra tidligere behandlinger (medmindre de er løst til ≤ grad 1).
  • Ukontrolleret aktiv infektion.
  • Nuværende brug af forbudte medicin
  • Kendt HIV-infektion eller aktiv Hepatitis B- eller Hepatitis C-virusinfektion
  • Tegn på øget risiko for blødning, herunder kendte blødningsforstyrrelser
  • Andre hæmatologiske/biokemiske krav i henhold til protokol
  • Drægtige eller ammende hunner

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Bomedemstat
Deltagerne vil modtage bomedemstat dagligt i 36 uger og kan kvalificere sig til yderligere behandling gennem uge 52, hvis de opnår klinisk fordel.
Medicin: Bomedemstat
Oral kapsel
Andre navne:
  • IMG-7289
  • MK-3543

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Adverse Events (AEs)
Tidsramme: Up to approximately 52 weeks
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with one or more AEs are reported.
Up to approximately 52 weeks
Number of Participants Who Discontinued Study Intervention Due to AEs
Tidsramme: Up to approximately 52 weeks
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study intervention due to an AE are reported.
Up to approximately 52 weeks
Percentage of Participants With Sustained 12-week Reduction of Hematocrit (Hct) to <45% Without Concomitant Phlebotomy by Week 36
Tidsramme: Up to approximately 36 weeks
Hematocrit (Hct) was analyzed by taking blood samples from participants at designated time points during the study. Participants were considered responders if they achieved a sustained reduction of Hct to <45% for 12 weeks (84 calendar days) by Week 36 AND there was no concomitant phlebotomy performed during the sustained reduction. Baseline data was defined as the data most recently collected prior to the first dose. A Clopper-Pearson (exact binomial) two-sided 95% confidence interval for the percentage of responders was presented. The percentage of participants who achieved a sustained 12-week reduction of Hct to <45% without concomitant phlebotomy at Week 36 are reported.
Up to approximately 36 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Duration of Reduction of Hematocrit (Hct) to <45% Without Phlebotomy
Tidsramme: Up to approximately 22 months
Total response duration was defined as the summation of all Hct <45% response durations, where an individual response duration starts at the timepoint where the Hct <45% and ends at the first subsequent occurrence of phlebotomy or Hct >=45%. Hct was analyzed by taking blood samples from participants at designated time points during the study. Duration of reduction of Hct to <45% without phlebotomy was presented.
Up to approximately 22 months
Percentage of Participants With Platelet Count ≤ 450 x 10^9/L by Week 36
Tidsramme: Up to approximately 36 weeks
Platelet count was analyzed by taking blood samples from participants at designated time points during the study. Participants who enter the study with platelet counts ≤450 X 10^9/L must achieve an additional on-study platelet count ≤450 X 10^9/L to be considered responders. A Clopper-Pearson (exact binomial) two-sided 95% confidence interval for the percentage of responders is presented. Baseline data was defined as the data most recently collected prior to the first dose. The percentage of participants who have a platelet count ≤450 X 10^9/L by week 36 are reported.
Up to approximately 36 weeks
Duration of Platelet Count ≤ 450 x 10^9/L
Tidsramme: Up to approximately 22 months
Total response duration was defined as the summation of all platelet ≤450 x 10^9/L response durations, where an individual response duration starts at the timepoint where platelet count ≤450 x 10^9/L and ends at the first subsequent occurrence of platelet >450 x 10^9/L. Platelet counts were analyzed by taking blood samples from participants at designated time points during the study. The duration of platelet count ≤450 X 10^9/L in participants are reported.
Up to approximately 22 months
Percentage of Participants With White Blood Cell (WBC) Count <10 x 10^9/L by Week 36
Tidsramme: Up to approximately 36 weeks
WBC count was analyzed by taking blood samples from participants at designated time points during the study. Participants who enter the study with WBC counts <10 X 10^9/L must achieve an additional on-study WBC count <10 X 10^9/L to be considered responders. A Clopper-Pearson (exact binomial) two-sided 95% confidence interval for the percentage of responders is presented. Baseline data was defined as the data most recently collected prior to the first dose. The percentage of participants who have a WBC count <10 X 10^9/L week 36 are reported.
Up to approximately 36 weeks
Duration of White Blood Cell (WBC) Count <10 x 10^9/L
Tidsramme: Up to approximately 22 months
Total response duration was defined as the summation of all WBC <10 x 10^9/L response durations, where an individual response duration starts at the timepoint when WBC <10 x 10^9/L and ends at the first subsequent occurrence of WBC ≥ 10 x 10^9/L. WBC count was analyzed by taking blood samples from participants at designated time points during the study. The duration of WBC count <10 X 10^9/L in participants are reported.
Up to approximately 22 months
Number of Participants With Thrombotic Events
Tidsramme: Up to approximately 22 months
Thrombotic events are defined as: new or recurrent acute myocardial infarction; unstable angina; stroke; transient ischemic attack (TIA); deep venous thrombosis (DVT); pulmonary embolism (PE); thrombotic digital ischemia; other thrombotic events such as peripheral limb ischemia or Budd-Chiari syndrome that are assessed to be due to underlying polycythemia vera (PV); other vascular occlusive events such as symptoms of cardiac, abdominal or peripheral limb ischemia supported by objective evidence of vessel disease and/or ischemia. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with thrombotic events are reported.
Up to approximately 22 months
Number of Participants With Major Hemorrhagic Events
Tidsramme: Up to approximately 22 months
Hemorrhagic events were defined as: Major Bleeding (MB) Events such as fatal bleeding, and/or symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin level of 2 g/dL or more, or leading to transfusion of 2 or more units of whole blood or red cells; Clinically Relevant Non-Major Bleeding (CRNMB) Events Leading to hospitalization or increased level of care or clinically important, prompting a face-to-face medical evaluation. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with major hemorrhagic events are reported.
Up to approximately 22 months
Number of Participants With an Enlarged Spleen at Baseline Who Had a Reduction in Splenic Volume by 36 Weeks
Tidsramme: Up to approximately 36 weeks
Spleen volume was measured by magnetic resonance imaging (MRI) (or computerized tomography [CT] if participant is not a candidate for MRI) of the abdomen according to standard procedures. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with an enlarged spleen at baseline (volume >450 cm^3) who achieved any reduction in spleen volume by Week 36 are reported.
Up to approximately 36 weeks
Number of Participants With Progressive Disease (PD)
Tidsramme: Up to approximately 52 weeks
PD was defined as the worsening of Polycythemia Vera (PV) to post-PV myelofibrosis, myelodysplastic syndrome or transformation to acute myeloid leukemia. Baseline data was defined as the data most recently collected prior to the first dose. The number of participants with PD are reported.
Up to approximately 52 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)

Efterforskere

  • Studieleder: Medical Director, Merck Sharp & Dohme LLC

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.

Hjælpsomme links

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)

7. september 2023

Primær færdiggørelse (Faktiske)

24. marts 2025

Studieafslutning (Faktiske)

10. juli 2025

Datoer for studieregistrering

Først indsendt

20. september 2022

Først indsendt, der opfyldte QC-kriterier

26. september 2022

Først opslået (Faktiske)

28. september 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 3543-004
  • IMG-7289-CTP-203 (Anden identifikator: Imagobio ID)
  • MK-3543-004 (Anden identifikator: MSD)
  • 2022-002262-32 (EudraCT nummer)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

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 .

Kliniske forsøg med Polycytæmi Vera

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