Bioavailability and Bioequivalence Study of Ziftomenib in Participants With Relapsed/Refractory AML or MDS
5. november 2026 opdateret af: Kura Oncology, Inc.
Relative Bioavailability and Bioequivalence Study of Ziftomenib Drug Products in Participants With Relapsed/Refractory AML With NPM1 Mutation, or With Relapsed/Refractory AML or MDS With Mutations Associated With MEIS1 Overexpression
This study will evaluate the pharmacokinetics (PK) of ziftomenib drug products to inform relative bioavailability (rBA) and bioequivalence (BE) assessments.
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Detaljeret beskrivelse
The purpose of this study is to measure rBA or BE of various ziftomenib drug products in participants with R/R NPM1-m AML, or with R/R AML or MDS with a mutation associated with MEIS1 overexpression.
Study details include:
- The study is composed of two parts.
- Participant study duration will be a minimum of approximately 4 months including screening, 2 cycles of treatment, and safety follow-up.
- The visit frequency will be weekly in Part 1.
- The required treatment duration will be approximately 2 cycles of treatment (56 days) in Part 1 with the option for participants deriving clinical benefit to continue treatment in Part 2.
- The visit frequency will be monthly in Part 2.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
126
Fase
- Fase 1
Udvidet adgang
Ledig uden for det kliniske forsøg.
Se udvidet adgangsregistrering.
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
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age ≥18 years.
- Relapsed/refractory NPM1-mutated AML, or relapsed/refractory AML or MDS with a mutation associated with MEIS1 overexpression; disease confirmed in blood and/or bone marrow, as applicable, and not a candidate for currently approved standard-of-care regimens or hematopoietic stem cell transplantation (HSCT).
- Female participants must not be pregnant or breastfeeding.
- Male participants with partners of childbearing potential must agree to abstinence or highly effective contraception and refrain from sperm donation during treatment and for at least 90 days after the last dose.
- Signed informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and life expectancy ≥2 months.
- Adequate organ function: estimated glomerular filtration rate ≥30 mL/min/1.73 m²; bilirubin ≤1.5 × the upper limit of normal (ULN), unless attributable to Gilbert's syndrome or leukemic disease; and AST and ALT ≤3 × ULN.
- Peripheral white blood cell count ≤25,000/µL before Day 1 of Part 1; hydroxyurea or cytarabine may be used to control the count.
Exclusion Criteria:
- Clinically active central nervous system (CNS) leukemia; participants with controlled CNS leukemia receiving intrathecal therapy at study entry may be eligible.
- Grade ≥2 acute graft-versus-host disease (GVHD), moderate/severe limited chronic GVHD, or extensive chronic GVHD.
- Active HIV, hepatitis C, or hepatitis B infection, as defined in the protocol; participants with controlled disease are not excluded.
- Active, uncontrolled systemic fungal, bacterial, viral, or other infection.
- Significant cardiovascular disease, including unstable angina, uncontrolled hypertension or arrhythmia, qualifying heart failure, ischemic or severe valvular heart disease, or stroke, transient ischemic attack, or myocardial infarction within the preceding 6 months.
- Mean QT interval corrected using Fridericia's formula (QTcF) >480 ms on triplicate electrocardiograms obtained within 5 minutes of each other.
The full inclusion and exclusion criteria, including applicable definitions are presented in the study protocol.
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: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Cohort A
Sequential administration of oral formulations (Part 1) followed by optional treatment continuation (Part 2) |
Oral Formulation 1 Oral Formulation 2 Oral Formulation 3 Oral Formulation 4 |
|
Eksperimentel: Cohort B
Sequential administration of oral formulations (Part 1) followed by optional treatment continuation (Part 2) |
Oral Formulation 1 Oral Formulation 2 Oral Formulation 3 Oral Formulation 4 |
|
Eksperimentel: Cohort C
Sequential administration of oral formulations (Part 1) followed by optional treatment continuation (Part 2) |
Oral Formulation 1 Oral Formulation 2 Oral Formulation 3 Oral Formulation 4 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To determine the plasma PK parameters of ziftomenib following oral (PO) administration (Part 1: Cohorts A, B and C)
Tidsramme: During the first 56 days of ziftomenib
|
Maximum plasma concentration at steady state (Cmax,ss) |
During the first 56 days of ziftomenib
|
|
To determine the plasma PK parameters of ziftomenib following oral (PO) administration (Part 1: Cohorts A and B)
Tidsramme: During the first 56 days of ziftomenib
|
Plasma concentration observed at end of dosing interval at steady state (Cτ) |
During the first 56 days of ziftomenib
|
|
To determine the plasma PK parameters of ziftomenib following oral (PO) administration (Part 1: Cohorts A, B and C)
Tidsramme: During the first 56 days of ziftomenib
|
Area under the concentration-time curve from time 0 to dosing interval at steady state (AUC0-τ,ss) |
During the first 56 days of ziftomenib
|
|
To determine the plasma PK parameters of ziftomenib following oral (PO) administration (Part 1: Cohorts A and B)
Tidsramme: During the first 56 days of ziftomenib
|
Time to Cmax,ss (Tmax,ss) |
During the first 56 days of ziftomenib
|
|
To determine the plasma PK parameters of ziftomenib following oral (PO) administration (Part 1: Cohorts A and B)
Tidsramme: During the first 56 days of ziftomenib
|
Cavg,ss |
During the first 56 days of ziftomenib
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To determine the plasma PK parameters of ziftomenib following oral (PO) administration (Part 1: Cohort C)
Tidsramme: During the first 56 days of ziftomenib
|
Cτ |
During the first 56 days of ziftomenib
|
|
To determine the plasma PK parameters of ziftomenib following oral (PO) administration (Part 1: Cohort C)
Tidsramme: During the first 56 days of ziftomenib
|
Tmax,ss |
During the first 56 days of ziftomenib
|
|
To determine the plasma PK parameters of ziftomenib following oral (PO) administration (Part 1: Cohort C)
Tidsramme: During the first 56 days of ziftomenib
|
Cavg,ss |
During the first 56 days of ziftomenib
|
|
To assess safety and tolerability of ziftomenib (Parts 1 and 2)
Tidsramme: Day 1 of study intervention through 28 days after the last dose
|
|
Day 1 of study intervention through 28 days after the last dose
|
|
To assess discontinuation of study treatment due to Adverse Events (Parts 1 and 2)
Tidsramme: Day 1 of study intervention through 28 days after the last dose
|
Discontinuation of study treatment due to AEs |
Day 1 of study intervention through 28 days after the last dose
|
|
To assess deaths while receiving treatment (Parts 1 and 2)
Tidsramme: Day 1 of study intervention through 28 days after the last dose
|
Deaths on treatment |
Day 1 of study intervention through 28 days after the last dose
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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 (Anslået)
30. oktober 2026
Primær færdiggørelse (Anslået)
28. februar 2029
Studieafslutning (Anslået)
28. februar 2029
Datoer for studieregistrering
Først indsendt
21. oktober 2026
Først indsendt, der opfyldte QC-kriterier
5. november 2026
Først opslået (Faktiske)
10. november 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. november 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KO-MEN-018
- 2025 (U.S. NIH-bevilling/kontrakt)
- 2025-524332-19-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
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