Bioavailability and Bioequivalence Study of Ziftomenib in Participants With Relapsed/Refractory AML or MDS
5 november 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
126
Fas
- Fas 1
Utökad åtkomst
Tillgängligt utanför den kliniska prövningen.
Se utökad åtkomstpost.
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 |
|
Experimentell: 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 |
|
Experimentell: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
To determine the plasma PK parameters of ziftomenib following oral (PO) administration (Part 1: Cohorts A, B and C)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: During the first 56 days of ziftomenib
|
Cavg,ss |
During the first 56 days of ziftomenib
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
To determine the plasma PK parameters of ziftomenib following oral (PO) administration (Part 1: Cohort C)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
30 oktober 2026
Primärt slutförande (Beräknad)
28 februari 2029
Avslutad studie (Beräknad)
28 februari 2029
Studieregistreringsdatum
Först inskickad
21 oktober 2026
Först inskickad som uppfyllde QC-kriterierna
5 november 2026
Första postat (Faktisk)
10 november 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 november 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 november 2026
Senast verifierad
1 oktober 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KO-MEN-018
- 2025 (U.S.S. NIH-anslag/kontrakt)
- 2025-524332-19-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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