Not yet recruitingNCT07929740ClinicalTrials.gov record

Bioavailability and Bioequivalence Study of Ziftomenib in Participants With Relapsed/Refractory AML or MDS

Myelodysplastic Syndrome (MDS)/AML · Myeloid Leukemia, Acute

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Phase 1
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 126 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This study will evaluate the pharmacokinetics (PK) of ziftomenib drug products to inform relative bioavailability (rBA) and bioequivalence (BE) assessments.

Read the full description

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

1. Age ≥18 years.
2. 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).
3. Female participants must not be pregnant or breastfeeding.
4. 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.
5. Signed informed consent.
6. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and life expectancy ≥2 months.
7. 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.
8. 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:

1. Clinically active central nervous system (CNS) leukemia; participants with controlled CNS leukemia receiving intrathecal therapy at study entry may be eligible.
2. Grade ≥2 acute graft-versus-host disease (GVHD), moderate/severe limited chronic GVHD, or extensive chronic GVHD.
3. Active HIV, hepatitis C, or hepatitis B infection, as defined in the protocol; participants with controlled disease are not excluded.
4. Active, uncontrolled systemic fungal, bacterial, viral, or other infection.
5. 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.
6. 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.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: No masking

Cohort A

Sequential administration of oral formulations (Part 1) followed by optional treatment continuation (Part 2)

Drug: Ziftomenib

Cohort B

Sequential administration of oral formulations (Part 1) followed by optional treatment continuation (Part 2)

Drug: Ziftomenib

Cohort C

Sequential administration of oral formulations (Part 1) followed by optional treatment continuation (Part 2)

Drug: Ziftomenib

Ziftomenib DRUG

Oral Formulation 1

Ziftomenib DRUG

Oral Formulation 2

Ziftomenib DRUG

Oral Formulation 3

Ziftomenib DRUG

Oral Formulation 4

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

To determine the plasma PK parameters of ziftomenib following oral (PO) administration (Part 1: Cohorts A, B and C)