Aún no reclutaNCT07929740Registro de ClinicalTrials.gov

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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LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: Fase 1
Rango de edad: 18 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 126 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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

Leer la descripción completa

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Sin enmascaramiento

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

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

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