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

2026年11月5日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

126

阶段

  • 阶段1

扩展访问

可用的 查看扩展访问记录。

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Cohort A

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

Oral Formulation 1

药品：Ziftomenib

Oral Formulation 2

药品：Ziftomenib

Oral Formulation 3

药品：Ziftomenib

Oral Formulation 4
实验性的：Cohort B

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

Oral Formulation 1

药品：Ziftomenib

Oral Formulation 2

药品：Ziftomenib

Oral Formulation 3

药品：Ziftomenib

Oral Formulation 4
实验性的：Cohort C

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

Oral Formulation 1

药品：Ziftomenib

Oral Formulation 2

药品：Ziftomenib

Oral Formulation 3

药品：Ziftomenib

Oral Formulation 4

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
To determine the plasma PK parameters of ziftomenib following oral (PO) administration (Part 1: Cohorts A, B and C)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：During the first 56 days of ziftomenib

Cavg,ss
During the first 56 days of ziftomenib

次要结果测量

结果测量
措施说明
大体时间
To determine the plasma PK parameters of ziftomenib following oral (PO) administration (Part 1: Cohort C)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：Day 1 of study intervention through 28 days after the last dose
  1. Incidence and severity of AEs per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) V6.0
  2. Incidence of SAEs
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)
大体时间：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)
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Kura Oncology, Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月30日

初级完成 (估计的)

2029年2月28日

研究完成 (估计的)

2029年2月28日

研究注册日期

首次提交

2026年10月21日

首先提交符合 QC 标准的

2026年11月5日

首次发布 (实际的)

2026年11月10日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • KO-MEN-018
  • 2025 (美国 NIH 拨款/合同)
  • 2025-524332-19-00 (克蒂斯)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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