A Phase I-II Study of Triciribine Phosphate Monohydrate (PTX-200) Plus Cytarabine in Refractory or Relapsed Acute Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Treatment-related Adverse Events
研究概览
简要总结
A phase I-II open label study of PTX-200 in combination with cytarabine in the treatment of relapsed or refractory acute leukemia.
详细描述
Study design: Phase I/II study The Phase I study is open-label with four increasing dose levels for up to four 21-day cycles. Safety and activity will be evaluated at the end of each cycle.
The Phase II study is open label with administration of the recommended phase dose of PTX-200 for up to four 21-day cycles. PTX-200 will be co-administered with cytarabine in both the Phase I and Phase II parts of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologic confirmation of the diagnosis of AML, ALL (acute lymphoblastic leukemia), or blast-phase CML (chronic myelogenous leukemia)
- •Age ≥ 18 years
- •ECOG Performance Status 0-2
- •Patients must be able to give adequate informed consent
排除标准
- •Hyperleukocytosis with ≥ 30,000 leukemic blasts/µL blood (hydroxyurea permitted up to 24 hours prior to beginning study drugs)
- •Uncontrolled Disseminated Intravascular Coagulation (DIC)
- •Uncontrolled diabetes mellitus
- •Active, uncontrolled infection
研究组 & 干预措施
PTX-200 and cytarabine
PTX-200 administered intravenously over 1 hour
Phase I: 4 dose levels: 25 to 55 mg/m2 (with reduction to 15 mg/m2 if needed.
Phase II: maximum tolerated dose. given as a 1 hour infusion
Cytarabine administered by continuous infusion at a dose of 400 mg/m2/day for 4 days.
干预措施: PTX-200 (Drug)
PTX-200 and cytarabine
PTX-200 administered intravenously over 1 hour
Phase I: 4 dose levels: 25 to 55 mg/m2 (with reduction to 15 mg/m2 if needed.
Phase II: maximum tolerated dose. given as a 1 hour infusion
Cytarabine administered by continuous infusion at a dose of 400 mg/m2/day for 4 days.
干预措施: Cytarabine (Drug)
结局指标
主要结局
Treatment-related Adverse Events
时间窗: 12 months
Number of participants with treatment-related Adverse Events as assessed by CTCAE v4.0 that result in dose-limitations (Phase I)
次要结局
- Phospho-Akt (pAkt) expression within CD34+ leukemic blasts(12 months)