临床试验/NCT00111683

NCT00111683已完成1 期

A Phase I/II Dose Escalation Study of MK0457 in Patients With Leukemia

Merck Sharp & Dohme LLC0 个研究点目标入组 28 人开始时间: 2005年6月最近更新: 2015年8月25日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 28
主要终点: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

In this study participants with relapsed/refractory leukemia will be given MK-0457 in sequential cohorts and with varying treatment duration to determine the maximum tolerated dose (MTD) for MK-0457.

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

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

•Patients with relapsed/refractory acute myelogenous leukemia (AML), poor risk myelodysplastic syndrome (MDS), B-cell acute lymphocytic leukemia (ALL), myeloproliferative diseases, or chronic myelogenous leukemia (CML) in blast crisis
•Acute myelogenous leukemia (with FLT-3 mutation ), and myeloproliferative diseases only
•At least 2 weeks since the last cytotoxic therapy
•Acceptable renal and hepatic function
•Ambulatory, capable of all self-care, and out of bed for more than 50% of waking hours
•More than 2 months since autologous bone marrow or peripheral blood stem cell transplantation

排除标准

•Not fully recovered from previous anti-leukemia therapy
•Previous allogeneic bone marrow transplant
•Uncontrolled congestive heart failure
•Myocardial infarction within the last 3 months
•Active or uncontrolled infection
•Pregnancy or lactation
•Currently active second malignancy, other than non-melanoma skin cancer
•History of hepatitis B or C, known HIV positivity, or AIDS related illness

研究组 & 干预措施

MK-0457

Experimental

Participants receive MK-0457 as a continuous intravenous infusion (CIV) at assigned dose and duration

干预措施: MK0457 (Drug)

结局指标

主要结局

Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

时间窗: Part 1: up to 5 days, Part 2: up to 24 hours

次要结局

Hematological response rate to MK-0457 as a 5-day CIV infusion(At the end of each cycle (up to 18 months))

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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