NCT00088023终止1 期
A Phase I Study of PT-523 in Patients With Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 6
研究概览
简要总结
The purpose of this study is to determine the safety of a short intravenous infusion of PT-523 to patients with solid tumors who have failed curative or survival prolonging therapy or for whom no such therapies exist.
详细描述
The primary objectives of this study are 1) to evaluate the safety of a short intravenous infusion of PT-523 when administered on days 1, 8, and 15 of a 28-day cycle to patients with solid tumors who have failed curative or survival prolonging therapy or for whom no such therapies exist; and 2) to establish the maximum tolerated dose (MTD) and identify the dose limiting toxicities (DLT) of PT-523.
The secondary objectives of this study are to determine the pharmacokinetics and to evaluate preliminary efficacy of PT-523.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Presence of metastatic or inoperable malignancy, other than leukemia or a primary central nervous system (CNS) tumor, for which there is no known curative or survival prolonging palliative therapy, or failure of these therapies .
- •Age greater than or equal to 18 years.
- •Life expectancy greater than or equal to 2 months.
- •ECOG performance status 0 -
- •Adequate organ function and bone marrow reserve.
- •Use of appropriate contraceptive method.
- •Sign patient informed consent.
排除标准
- •Active brain metastases.
- •Presence of third-space fluid collections (pleural effusion, ascites).
- •Major surgery within 3 weeks prior to dosing.
- •Prior chemotherapy or radiation therapy within 3 weeks prior to dosing (6 weeks for nitrosoureas or mitomycin-C). Prior antifolate therapy is permitted, as long as it has not been administered within 3 weeks prior to dosing with PT-
- •Prior bone marrow transplantation.
- •Presence of uncontrolled serious medical or psychiatric illness.
- •Patients requiring radiation therapy.
- •There are no limitations on the extent or type of prior therapy received by the patient other than the time intervals indicated above, as long as the patient has demonstrated complete recovery from any adverse effects, and fulfills all relevant inclusion criteria.
研究者
研究点 (6)
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