A Phase I Study Of PT523 In Patients With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as talotrexin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying side effects, best way to give, and best dose of talotrexin in treating patients with advanced or recurrent solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of talotrexin in patients in patients with advanced or recurrent solid tumors.
- Determine the safety of this drug in these patients.
- Determine the dose-limiting toxic effects of this drug in these patients.
Secondary
- Determine the pharmacokinetics of this drug in these patients.
- Correlate pharmacokinetic parameters of this drug or patient characteristics with drug-related toxicity in these patients.
- Determine, preliminarily, the antitumor efficacy of this drug in these patients.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dose Level 1a
10 mg/m2 dose of PT523 administered day 1 of a 28-day cycle as a 5 minute IV infusion (IV bolus)
干预措施: talotrexin ammonium (Drug)
Dose Level 1b
5 mg/m2 dose of PT523 administered days 1 and 8 of a 28-day cycle as a 5 minute IV infusion
干预措施: talotrexin ammonium (Drug)
Dose Level 1c
3.33 mg/m2 dose of PT523 administered days 1, 8 and 15 of a 28-day cycle as a 5 minute IV infusion
干预措施: talotrexin ammonium (Drug)
Dose Level 2
5 mg/m2 dose of PT523 administered days 1, 8 and 15 of a 28-day cycle as a 5 minute IV infusion
干预措施: talotrexin ammonium (Drug)
Dose Level 3
7.5 mg/m2 dose (or 6.7 mg/m2 depending on observed toxicity) of PT523 administered days 1, 8 and 15 of a 28-day cycle as a 5 minute IV infusion
干预措施: talotrexin ammonium (Drug)
Dose Level 4
11.25 mg/m2 dose (or 9 mg/m2 depending on observed toxicity) of PT523 administered days 1, 8 and 15 of a 28-day cycle as a 5 minute IV infusion
干预措施: talotrexin ammonium (Drug)
Dose Level 5
17 mg/m2 dose (or 12 mg/m2 depending on observed toxicity) of PT523 administered days 1, 8 and 15 of a 28-day cycle as a 5 minute IV infusion
干预措施: talotrexin ammonium (Drug)
研究者
Geoffrey Shapiro, MD, PhD
Director, Early Drug Development Center
Dana-Farber Cancer Institute