NCT00097903已完成1 期
Phase 1 Trial of Oral Karenitecin® in Patients With Solid Tumors"
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Overall Safety and determination of MTD, and recommended Phase 2 dose
研究概览
简要总结
The purpose of this study is to determine the maximum safe dose of orally administered Karenitecin (BNP1350) in patients with solid tumors.
详细描述
Initially, the safety, side effects and recommended phase 2 dose of oral Karenitecin in patients with advanced solid tumors will be determined.
When the recommended phase 2 dose has been determined, the specified dose will be used to determine if Karenitecin is effective in the treatment of patients with relapsed or refractory non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 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
- 未提供
排除标准
- •Pregnant or lactating women.
- •Uncontrolled high blood pressure, uncontrolled diabetes mellitus, unstable angina, symptomatic congestive heart failure (CHF), myocardial infarction (MI) within 6 months, or uncontrolled arrhythmia.
- •Phase 2 no previous or concurrent malignancy
- •Central Nervous System (CNS) metastasis if neurologically unstable or requiring steroid use.
- •Active infection.
- •Known positive HIV status.
- •Conditions requiring use of H2 blockers or other antacids.
- •Inability to provide informed consent.
研究组 & 干预措施
1
Experimental
Karenitecin IV/ Karenitecin tablet
干预措施: Karenitecin (BNP1350) (Drug)
结局指标
主要结局
Overall Safety and determination of MTD, and recommended Phase 2 dose
时间窗: throughout study
次要结局
- Tumor response(various timepoints)
- Pharmacokinetics(various timepoints)
研究者
研究点 (1)
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