NCT01242072Unknown1 期
A Phase I Study of Intravenous (IV) Palifosfamide-tris Administered in Combination With IV Etoposide and IV Carboplatin in Patients With Malignancies for Which Etoposide and Carboplatin Are an Appropriate Choice
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Assess the safety profile
研究概览
简要总结
This an an open-label study to define the safety profile and the maximum tolerated dose and confirm the clinical effective dose of palifosfamide-tris given intravenously in combination with etoposide and carboplatin in a wide range of cancers which etoposide and carboplatin are normally given. Once the maximum dose of palifosfamide-tris is determined,a Phase II study using the 3 agents combined will begin.
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
- •18 years old or greater
- •Malignancy scheduled to receive etoposide and carboplatin therapy
- •Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1
- •Adequate bone marrow, liver, renal function and coagulation status
- •Informed consent
- •Agree to use birth control through 28 days of last treatment dose
- •Pregnancy test for women of child-bearing potential
- •No available standard therapy
排除标准
- •Allergy to the the study treatment drugs
- •Unstable current medical condition
- •Presence or history of injury to the urinary tract
- •Active infection
- •Major surgery within 4 weeks prior to treatment
- •Minor surgery within 2 weeks prior to treatment
- •Current acute steroid therapy or taper
- •Currently pregnant or nursing
- •Substance abuse or condition that may interfere with participation
- •Received other investigational drugs within 30 days
- •Within 4 weeks of their last chemotherapy
研究组 & 干预措施
PaCE
Experimental
Palifosfamide, Carboplatin and Etoposide
干预措施: palifosfamide-tris (Drug)
结局指标
主要结局
Assess the safety profile
时间窗: 21 Days
Adverse events, vital signs, physical examination, laboratory data and concomitant medications
次要结局
- Determine the maximum tolerated dose(Up to 21 days)
- Assess early signs of efficacy(duration of study)
研究者
研究点 (4)
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