NCT00421213已完成2 期
Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Response Rate
研究概览
简要总结
The study of safety of a new organic arsenic compound in the treatment of hematological malignancies.
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
- •Hodgkin's or non-Hodgkin's Lymphoma.
- •≥ 1 prior therapy and currently requiring therapy.
- •Evaluable disease (defined by disease-specific criteria listed in Appendix 1)
- •≥ 18 years of age.
- •ECOG performance score ≤ 2 (see Appendix 2).
- •Life-expectancy ≥ 2 months.
- •Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee with jurisdiction over the site.
- •No anti-cancer therapy exception of hydroxyurea ≤ 3 weeks before Baseline (Day 1, Cycle 1).
- •The following clinical laboratory values < 2 weeks before Baseline:
- •Creatinine ≤ 2X upper limit of normal (ULN).
- •Total bilirubin ≤ 2X ULN.
- •Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3X ULN.
排除标准
- •New York Heart Association (NYHA) functional class ≥3 myocardial infarction (see Appendix ) within 6 months before Baseline or uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; a QTc ≥450 msec; or a ≥grade-2 atrioventricular (AV) block or left bundle branch block (LBBB).
- •Pregnant and/or lactating female. (Women of childbearing age must use effective contraception from Screening through the duration of study participation).
- •Uncontrolled infection.
- •Prior seizures ≥ grade-3 in CTC v.3 criteria.
- •Arsenic allergy.
- •Significant neuropathology, defined as grade > 2 per CTCAE Version 3.
- •Confusion or dementia.
- •Prior history of neurological deficits (e.g., stroke, dementia, ischemia) that has the potential to confound a post-dose neurological assessment.
研究组 & 干预措施
Single Arm
Experimental
干预措施: Darinaparsin (Drug)
结局指标
主要结局
Response Rate
时间窗: 6 months
次要结局
- toxicities(6 months)
研究者
研究点 (6)
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