NCT00303199已完成1 期
A Phase I/II Trial of ZIO-101 in Advanced Multiple Myeloma
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
- 35
- 主要终点
- Phase I: toxicity defined in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) 12/12/03
研究概览
简要总结
The study of safety of a new organic arsenic compound in the treatment of advanced multiple myeloma
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single Arm
Experimental
干预措施: ZIO-101 (Darinaparsin) (Drug)
结局指标
主要结局
Phase I: toxicity defined in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) 12/12/03
时间窗: 6 months
Phase II efficacy using EMBT criteria.
时间窗: 6 months
Safety
时间窗: 6 months
次要结局
- Pharmacokinetics of ZIO-101(6 months)
研究者
相似试验
Unknown
2 期
A Phase II Trial of ZIO-101 in Advanced Multiple Myeloma: Protocol SGL2001bMultiple MyelomaNCT00423644Alaunos Therapeutics17
已完成
2 期
Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow CancersHematologic NeoplasmsBone Marrow NeoplasmsNon-Hodgkin's LymphomaNCT00421213Alaunos Therapeutics50
Unknown
2 期
A Phase-II Trial of ZIO 101 in Advanced Hepatocellular CarcinomaHEPATOCELLULAR CARCINOMANCT00423306Alaunos Therapeutics15
终止
1 期
Trisenox, Ascorbic Acid and Bortezomib in Patients With Relapsed/Refractory Multiple MyelomaMultiple MyelomaNCT00590603Duke University25
终止
2 期
Antineoplaston Therapy in Treating Patients With Multiple MyelomaMultiple MyelomaNCT00003511Burzynski Research Institute5