NCT00477282已完成3 期
A Phase 3 Study of Safety and Efficacy of Karenitecin Versus Topotecan Administered for 5 Consecutive Days Every 3 Weeks in Patients With Advanced Epithelial Ovarian Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 509
- 主要终点
- Progression Free Survival
研究概览
简要总结
The objective of this study is to assess the safety and efficacy of karenitecin versus topotecan in patients with platinum/taxane-resistant advanced epithelial ovarian cancer. Additionally, this study will assess the ability of karenitecin to extend the time to disease progression, extend the overall survival time, and reduce the incidence and severity of treatment related hematological toxicities in patients with advanced epithelial ovarian cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Confirmed diagnosis of stage III or IV epithelial ovarian cancer
- •Have cancer that is resistant to platinum/taxane-based chemotherapy regimens
- •Have measurable, progressive disease
- •Have an ECOG PS ≤ 2
排除标准
- •Have uncontrolled high blood pressure, uncontrolled diabetes mellitus, or other serious underlying medical condition not compatible with study entry.
- •Have a life expectancy < 3 months
- •Received prior treatment with a camptothecin (topotecan, CPT-11, or investigational camptothecins).
- •Received prior treatment with any platinum agent other than cisplatin or carboplatin.
- •Received prior radiation therapy to greater than one-third of the hematopoietic sites (one-third of the pelvis and axial skeleton combined).
研究组 & 干预措施
Karenitecin
Experimental
干预措施: Karenitecin (Drug)
Topotecan
Active Comparator
干预措施: Topotecan (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: baseline to measured progressive disease
次要结局
- Incidence of Neutropenia(Active treatment period (SAEs and on-going treatment-related AEs at end of treatment will be followed until resolution. All other AEs will be followed for up to 30 days after last treatment administration)
- Overall Survival(baseline to date of death from any cause)
- Incidence of Anemia(Active treatment period (SAEs and on-going treatment-related AEs at end of treatment will be followed until resolution. All other AEs will be followed for up to 30 days after last treatment administration.)
- Incidence of Thrombocytopenia(Active treatment period (SAEs and on-going treatment-related AEs at end of treatment will be followed until resolution. All other AEs will be followed for up to 30 days after last treatment administration)
研究者
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