NCT00273338终止3 期
A Phase 3, Randomized, Open-Label Study Evaluating DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (ASCENT-2)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Novacea
- 入组人数
- 1,200
- 试验地点
- 429
研究概览
简要总结
The primary objective of this study is:
- To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on survival in metastatic androgen-independent prostate cancer
The secondary objectives of this study are:
- To determine the effect of the ASCENT regimen on the rate of thromboembolic events (blood clots)
- To determine the effect of the ASCENT regimen on prevention of skeletal-related events (fractures)
- A Separate sub-study will be conducted at selected study sites in North America to determine the population PK of DN-101.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Histopathologically or cytologically proven adenocarcinoma of the prostate
- •Documented metastatic prostate adenocarcinoma
- •Documented progression while on androgen ablation therapy detected by rising prostate specific antigen (PSA) and/or imaging
- •Age >= 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status <= 2
- •Adequate hematologic, renal and hepatic function
- •Life expectancy >= 3 months
排除标准
- •Prior chemotherapy, except estramustine
- •Prior chemotherapy with docetaxel
- •Prior isotope therapy (e.g., strontium-89, samarium-153, etc.)
- •One or more contraindications to the use of corticosteroids
- •History of cancer-related hypercalcemia
研究者
研究点 (429)
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