NCT00585416终止2 期
A Phase II Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer (47-02-001)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
The purpose of this research is to determine the effectiveness of CGC-11047 in subjects with metastatic hormone refractory prostate cancer as measured by changes in PSA.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Metastatic hormone refractory prostate cancer.
- •Eastern Cooperative Oncology Group (ECOG) Performance status of 0-
- •testosterone <50ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone orchiectomy.
- •Progressive disease after androgen deprivation.
排除标准
- •Patients whose clinical condition would make chemotherapy clearly indicated.
- •Patients who have received systemic chemotherapy for the treatment of metastatic disease.
- •Peripheral neuropathy > Grade 1
- •Prior anti-angiogenic therapy, including thalidomide.
- •Patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure or radiation within 4 weeks prior to study entry.
- •Patients who have received radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
- •Patients with known brain metastases or history of brain metastases.
- •History of stroke within 6 months of treatment or other significant neurological limitations.
- •Patients who have received more than 2 prior investigational treatments.
- •Uncontrolled intercurrent illness
- •Patients with a history of a myocardial infarction within the prior 6 months or, hospitalizations for decompensated congestive heart failure within the prior 6 months, or history of significant / symptomatic cardiac arrhythmias
研究组 & 干预措施
1
Experimental
CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle)
干预措施: CGC-11047 (Drug)
结局指标
主要结局
Efficacy
时间窗: 8 weeks
次要结局
- Safety(Throughout and for 28 days post drug)
研究者
研究点 (1)
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