NCT00055471已完成2 期
A Phase IIa. Open-label, Multicenter, Dose-escalation Study to Assess the Tolerability and Pharmacokinetics of ZD4054 (Zibotentan) Given Orally Once Daily in Subjects With Metastatic Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicities (DLTs)
研究概览
简要总结
The primary purpose of this study is to determine the safest dose of ZD4054 (Zibotentan)in men with prostate cancer
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •Men 18 years & older
- •Confirmed diagnosis of prostate cancer with bone metastases
排除标准
- •No more than 2 prior chemotherapy regimens
- •No radiation, chemotherapy or bisphosphonates in the past 4 weeks
研究组 & 干预措施
ZD4054 10 mg
Experimental
1 x 10 mg oral tablets once daily
干预措施: ZD4054 10 mg (Drug)
ZD4054 15 mg
Experimental
1 x 10 mg + 2 x 2.5 mg oral tablets once daily
干预措施: ZD4054 15 mg (Drug)
ZD4054 22.5 mg
Experimental
2 x 10 mg + 1 x 2.5 mg oral tablets once daily
干预措施: ZD4054 22.5 mg (Drug)
结局指标
主要结局
Dose Limiting Toxicities (DLTs)
时间窗: Baseline to Day 29.
DLT is defined as experiencing Common Toxicity Criteria (CTC) grade 3 or 4 headache with onset within 24 h of receiving ZD4054, CTC grade 2 rhinitis leading to the withdrawal of the subject, or other CTC grade 3 or 4 toxicity that was considered to be related to ZD4054 treatment. The numbers of patients with a DLT are reported.
次要结局
- Total Prostate Specific Antigen (PSA) Concentration(Baseline to Day 15.)
- Change in Total Prostate Specific Antigen (PSA)(Baseline to Day 15.)
- Change in Serum Concentration of Bone Alkaline Phosphatase (ALP)(Baseline to Day 15.)
- Change in Serum Concentration of Procollagen Type I N Propeptide (PINP)(Baseline to Day 15.)
- Change in Serum Concentration of C-Terminal Telopeptide of Type I Collagen (CTx)(Baseline to Day 15.)
- Change in Urine Concentration of Type I Collagen-Cross Linked N Telopeptide (NTx)(Baseline to Day 15.)
研究者
研究点 (1)
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