NCT00172016已完成4 期
A Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 43
研究概览
简要总结
The purpose of this study is to assess the efficacy and tolerability of zoledronic acid in preventing skeletal-related events in patients with prostate cancer
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained
- •Age > 18 years
- •Histologically confirmed diagnosis of carcinoma of the prostate
- •Current (or previous) objective evidence of metastatic disease to the bone
- •Currently receiving 1st line hormonal therapy with LHRH agonists or other hormonal treatments
- •ECOG performance status of 0, 1, or 2
排除标准
- •Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal or by a calculated creatinine clearance of 60 ml/minute or less
- •Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L)
- •WBC<3.0x1'000'000'000, ANC < 1500/mm3, Hgb<8.0 g/dL, platelets < 75 x 1'000'000'000/L.
- •Liver function tests >2.5 ULN, serum creatinine >1.5 ULN.
- •Patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol.
- •Known hypersensitivity to zoledronic acid or other bisphosphonates
- •Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study
- •Other protocol-defined inclusion / exclusion criteria apply.
研究组 & 干预措施
ZOL446 (zoledronic acid)
Experimental
干预措施: Zoledronic acid (Drug)
研究者
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