EUCTR2008-001395-74-EE进行中（未招募）不适用
A multi-center Phase II study to compare MER-101 20mg tablets to intravenous Zometa® 4mg in male bisphosphonate-naïve, hormone-refractory prostate cancer patients
Merrion Pharmaceuticals plc0 个研究点目标入组 30 人开始时间: 2008年5月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1/. Ability to provide informed consent.
- •2/. Hormone refractory status as evidenced by history of rising PSA levels - last 2 of 3 PSA levels must be above nadir.
- •3/. No prior bisphosphonate treatment.
- •4/. Radiographically-confirmed bone metastases.
- •5/. 18 years of age or older.
- •6/. ECOG of 2 or less within the last 30 days prior to randomization (Appendix I).
- •7/. Adequate organ function defined as:
- •Creatinine clearance of = 60mL/min (as calculated from serum creatinine via the Cockraft-Gault formula).
- •Albumin-adjusted serum calcium =8.0 mg/dL and =11.5 mg/dL.
- •8/. No reported dental problems within 6 months of randomization.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1/. Active dental or jaw condition that requires dental surgery.
- •2/. History of osteonecrosis / osteomyelitis of the jaw or delayed healing after dental surgery.
- •3/. Planned dental surgery within 3 months.
- •4/. Planned surgery or radiation to bone within 3 months.
- •5/. AST/ALT >3x the ULN.
- •6/. Known allergy or hypersensitivity to zoledronic acid.
- •7/. History of alcohol or other substance abuse within the year immediately prior to anticipated study entry.
- •8/. Use of an investigational drug in the past 30 days prior to randomization.
- •9/. Life expectancy < 6 months.
研究者
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