NCT00558272已完成2 期
A Phase II, Randomised, Open-Label, Pilot Study to Evaluate the Safety and Effects on Bone Resorption of AZD0530 in Patients With Prostate Cancer or Breast Cancer With Metastatic Bone Disease.
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
- 139
- 试验地点
- 1
- 主要终点
- Percentage Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4
研究概览
简要总结
The purpose of this study is to determine the effect of AZD0530 on subjects with breast cancer or prostate cancer with metastatic bone disease in comparison to zoledronic acid.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18 years or older with Prostate Cancer or Breast Cancer with Metastatic Bone Disease Have evidence of recurrence or disease progression
- •At least one radiographically confirmed metastatic bone lesion
- •No change of cancer therapy for at least 8 weeks before randomization
排除标准
- •Have had any prior exposure to bisphosphonate
- •Have had hip fractures or bilateral hip prothesis fracture of any kind or surgery to bone within the past 12 months
- •Inadequate renal function or low haemoglobin
- •Inadequate liver function as demonstrated by serum bilirubin ≥2 times the upper limits of reference range (ULRR) or by alanine aminotransferase (ALT), aspartate aminotransferase(AST) or ALP ≥2.5 times the ULRR (≥5 times the ULRR in the presence of liver metastases). If bone metastases are present and liver function is otherwise considered adequate by the investigator then elevated ALP will not exclude the patient.
研究组 & 干预措施
AZD0530 175 mg
Experimental
AZD0530 (saracatinib) 175 mg once daily
干预措施: AZD0530 (Drug)
Zoledronic Acid 4 mg
Experimental
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
干预措施: Zoledronic Acid (Drug)
结局指标
主要结局
Percentage Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4
时间窗: Baseline to Week 4
Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.
次要结局
- Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase (bALP) at Week 4(Baseline to Week 4)
- Percentage Change From Baseline in Serum Cross-linked C-terminal Telopeptide of Type I Collagen (ICTP) at Week 4(Baseline to Week 4)
- Percentage Change From Baseline in Serum N-terminal Propeptide of Type I Procollagen (PINP) at Week 4(Baseline to Week 4)
- Percentage Change From Baseline in Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) at Week 4(Baseline to Week 4)
- Percentage Change From Baseline in Urine N-terminal Cross-linking Telopeptide of Type I Collagen Normalised to Creatinine (NTx/Cr) at Week 4(Baseline to Week 4)
- Percentage Change From Baseline in Urine Alpha-alpha C-terminal Cross-linking Telopeptide of Type I Collagen Normalised to Creatinine (aaCTx/Cr) at Week 4(Baseline to Week 4)
- Saracatinib: Area Under the Curve at Steady State (AUCss)(Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29)
- Saracatinib: Plasma Clearance at Steady State (CLss/F)(Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29)
- Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max)(Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29)
- Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min)(Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29)
- Saracatinib: Time to Cssmax (Tmax)(Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29)
- N-desmethyl Metabolite of Saracatinib: Area Under the Curve at Steady State (AUCss)(Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29)
- N-desmethyl Metabolite of Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max)(Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29)
- N-desmethyl Metabolite of Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min)(Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29)
- N-desmethyl Metabolite of Saracatinib: AUCss Metabolite to Parent Ratio(Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29)
- N-desmethyl Metabolite of Saracatinib: Time to Cssmax (Tmax)(Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29)
研究者
研究点 (1)
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