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Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease

2013年5月23日 更新者：AstraZeneca

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.

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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

139

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 丹麦
      • Arhus N、丹麦
        • Research Site
      • Frederica、丹麦
        • Research Site
      • Herlev、丹麦
        • Research Site
      • Holstebro、丹麦
        • Research Site
  • 加拿大
      • Quebec、加拿大
        • Research Site
    • Alberta
      • Edmonton、Alberta、加拿大
        • Research Site
    • British Columbia
      • Vancouver、British Columbia、加拿大
        • Research Site
    • Ontario
      • Toronto、Ontario、加拿大
        • Research Site
    • Quebec
      • Montreal、Quebec、加拿大
        • Research Site
  • 挪威
      • Kristiansand、挪威
        • Research Site
      • Oslo、挪威
        • Research Site
  • 瑞典
      • Uppsala、瑞典
        • Research Site
  • 美国
    • California
      • Pleasant Hill、California、美国
        • Research Site
      • Sacramento、California、美国
        • Research Site
    • Connecticut
      • Middlebury、Connecticut、美国
        • Research Site
    • Florida
      • Aventura、Florida、美国
        • Research Site
    • Maryland
      • Baltimore、Maryland、美国
        • Research Site
    • Michigan
      • Ann Arbor、Michigan、美国
        • Research Site
    • New York
      • Poughkeepsie、New York、美国
        • Research Site
    • North Carolina
      • Winston-salem、North Carolina、美国
        • Research Site
    • Pennsylvania
      • Hershey、Pennsylvania、美国
        • Research Site
  • 英国
      • Cardiff、英国
        • Research Site
      • Glasgow、英国
        • Research Site
      • Manchester、英国
        • Research Site
  • 葡萄牙
      • Lisboa、葡萄牙
        • Research Site
  • 西班牙
    • Cataluna
      • Barcelona、Cataluna、西班牙
        • Research Site
      • Lerida、Cataluna、西班牙
        • Research Site
    • Comunidad Valenciana
      • Valencia、Comunidad Valenciana、西班牙
        • Research Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：AZD0530 175 mg
AZD0530 (saracatinib) 175 mg once daily
药品：AZD0530
Daily oral dose
其他名称：
  • 沙拉卡替尼
实验性的：Zoledronic Acid 4 mg
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
药品：唑来膦酸
其他名称：
  • 卓美达

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4
大体时间：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.
Baseline to Week 4

次要结果测量

结果测量
措施说明
大体时间
Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase (bALP) at Week 4
大体时间：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.
Baseline to Week 4
Percentage Change From Baseline in Serum Cross-linked C-terminal Telopeptide of Type I Collagen (ICTP) at Week 4
大体时间：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.
Baseline to Week 4
Percentage Change From Baseline in Serum N-terminal Propeptide of Type I Procollagen (PINP) at Week 4
大体时间：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.
Baseline to Week 4
Percentage Change From Baseline in Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) at Week 4
大体时间：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.
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
大体时间：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.
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
大体时间：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.
Baseline to Week 4
Saracatinib: Area Under the Curve at Steady State (AUCss)
大体时间：Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29
Previous studies have shown that saracatinib reduces osteoclast function and bone resorption. Bone turnover, the combined result of bone formation and bone resorption, can be assessed in real time by measuring specific markers of bone turnover in serum and in urine. These markers were assessed in a study of patients with metastatic bone disease treated with saracatinib. Specific assays are available to quantitate these markers in serum and urine. In this study the effects of saracatinib on bone turnover were compared with the effects of zoledronic acid, a marketed drug known to inhibit bone resorption in cancer patients with bone metastatses.
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)
大体时间：Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29
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)
大体时间：Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29
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)
大体时间：Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29
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)
大体时间：Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29
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)
大体时间：Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29
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)
大体时间：Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29
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)
大体时间：Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29
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
大体时间：Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29
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)
大体时间：Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29
Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AstraZeneca

调查人员

  • 研究主任：Richard Finkelman, DDS, PhD、AstraZeneca
  • 首席研究员：Meabe Aklilu, MD、Wake Forest University Health Sciences

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年2月1日

初级完成 (实际的)

2010年1月1日

研究完成 (实际的)

2012年8月1日

研究注册日期

首次提交

2007年11月13日

首先提交符合 QC 标准的

2007年11月13日

首次发布 (估计)

2007年11月14日

研究记录更新

最后更新发布 (估计)

2013年5月27日

上次提交的符合 QC 标准的更新

2013年5月23日

最后验证

2013年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • D8180C00034

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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