NCT00755885已完成1 期
A Cancer Research UK Phase I/II Open Label Study to Evaluate the Safety, Endocrine Effects and Anti-tumour Activity of Abiraterone Acetate (CB7630) in Patients With Oestrogen (ER) or Androgen Receptor (AR) Positive Advanced or Metastatic Breast Carcinoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 12
- 主要终点
- Maximum tolerated dose (MTD) of abiraterone acetate (Phase I)
研究概览
简要总结
RATIONALE: Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of abiraterone acetate and to see how well it works in treating postmenopausal women with advanced or metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate the safety and tolerability of abiraterone acetate in postmenopausal women with estrogen receptor- or androgen receptor-positive advanced or metastatic breast cancer. (Phase I)
- To determine the recommended phase II dose of this drug in these patients. (Phase I)
- To evaluate the clinical benefit rate of this drug at 24 weeks in these patients. (Phase II)
Secondary
- To study the pharmacokinetics of this drug in these patients. (Phase I)
- To determine the endocrine impact of this drug on the pituitary-adrenal-gonad endocrine axis. (Phase I)
- To estimate the duration of objective tumor response in these patients. (Phase II)
- To correlate response rates and duration of response with the endocrine profile in these patients. (Phase II)
- To determine overall survival of these patients. (Phase II)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose (MTD) of abiraterone acetate (Phase I)
Causality of each adverse event and grading severity as measured by NCI CTCAE v3.0 (Phase I)
Proportion of patients with stable disease for ≥ 24 weeks or objective response as measured by RECIST criteria (Phase II)
次要结局
- Plasma levels of abiraterone acetate as measured by liquid chromatography/tandem mass spectrometry assay (Phase I)
- Relationship between dose and endocrine response (Phase I)
- Duration of objective tumor response as measured by RECIST criteria (Phase II)
- Relationship between tumor response and endocrine response (Phase II)
- Median overall survival (Phase II)
研究者
研究点 (12)
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