NCT00819221终止1 期
A Phase I, Open Label, Multicenter Study to Assess the Safety, Tolerability and Pharmacology of AZD2281 in Combination With Liposomal Doxorubicin (Caelyx®) in Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- recommended dose
研究概览
简要总结
The study will be an open label, multicenter, dose finding study. Depending on the tolerated dose up to 7 dose levels will be explored in this study, approximately 33 patients (21-54 depending on number of cohorts) may be enrolled into this study. Three patients will be initially dosed in each cohort. The primary objective of this study is to determine the recommended dose (RD) of twice daily oral doses of AZD2281 either as intermittent therapy for 7 days out of a 28-day schedule or given continuously, administered in combination with liposomal doxorubicin to patients with advanced solid tumors.
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 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent
- •Measurable or evaluable disease
- •ECOG Performance status 0 - 2
- •Estimated life expectancy of at least 12 weeks
排除标准
- •More than 3 prior lines of chemotherapy for advanced disease
- •Less than 28 days from active treatment (ie, any treatment used to treat the disease) or high dose radiotherapy (patients may continue concomitant use of stable dose of bisphosphonates if used at least 28 days prior to commencing study treatment and pat
- •Prior treatment with >300mg/m2 cumulative dose of doxorubicin equivalent
- •Resistance to anthracyclines defined as progressive disease during anthracycline treatment or within 6 months after the last anthracycline administration.
研究组 & 干预措施
1
Experimental
干预措施: AZD2281 (Drug)
1
Experimental
干预措施: liposomal doxorubicin (Drug)
结局指标
主要结局
recommended dose
时间窗: 2 months
次要结局
- DNA repair mechanism(once)
- pharmacokinetics(6 visits within 1 month)
- safety/tolerability/toxicity(2 months)
研究者
研究点 (1)
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