NCT00516724已完成1 期
A Phase I, Open-Label Study to Assess the Safety and Tolerability of KU-0059436 in Combination With Carboplatin, KU-0059436 in Combination With a Paclitaxel/Carboplatin T/C Doublet and KU-0059436 in Combination With Paclitaxel in the Treatment of Patients With Advanced Solid Tumours
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with Paclitaxel/Carboplatin
研究概览
简要总结
The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with carboplatin and/or Paclitaxel chemotherapy.
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
- •Male or female patients with a histologically or cytologically diagnosed malignant solid tumour
- •Adequate bone marrow, hepatic and renal function
- •Performance status of no more than 2 ( ECOG scale).
排除标准
- •Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry
- •Major surgery with 4 weeks of entering the study and must have recovered from effects of the major surgery
- •More than two previous courses of platinum-containing chemotherapy
- •Heavily pre-treated patients(> 2 courses of previous chemotherapy and/or extensive irradiation leading to bone marrow deficiency) will be excluded from the study
研究组 & 干预措施
1
Experimental
Carboplatin + KU-0059436
干预措施: KU-0059436 (AZD2281)(PARP inhibitor) (Drug)
1
Experimental
Carboplatin + KU-0059436
干预措施: Carboplatin (Drug)
2.
Experimental
Paclitaxel + KU-0059436
干预措施: KU-0059436 (AZD2281)(PARP inhibitor) (Drug)
2.
Experimental
Paclitaxel + KU-0059436
干预措施: Paclitaxel (Drug)
3.
Experimental
Paclitaxel, Carboplatin + KU-0059436
干预措施: KU-0059436 (AZD2281)(PARP inhibitor) (Drug)
3.
Experimental
Paclitaxel, Carboplatin + KU-0059436
干预措施: Paclitaxel + Carboplatin (Drug)
结局指标
主要结局
To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with Paclitaxel/Carboplatin
时间窗: assessed at each visit
次要结局
- To identify the dose limiting toxicity of the combination therapy(assessed at each visit)
研究者
研究点 (1)
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