NCT00516438已完成1 期
A Phase I, Open-Label, Study of the Safety and Tolerability of KU-0059436 and Topotecan in the Treatment of Patients With Advanced Solid Tumours
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with topotecan
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 topotecan chemotherapy in patients with advanced solid tumours
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of advanced solid tumour for which no suitable effective therapy exists;
- •Evaluable disease
- •Adequate bone marrow, hepatic and renal function
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
- •Heavily pre treated patient > 2 previous chemotherapy regimens for metastatic disease
- •Co-existing active infection
研究组 & 干预措施
1
Experimental
Topotecan + KU-0059436
干预措施: KU-0059436 (AZD2281)(PARP inhibitor) (Drug)
1
Experimental
Topotecan + KU-0059436
干预措施: Topotecan (Drug)
结局指标
主要结局
To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with topotecan
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)
Loading locations...
相似试验
已完成
1 期
Study to Assess the Safety & Tolerability of a PARP Inhibitor in Combination With Gemcitabine in Pancreatic CancerPancreatic NeoplasmsNCT00515866AstraZeneca68
已完成
1 期
Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or PaclitaxelTriple Negative Metastatic Breast CancerAdvanced Ovarian CancerCarboplatinPaclitaxelNCT00516724AstraZeneca189
已完成
1 期
A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of PARP in Combination With DacarbazineMelanoma NeoplasmsNCT00516802AstraZeneca40
已完成
1 期
Phase 1 Safety and Tolerability of MEDI4736 in Combination With Dabrafenib and Trametinib or With Trametinib AloneMelanomaNCT02027961MedImmune LLC68
进行中（未招募）
1 期
A Study to Learn About the ARV-471 (PF-07850327) in People With ER+/HER2- Locally Advanced or Metastatic Breast Cancer (BC)Breast NeoplasmsNCT05463952Pfizer6