A Phase I, Open-label Study to Assess the Safety and Tolerability of AZD0530 in Combination With Carboplatin and/or Paclitaxel Chemotherapy in Patients With Solid Tumours
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of AZD0530 in combination with carboplatin and/or paclitaxel regimens with solid tumours by assessment of AEs, physical examination, BP, pulse, ECG, laboratory findings, PFTs and thoracic CT scans.
研究概览
简要总结
This study will comprise 2 parts, a dose escalation phase and a dose expansion phase. The 2 phases are part of a single study and described by this single protocol. Patients entered into the dose escalation phase will not be entered into the expansion phase. All subjects must be suitable for treatment with either carboplatin and/or paclitaxel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Life expectancy > 12 weeks
- •Women defined as post-menopausal
- •Male or female patients with locally advanced or metastatic cancer suitable for treatment with carboplatin and/or paclitaxel
排除标准
- •Inadequate bone marrow reserve
- •Inadequate live function, renal function or low haemoglobin
- •Unresolved toxicity from anti-cancer therapy
研究组 & 干预措施
1
AZD0530 + Paclitaxel
干预措施: AZD0530 (Drug)
1
AZD0530 + Paclitaxel
干预措施: Paclitaxel (Drug)
2
AZD0530 + Carboplatin
干预措施: AZD0530 (Drug)
2
AZD0530 + Carboplatin
干预措施: Carboplatin (Drug)
3
AZD0530 + Carboplatin + Paclitaxel
干预措施: AZD0530 (Drug)
3
AZD0530 + Carboplatin + Paclitaxel
干预措施: Carboplatin (Drug)
3
AZD0530 + Carboplatin + Paclitaxel
干预措施: Paclitaxel (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of AZD0530 in combination with carboplatin and/or paclitaxel regimens with solid tumours by assessment of AEs, physical examination, BP, pulse, ECG, laboratory findings, PFTs and thoracic CT scans.
时间窗: Assessed at each visit
次要结局
- To determine the Maximum Tolerated Dose of AZD0530 when administered in combination with carboplatin and/or paclitaxel by assessment of safety and tolerability data generated for each treatment arm.(Assessed at each visit)
- To make a preliminary evaluation of clinical response by assessment of RECIST evaluation, time to progression and serum tumour markers.(Assessment at end of study)
- To investigate the PK of AZD0530. paclitaxel and carboplatin when co-administered to patients with solid tumours, by assessment of appropriate PK parameters.(Predetermined timepoints after dose administration)