Phase I/II Study to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of ZK 219477 in Combination With Cisplatin as First-line Therapy in Chemotherapy-naïve Patients With Extensive-disease (ED) Stage Small-cell Lung Cancer (SCLC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 26
- 主要终点
- Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with cisplatin
研究概览
简要总结
The purpose of the study is to determine whether the study drug ZK 219477 (also known as SH Y03757A) combined with cisplatin, is effective in the treatment of small cell lung cancer in patients who did not receive prior treatment for their lung cancer
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Small-cell lung cancer
- •Stage of extensive disease
- •Adequate function of major organs and systems
- •Use of highly effective birth control methods in females of child-bearing potential
排除标准
- •Prior chemotherapy for small-cell lung cancer
- •Prior surgical resection or radiotherapy for SCLC within at least 3 to 4 weeks prior to inclusion and with the exception of radiation of brain metastases
- •Superior vena cava syndrome or obstruction of any vital structure
- •Untreated malignant hypercalcemia; Extensive disease amenable to radiation therapy; Symptomatic brain metastases requiring whole-brain irradiation
- •Known allergy or hypersensitivity to platinum-containing drugs
- •Pregnancy or breast-feeding
- •Use of any investigational drug within 4 weeks before start of the study
研究组 & 干预措施
Sagopilone and cisplatin
The study drug sagopilone was administered in combination with a fixed dose of cisplatin
干预措施: Sagopilone (BAY86-5302, ZK 219477) (Drug)
Sagopilone and cisplatin
The study drug sagopilone was administered in combination with a fixed dose of cisplatin
干预措施: Cisplatin (Drug)
结局指标
主要结局
Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with cisplatin
时间窗: Phase 1: Baseline up to 3 month of treatment
Phase 2: Efficacy measure
时间窗: Phase 2: every 6 weeks after start of treatment
次要结局
- Phase 2: PFS(every 6 weeks after start of treatment)
- Phase 2: TTP(every 6 weeks after start of treatment)
- Phase 1: PK of Sagopilone + Cisplatin(Upto 336 h after the beginning of the sagopilone infusion and upto 20 h 45 min after the beginning of the cisplatin infusion)
- Phase 2: OS(every 3 months after start of treatment)
- Phase 2: Duration of CR or PR(every 6 weeks after start of treatment)