Phase Ib / II Study of BAY 1000394 in Combination With Cisplatin / Etoposide or Carboplatin / Etoposide as First-line Therapy in Subjects With Extensive Disease Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 43
- 主要终点
- Area under the concentration versus time curve from zero to infinity after single (first) dose(AUC) of BAY1000394
研究概览
简要总结
This is the first study where BAY1000394 is given in combination with chemotherapy: cisplatin / etoposide or carboplatin / etoposide. Patients with small cell lung cancer will be treated. Every patient will receive drug treatment, there is no placebo group. Different groups of patients will receive different dosages of BAY1000394 to determine the safety and maximum tolerated dose (MTD) of BAY1000394 in combination with chemotherapy. The dose of chemotherapy is the standard dose usually administered and will not change.
The study will also assess how the drug is metabolized by the body and changes in tumor size.
BAY1000394 will be given per mouth, twice a day for three days every week. Treatment will stop if the tumor continues to grow, if side effects occur which the patient can not tolerate or if the patients decides to exit treatment.
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
- •Male or female subjects aged >/=18 years
- •Histologically or cytologically confirmed, extensive disease SCLC
- •At least 1 solid tumor lesion measurable by computer tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST 1.
- •Subjects with non-measurable disease according to RECIST 1.1 can be included in the Phase Ib part of the study
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
- •Life expectancy of at least 12 weeks
- •Serum sodium >/=130 mmol/L
排除标准
- •Prior systemic anticancer therapy
- •Prior radiotherapy (local palliative radiotherapy is permitted)
- •History of cardiac disease: congestive heart failure > NYHA Class II, unstable angina (anginal symptoms at rest), any episodes of angina or history of myocardial infarction, cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted), previous venous or arterial thrombotic events, pulmonary embolism
- •Moderate or severe hepatic impairment, ie Child-Pugh class B or C
- •Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
研究组 & 干预措施
Arm 1
BAY1000394 will be administered in combination with chemotherapy (etoposide and cisplatin or carboplatin) for up to 6 cycles. BAY1000394 will continue beyond Cycle 6 of chemotherapy. Type of chemotherapy for each patient will be decided by the investigator case by case.
干预措施: Roniciclib (BAY1000394) (Drug)
Arm 1
BAY1000394 will be administered in combination with chemotherapy (etoposide and cisplatin or carboplatin) for up to 6 cycles. BAY1000394 will continue beyond Cycle 6 of chemotherapy. Type of chemotherapy for each patient will be decided by the investigator case by case.
干预措施: Etoposide (Drug)
Arm 1
BAY1000394 will be administered in combination with chemotherapy (etoposide and cisplatin or carboplatin) for up to 6 cycles. BAY1000394 will continue beyond Cycle 6 of chemotherapy. Type of chemotherapy for each patient will be decided by the investigator case by case.
干预措施: Cisplatin (Drug)
Arm 1
BAY1000394 will be administered in combination with chemotherapy (etoposide and cisplatin or carboplatin) for up to 6 cycles. BAY1000394 will continue beyond Cycle 6 of chemotherapy. Type of chemotherapy for each patient will be decided by the investigator case by case.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Area under the concentration versus time curve from zero to infinity after single (first) dose(AUC) of BAY1000394
时间窗: Cycle 1, Day 8 and Cycle 2, Day 1
Safety variables will be summarized using descriptive statistics based on adverse events collection
时间窗: up to 3 years
tumor response - number of subjects with best tumor response that is achieved during or within 30 days after end of therapy
时间窗: up to 3 years
Maximum drug concentration in plasma after single dose administration(Cmax) of BAY1000394
时间窗: Cycle 1, Day 8 and Cycle 2, Day 1
Maximum Tolerated Dose (MTD) - measured by adverse event profile at the end of Cycle 1. MTD will be the highest dose level achieved during dose escalation where non or 1 of 6 subjects experience a dose limiting toxicity as defined in the protocol
时间窗: up to 3 years
次要结局
- Overall survival (OS)(From start of treatment of the first subject until 3 years later)
- Disease control rate (DCR)(From start of treatment of the first subject until 3 years later, assessed every 6 weeks)
- Time to progression (TTP)(From start of treatment of the first subject until 3 years later, assessed every 6 weeks)
- Progression-free survival (PFS)(From start of treatment of the first subject until 3 years later, assessed every 6 weeks)
- Duration of response (DOR)(From start of treatment of the first subject until 3 years later, assessed every 6 weeks)
- Stable disease (SD)(From start of treatment of the first subject until 3 years later, assessed every 6 weeks)