A Phase I/II Study of Continuous, Concomitant Oral Treatment With BIBF 1120 and Pemetrexed - a Phase I, Open-label, Dose-escalation Study & a Phase II, 2 Arm, Randomized, Double-blind, Placebo-controlled Study in Japanese Patients With Stage IIIB/IV or Recurrent Non-small-cell Lung Cancer After Failure of Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 3
- 主要终点
- Dose Limiting Toxicities
研究概览
简要总结
The objectives of this trial are to estimate the following in Japanese patients with advanced NSCLC of stage IIIB/IV or with recurrence after failure of first-line chemotherapy.
Phase I part The objective of the phase I part is to define the Maximum Tolerated Dose (MTD) of BIBF 1120 at a dose level up to twice daily 200 mg with standard dose of pemetrexed (500 mg/m^2) and to determine the Recommended Dose (RD) for the phase II part.
Phase II, to investigate the efficacy and safety of BIBF 1120 in combination with pemetrexed (500 mg/m^2) as compared to pemetrexed (500 mg/m^2) + placebo
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
- Double
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BIBF 1120 BID + Pemetrexed
Phase I part: Find MTD by using low, medium or high BIBF 1120 twice daily and 500mg/m^2 pemetrexed once every 3 weeks
干预措施: BIBF 1120 M + Pemetrexed (Drug)
BIBF 1120 BID + Pemetrexed
Phase I part: Find MTD by using low, medium or high BIBF 1120 twice daily and 500mg/m^2 pemetrexed once every 3 weeks
干预措施: BIBF 1120 H + Pemetrexed (Drug)
BIBF 1120 BID + Pemetrexed
Phase I part: Find MTD by using low, medium or high BIBF 1120 twice daily and 500mg/m^2 pemetrexed once every 3 weeks
干预措施: BIBF 1120 L + Pemetrexed (Drug)
BIBF 1120 BID (RD) + Pemetrexed
PHase II part: Study arm
干预措施: BIBF 1120 RD + Pemetrexed (Drug)
BIBF 1120 BID(Placebo) + Pemetrexed
Phase II part: Comparator arm
干预措施: BIBF 1120 Placebo + Pemetrexed (Drug)
结局指标
主要结局
Dose Limiting Toxicities
时间窗: During the first course, 21 days
Number of participants with dose limiting toxicity (DLT) in combination therapy of BIBF 1120 and pemetrexed during the first course
Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses
时间窗: Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days
Number of patients with adverse events according to worst Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses. CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE) or 5 (death related to AE).
次要结局
- Disease Control Rate(Every 6 weeks after start of study treatment until end of treatment, up to 992 days)
- Overall Response Rate(Every 6 weeks after start of study treatment until end of treatment, up to 992 days)
- Duration of Disease Control(From first study drug administration until PD or death, up to 1003 days)
- Number of Participants With Clinically Relevant Abnormalities in Laboratory Parameters(Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days)
- AUC0-inf of Nintedanib(5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1)
- Cmax of Nintedanib(5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1)
- AUC0-inf of Pemetrexed(5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2)
- Cmax of Pemetrexed(5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2)