A Phase I Study of Continuous, Concomitant Oral Treatment With BIBF 1120 and Docetaxel - a Phase I, Open-label, Dose-escalation 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
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses
研究概览
简要总结
To confirm the safety of BIBF 1120 at a dose level up to 200 mg x 2/day (i.e., overseas recommended Phase III dose for combination treatment) with standard therapy of docetaxel (60 mg/m2 and 75 mg/m2) in Japanese advanced non small cell lung cancer (NSCLC) patients with stage IIIB/IV or recurrent after failure of first line chemotherapy and to determine the recommended dose for the Phase II trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 + docetaxel
Low, medium and high dose of BIBF 1120 and 60 mg/m2, 75 mg/m2 docetaxel every 3 weeks
干预措施: BIBF 1120 M + docetaxel M (Drug)
BIBF 1120 + docetaxel
Low, medium and high dose of BIBF 1120 and 60 mg/m2, 75 mg/m2 docetaxel every 3 weeks
干预措施: BIBF 1120 M + docetaxel H (Drug)
BIBF 1120 + docetaxel
Low, medium and high dose of BIBF 1120 and 60 mg/m2, 75 mg/m2 docetaxel every 3 weeks
干预措施: BIBF 1120 H + docetaxel H (Drug)
BIBF 1120 + docetaxel
Low, medium and high dose of BIBF 1120 and 60 mg/m2, 75 mg/m2 docetaxel every 3 weeks
干预措施: BIBF 1120 L + docetaxel M (Drug)
BIBF 1120 + docetaxel
Low, medium and high dose of BIBF 1120 and 60 mg/m2, 75 mg/m2 docetaxel every 3 weeks
干预措施: BIBF 1120 H + docetaxel M (Drug)
结局指标
主要结局
Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses
时间窗: Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days
Number of participants with adverse events according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).
Number of Participants Who Experienced Dose Limited Toxicity in Combination Therapy of Nintedanib and Docetaxel
时间窗: During the first treatment course, up to 3 weeks
Number of participants experienced Dose Limited Toxicity (DLT) in combination therapy of nintedanib and docetaxel. Maximum tolerated dose (MTD) of nintedanib combination with docetaxel were to be determined separately in the patient groups of body surface area (BSA) \<1.5 m2 and BSA ≥1.5 m2. The MTD were to be determined as a combination of a dose equal to or less than 200 mg b.i.d. of nintedanib and 60 mg/m2 and 75 mg/m2 every 3 weeks of docetaxel at which either 0 out of 3, 1 out of 6, or 2 out of 6 patients experienced DLT.
次要结局
- AUC0-inf of Nintedanib in Course 1(-0:05 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1)
- Objective Tumor Response(Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days))
- Disease Control(Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days))
- Time to Treatment Failure (TTF)(Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days))
- Clinical Relevant Abnormalities in Laboratory Parameters(Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days)
- Cmax of Docetaxel in Course 1(-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration)
- AUC0-inf of Docetaxel in Course 2(-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration)
- Progression-Free Survival (PFS)(Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days))
- Cmax of Nintedanib in Course 1(-0:05h before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1)
- AUC0-inf of Docetaxel in Course 1(-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration)
- Cmax of Docetaxel in Course 2(-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration)