An Open-label, Dose Escalation Phase I Study of the Safety and Tolerability of BIBF 1120 in Combination With Carboplatin and Pegylated Liposomal Doxorubicin (PLD) in Japanese Patients With a First, Second or Third Platinum-sensitive Relapse of Advanced Epithelial Ovarian Cancer, Fallopian Tube or Primary Peritoneal Cancer.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 3
- 主要终点
- Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) of Nintedanib
研究概览
简要总结
This phase I, open label dose escalation study will investigate the addition of BIBF 1120 to treatment with the combination of carboplatin and Pegylated Liposomal Doxorubicin (PLD) in patients with advanced, platinum sensitive relapsed ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer. Patients will be treated with BIBF 1120 together with carboplatin and PLD in up to 6-9 repeated 28 days treatment courses until disease progression is observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 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 (low) + Carboplatin + PLD
BIBF 1120 (low dose) + carboplatin (AUC5 mg/mL*min) + PLD (30 mg/m2)
干预措施: BIBF 1120 (low) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min (Drug)
BIBF 1120 (medium) + Carboplatin + PLD
BIBF 1120 (medium dose) + carboplatin (AUC5 mg/mL*min) + PLD (30 mg/m2)
干预措施: BIBF 1120 (medium) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min (Drug)
BIBF 1120 (high) + Carboplatin + PLD
BIBF 1120 (high dose) + carboplatin (AUC5 mg/mL*min) + PLD (30 mg/m2)
干预措施: BIBF 1120 (high) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min (Drug)
结局指标
主要结局
Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) of Nintedanib
时间窗: 28 days
to determine the MTD of nintedanib in combination with carboplatin (AUC 5 mg/mL·min) and PLD (30 mg/m2) reflected by the number of DLTs per dose level. This endpoint has not been statistically analyzed in the study report.
次要结局
- Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity (AUC0-∞)(0.5h after the start of the infusion up to 56 days)
- Maximum Measured Plasma Concentration (Cmax)(0.5h after the start of the infusion up to 56 days)
- Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz)(0.5h after the start of the infusion up to 56 days)
- Time From Dosing to the Maximum Plasma Concentration (Tmax)(0.5h after the start of the infusion up to 56 days)
- Terminal Half-life (t1/2)(0.5h after the start of the infusion up to 56 days)
- Total Plasma Clearance (CL)(0.5h after the start of the infusion up to 56 days)
- Apparent Volume of Distribution at Steady State (Vss)(0.5h after the start of the infusion up to 56 days)