A Phase I-II Study of BIBF 1120 and FOLFOX Compared to Bevacizumab and FOLFOX in First Line Metastatic Colorectal Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 47
- 主要终点
- Progression-free Survival Rate at 9 Months (PFS-9)
研究概览
简要总结
The primary objective of this study is to evaluate PFS rate at 9 months of BIBF 1120 in combination with mFolfox6 compared with mFolfox6 combined to bevacizumab in first line patients with metastatic colorectal cancer.
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
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BIBF 1120 + mFolfox6
BIBF1120 medium dose twice daily
干预措施: BIBF 1120 (Drug)
BIBF 1120 + mFolfox6
BIBF1120 medium dose twice daily
干预措施: mFolfox 6 (Drug)
BIBF 1120 + mFolfox6
BIBF1120 medium dose twice daily
干预措施: bevacizumab (Drug)
Bevacizumab + mFolfox6
Bevacizumab 5mg/kg once daily every other week
干预措施: BIBF 1120 (Drug)
Bevacizumab + mFolfox6
Bevacizumab 5mg/kg once daily every other week
干预措施: mFolfox (Drug)
Bevacizumab + mFolfox6
Bevacizumab 5mg/kg once daily every other week
干预措施: bevacizumab (Drug)
结局指标
主要结局
Progression-free Survival Rate at 9 Months (PFS-9)
时间窗: First treatment administration to nine months
PFS-9 is defined as the time from first treatment with the trial drug until either the onset of progressive disease or death. A patient is defined as progression-free for 9 months if their PFS was at least 270 days. Progression is assessed according to following mentioned RECIST criteria (version 1.0). 1. 20% increase in the sum of the longest diameter of target lesions. 2. The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
次要结局
- Overall Survival(First treatment administration until end of treatment, up to 892 days)
- Progression-free Survival (PFS)(First treatment administration until end of treatment, up to 892 days)
- Confirmed Objective Response Rate(First treatment administration until end of treatment, up to 892 days)
- Unconfirmed Objective Response Rate(First treatment administration until end of treatment, up to 892 days)
- Resection Rate(First treatment administration until end of treatment, up to 892 days)
- Tumor Shrinkage(Baseline and day 85)
- Incidence and Intensity of Adverse Events With Grading According CTCAE(From the first dose of study medication up to 28 days after the day of the last intake of study medication, up to 920 days)
- Percentage of Patients With Dose Limit Toxicity (DLTs) Incidence During the First Two Treatment Cycles (Phase I).(First two treatment cycles, up to 28 days)
- Maximum Tolerable Dose (MTD)(First two treatment cycles, up to 28 days)
- Area Under the Plasma Concentration Time-curve Over 12 Hours for Nintedanib in the Dosing Interval at Steady State and Normalized by the Dosing Unit Administered (AUCtau,ss,Norm) (Phase I)(-0:05h before drug administration and 1h, 2h, 2.5h, 3h, 4h, 6h, 8h and 10h after drug administration.)
- Maximum Plasma Concentration for Nintedanib at Steady State and Normalized by the Dosing Unit Administered (Cmax,ss,Norm) (Phase I)(-0:05h before drug administration and 1h, 2h, 2.5h, 3h, 4h, 6h, 8h, and 10h after drug administration.)
- Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-C30 for the Change From Baseline at 9 Months of Global Health Status Scores.(Baseline and 9 months.)
- Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-CR38 for the Change From Baseline at 9 Months.(Baseline and 9 months.)
- Number of Participants for Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-CR38 for the First Use of Stoma Bag.(from baseline until end of treatment, up to 892 days)
- Exploratory Biomarker and Pharmacogenetic Analysis for VEGF(Day 1, Day 29, Day 57, Day 85 and Day 127)