An Open-label, Multiple-site, Phase I/II Dose Cohort Trial of [6R] 5,10-Methylene Tetrahydrofolate (Modufolin®) in Combination With a Fixed Dose of 5-Fluorouracil (5-FU) Alone or Together With a Fixed Dose of Oxaliplatin or Irinotecan in Patients With Stage IV Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 10
- 主要终点
- Frequency and severity of dose limiting toxicity (DLT) or other Adverse Events (AE)
研究概览
简要总结
The purpose is to characterise the tolerability of Modufolin (arfolitixorin) in combination with 5-FU alone, in combination with 5-FU and Oxaliplatin, in combination with 5-FU and Irinotecan and in combination with 5-FU, Oxaliplatin and Bevacizumab.
Another purpose is to investigate 4 doses of Modufolin to identify the best dose for further assessment.
详细描述
The study will investigate the tolerability of Modufolin at four (4) different dose levels (30 to 240 mg/m2) in therapy combinations with the chemotherapeutic agents 5-FU, Oxaliplatin +/- bevcizumab, and Irinotecan.
When the selected phase 2 dose is determined, 40 additional patients, will be included in the study in order to acquire more data on the safety and tolerability of Modufolin at this dose level. Twenty (20) of these additional patients will be treated in with Oxaliplatin, 20 with Irinotecan.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced metastatic colorectal (Stage IV) cancer verified by biopsy
排除标准
- 未提供
研究组 & 干预措施
Modufolin / Nordic FLV
Modufolin in combination with 5-Fluorouracil only.
干预措施: Modufolin (arfolitixorin) (Drug)
Modufolin / Nordic FLV
Modufolin in combination with 5-Fluorouracil only.
干预措施: Fluorouracil (Drug)
Modufolin / Nordic FLOX
Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to Nordic FLOX regime
干预措施: Modufolin (arfolitixorin) (Drug)
Modufolin / Nordic FLOX
Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to Nordic FLOX regime
干预措施: Fluorouracil (Drug)
Modufolin / Nordic FLOX
Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to Nordic FLOX regime
干预措施: Oxaliplatin (Drug)
Modufolin / Nordic FLIRI
Modufolin in combination with 5-Fluorouracil and Irinotecan.
干预措施: Modufolin (arfolitixorin) (Drug)
Modufolin / Nordic FLIRI
Modufolin in combination with 5-Fluorouracil and Irinotecan.
干预措施: Fluorouracil (Drug)
Modufolin / Nordic FLIRI
Modufolin in combination with 5-Fluorouracil and Irinotecan.
干预措施: Irinotecan (Drug)
MOFOX
Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to mFOLFOX-6 regime
干预措施: Modufolin (arfolitixorin) (Drug)
MOFOX
Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to mFOLFOX-6 regime
干预措施: Fluorouracil (Drug)
MOFOX
Modufolin in combination with 5-Fluorouracil and Oxaliplatin according to mFOLFOX-6 regime
干预措施: Oxaliplatin (Drug)
MOFOX / Bevacizumab
Modufolin in combination with 5-Fluorouracil, Oxaliplatin and Bevacizumab
干预措施: Modufolin (arfolitixorin) (Drug)
MOFOX / Bevacizumab
Modufolin in combination with 5-Fluorouracil, Oxaliplatin and Bevacizumab
干预措施: Fluorouracil (Drug)
MOFOX / Bevacizumab
Modufolin in combination with 5-Fluorouracil, Oxaliplatin and Bevacizumab
干预措施: Oxaliplatin (Drug)
MOFOX / Bevacizumab
Modufolin in combination with 5-Fluorouracil, Oxaliplatin and Bevacizumab
干预措施: Bevacizumab (Drug)
MOFIRI
Modufolin in combination with 5-Fluorouracil and Irinotecan
干预措施: Modufolin (arfolitixorin) (Drug)
MOFIRI
Modufolin in combination with 5-Fluorouracil and Irinotecan
干预措施: Fluorouracil (Drug)
MOFIRI
Modufolin in combination with 5-Fluorouracil and Irinotecan
干预措施: Irinotecan (Drug)
结局指标
主要结局
Frequency and severity of dose limiting toxicity (DLT) or other Adverse Events (AE)
时间窗: The patients will be followed during 4 cycles of treatment (8 weeks).
Primary safety variables will consist of monitoring and recording of DLTs and any significant AE that have led to adjustments in the therapy administration.
次要结局
未报告次要终点