NCT00631410已完成1 期
Phase I Study Of Sunitinib In Combination With Oxaliplatin, L-Leucovorin, And 5-Fluorouracil In Patients With Metastatic Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
To assess the safety and tolerability of sunitinib when administered in combination with modified FOLFOX6 in Japanese patients with metastatic colorectal cancer in the first-line treatment setting.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed adenocarcinoma of the colon or rectum with documented locally advanced or metastatic disease.
- •Evidence of unidimensionally measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
排除标准
- •Prior treatment with systemic therapy for locally advanced or metastatic colorectal cancer.
- •Prior surgery or investigational agent within 4 weeks prior to study entry.
- •Pregnancy or breastfeeding. All female patients of reproductive potential must have a negative pregnancy test (serum or urine) prior to the start of the study.
研究组 & 干预措施
A
Experimental
干预措施: sunitinib + mFOLFOX6 (Drug)
B
Experimental
干预措施: sunitinib + mFOLFOX6 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Up to 733 days (the last subject study discontinuation)
Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , serious adverse events, adverse events resulted in discontinuation, treatment interruption, or dose reduction.
次要结局
- Progression-Free Survival (PFS)(Up to 733 days (the last subject study discontinuation))
- Sunitinib Relative Dose Intensity in the Treatment Arm A(Up to 733 days (the last subject study discontinuation in the Treatment Arm A))
- Sunitinib Relative Dose Intensity in the Treatment Arm B(Up to 384 days (the last subject study discontinuation in the Treatment Arm B))
- Plasma Concentration of Sunitinib(Cycle 1 Day 14 and Cycle 2 Day 1)
- Plasma Concentration of Sunitinib Active Metabolite (SU012662)(Cycle 1 Day 14 and Cycle 2 Day 1)
- Plasma Concentration of the Total Drug (Sunitinib Plus SU012662)(Cycle 1 Day 14 and Cycle 2 Day 1)
- Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)(Up to the last subject completed Cycle 24 or individual study discontinuation)
- Duration of Response (DR)(Up to 733 days (the last subject study discontinuation))
研究者
研究点 (1)
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