jRCT2051210165暂停不适用
A double-blind, placebo-controlled, randomized, dose-escalating, multicenter, Phase 1 study to assess the safety and tolerability of ART-123 in combination with leucovorin/5-fluorouracil/oxaliplatin and bevacizumab in metastatic colorectal cancer patients
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 80
- 主要终点
- Bleeding eventsDLTs
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •18 years of age or older
- •Metastatic colorectal cancer; pathologically confirmed adenocarcinoma of the colon or rectum
- •ECOG performance status of 0 or 1
- •The most recent laboratory findings (including for liver and kidney) within 14 days prior to randomization remain within acceptable ranges Willingness of the patient and the sexual partner to use a highly effective
- •contraceptive method during the course of the study
- •Able to sufficiently understand the clinical study and give written informed consent
排除标准
- •History of major hemorrhage
- •High risk of hemorrhage
- •History of other malignancies
- •Active ulcer
- •Patients using anti-coagulants and fibrinolytic drugs
- •Active Hepatitis B, or known HBs antigen positive
- •Prior treatment history with thrombomodulin alfa
- •Administration of another investigational medicinal product within 30 days prior to randomization
- •Patient is pregnant (positive urine human chorionic gonadotropin) or breastfeeding or intends to get pregnant during the Treatment period
- •Patients otherwise deemed as inappropriate to participate in the study by the Investigator
结局指标
主要结局
Bleeding eventsDLTs
Bleeding events and Dose Limiting Toxicities
AEs
Adverse Events
Laboratory tests
Laboratory tests
Vital signs
Body temperature, systolic blood pressure, diastolic blood pressure, heart rate
Anti-ART-123 antibodies and neutralizing antibodies
Anti-ART-123 antibodies and neutralizing antibodies
Plasma concentration of thrombomodulin
Plasma concentration of thrombomodulin
Plasma concentration of 5-FU
Plasma concentration of 5-FU
Plasma concentration of oxaliplatin
Plasma concentration of oxaliplatin
Serum concentration of bevacizumab
Serum concentration of bevacizumab
次要结局
未报告次要终点
研究者
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