临床试验/JPRN-UMIN000013006

JPRN-UMIN000013006已完成1 期

Phase I study of cetuximab plus U3-1565 in colorectal cancer with resistance to anti-EGFR antibody - U3-1565-CRC P-I

St. Marianna University School of Medicine Hospital0 个研究点目标入组 22 人开始时间: 2014年3月1日最近更新: 2023年10月17日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: St. Marianna University School of Medicine Hospital
入组人数: 22

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

o dose-limiting toxicities were observed among three patients in level 1 in the first stage, which was determined as RD.

研究设计

研究类型: Interventional

入排标准

年龄范围: 20years-old 至 ot applicable（—）
性别: All

入选标准

未提供

排除标准

•1) Any chemotherapy within 2 weeks prior to enrollment 2) Any surgery or radiation within 4 weeks prior to enrollment 3) Any investigatilnal drug within 4 weeks prior to enrollment 4) Previous administration of U3-1565 5) Hypersensitivity to U3-1565 or its additives 6) Metastasis to central nervous system 7) Pleural effusion, ascites or pericardial effusion under drainage 8) Other currently active malignancies excluding malignancies that are disease free for more than 3 years or carcinoma-in -situ deemed cured by adequate treatment 9) History of any severe medical condition 10) HBs Ag: positive, HCV Ab: positive 11) Continuous systemic steroids or immunosuppressant drug 12) Active bleeding 13) No contraception 14) No will or impossible to follow the protocol 15) Investigator considered the patients inappropriate to the trial.

研究者

发起方

St. Marianna University School of Medicine Hospital

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Phase I study of cetuximab plus U3-1565 in... | 临床试验