A Phase I, Open Label, Non Randomized, Multicenter, Dose Escalation Clinical Study to Investigate Safety and Tolerability of OPB 111077 in Subjects with Advanced Hepatocellular Carcinoma (HCC)

Korea Otsuka Pharmaceuticals0 个研究点目标入组 48 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•1. Histopathologically or clinically diagnosed HCC by Korean Liver Cancer Study Group (KLCSG) guidelines.
•2. Subject who has advanced HCC
•3. Documented evidence of unresponsiveness to, intolerance to, or ineligibility for sorafenib, or unavailability of appropriate sorafenib treatment
•4. Male or female subject, age at consent =20 years and =75 years.
•5. Life expectancy =12 weeks.
•6. Subjects who agree that they or their partner(s) will practice contraception during the study period and 3 months (12 weeks) after the completion of study treatment.
•7. Subjects informed of the diagnosis of advanced HCC who are fully informed about the content of the study by the Investigator or Sub-investigator using the written consent form, and give written consent to participate in the study of their own free will.

•1. Past liver transplantation
•2. Uncontrollable hepatic encephalopathy or ascites
•3. Presence of brain metastases
•4. Clinically significant gastrointestinal bleeding in past 6 months or current active gastrointestinal bleeding.
•5. Primary malignancy other than HCC
•6. Human immunodeficiency virus (HIV) infection
•7. Severe or poorly controlled complication that may affect the conduct or results of the study.
•8. Use of Interferon preparation within 4 weeks (28 days) before start of study treatment in the present study.
•9. Pregnant, nursing, or possibly pregnant women, or women desiring to become pregnant during the study period
•10. Other cases judged by the Investigator or Subinvestigator to be ineligible for participation in the study.

发起方

Korea Otsuka Pharmaceuticals