NCT02358395已完成1 期
A Phase I Study of BBI608 Administrated With Sorafenib in Adult Patients With Advanced Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Assessment of dose-limiting toxicities (DLTs).
研究概览
简要总结
This is an open-label, multicenter, phase 1 study of BBI608 in combination with Sorafenib. This study population is adult Japanese patients with advanced hepatocellular carcinoma in Sorafenib combination therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 diagnosed imaging with hepatocellular carcinoma, and not indicated with a)-d) .
- •Radiofrequency ablation therapy (RFA)
- •Local therapy [such as percutaneous transhepatic ethanol injection therapy (PEIT), Microwave coagulation therapy (MCT)]
- •Transcatheter arterial embolization (TAE)
- •Transcatheter arterial chemoembolization (TACE)
- •≥ 20 years of age.
- •Not treatment with systemic chemotherapy.
- •Signed written informed consent must be obtained and documented.
- •Life expectancy ≥ 3 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Must be Child Pugh Class A.
- •Hemoglobin ≥ 8.5 mg/dl.
- •Absolute neutrophil count ≥ 1.5 x 10^9 /L.
- •Platelets ≥ 75 x 10^9/L.
- •Creatinine ≤ 1.5 x ULN.
- •Total Bilirubin ≤ 3.0 mg/dl.
- •Aspartate Aminotransferase (AST) and Alanine transaminase (ALT) ≤ 5.0 x the upper limit of normal (ULN).
- •Females of childbearing potential must have a negative serum pregnancy test.
- •Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last BBI608 dose.
排除标准
- •Have had any t a)-i) treatment less than 28 days prior to beginning the enrolment.
- •Radiation therapy
- •Hormone therapy
- •Immune therapy
- •Hyperthermia
- •Surgical procedure
- •Local therapy (such as RFA, PEIT, MCT)
- •other anti- tumour treatment
- •Have had a brain metastases with a symptom or requiring treatment.
- •Have had coinstantaneous active multiple cancers.
- •Have had a carcinomatous pleural effusion, ascites, or cardiac effusion requiring treatment.
- •Esophageal varix requiring treatment.
- •Patient of pregnancy or possibility of pregnancy, and planning breastfeeding by the end of BBI608 administration after 30days.
- •Crohns disease, ulcerative colitis, or historical surgery of extensively small intestine resection.
- •Unable or unwilling to swallow BBI608 capsules or Sorafenib tablets.
- •Uncontrolled inter-current illness (such as Grade 3active infection, or serious respiratory disease).
- •HIV infection.
- •Abnormal ECGs which are clinically significant within 28 days before enrolment.
- •Patients who are New York Heart Association (NYHA) functional classes III, or IV, or unstable angina.
- •Patients newly expressing angina within three months before the enrolment.
- •Have had myocardial infarction within six months before the enrolment.
- •Administrating with antiarrhythmic drug.
- •Have received other investigational products or post-marketing investigational products within 4 weeks of the first dose of BBI
- •Prior treatment with BBI
- •Hypersensitivity to Sorafenib or any other component of Sorafenib.
- •Ineligible for participation in the study in the opinion of the Investigators.
研究组 & 干预措施
BBI608 puls Sorafenib
Experimental
干预措施: BBI608 (Drug)
BBI608 puls Sorafenib
Experimental
干预措施: Sorafenib (Drug)
结局指标
主要结局
Assessment of dose-limiting toxicities (DLTs).
时间窗: 29 days
Assessment of safety and tolerability of BBI608 given in combination with Sorafenib by reporting of adverse events and serious adverse events.
时间窗: 7 month
Pharmacokinetic profile of BBI608 when administered in combination with Sorafenib.
时间窗: On day 1: Prior to BBI608 dosing and 2,4,6,8,10,12 and 24 hours after the first dose. On day 29: Prior to BBI608 dosing and 2,4,6,8,10,12 and 24 hours after the first dose.
次要结局
- Assessment of the preliminary anti-tumour activity.(Approximately 7 months)
- Overall Survival(Approximately 1 year)
- Progression Free Survival(Approximately 7 month)
研究者
研究点 (1)
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