NCT02641873已完成1 期
A Phase I Study of BBI608 Administered With FOLFIRI + Bevacizumab in Adult 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
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Incidence of adverse events (AEs), serious adverse events (SAEs) [Safety and Tolerability]
研究概览
简要总结
This is an open-label, multicenter, phase 1 study of BBI608 in combination with FOLFIRI + Bavacizumab. This study population is adult Japanese patients with metastatic colorectal cancers in FOLFIRI + Bevacizumab 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
- •A histologically confirmed advanced unresectable, metastatic or recurrent colorectal carcinoma
- •Evaluable patient by RECISTversion 1.1
- •≥ 20 years of age
- •Life expectancy ≥ 3 months.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Patients with following organ function within 14 days before enrollment (on the basis of the most recent data during the period if multiple data are available)
- •Hemoglobin (Hg) ≥ 9.0 g/dL
- •Neutrophil count ≥ 1.5 x 103/μL
- •Platelet count ≥ 10 x 104/μL
- •Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × institutional upper limit of normal (ULN) [≤ 5 × ULN in presence of liver metastases ]
- •Total bilirubin ≤ 1.5 × institutional ULN [≤ 2 × ULN in presence of liver metastases ]
- •Creatinine ≤ 1.5 × institutional ULN
- •Proteinuria by dipstick urine analysis ≤ 1+. [ UPCR (Urine Albumin-to-Creatinine Ratio) ≤ 1, or protein volume of 24-hour urine collection ≤ 1 g, in the case of patients with a 2+ urine dipstick reading]
- •For female patient of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 30 days after the last protocol treatment dose or 6 months after Bevacizumab treatment.. For male patient of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 90 days after the last protocol treatment dose or 6 months after Bevacizumab treatment
- •Females of childbearing potential have a negative urine pregnancy test
- •Patients who have provided written voluntary consent in person to participate in this study after fully receiving and understanding the information about this study, including study
排除标准
- •Anti-cancer chemotherapy, radiotherapy, immunotherapy, or hormone therapy, or heart therapy within 21 days of the first dose of BBI608
- •Major surgery within 28 days prior to first dose
- •Have had a brain metastases with a symptom or requiring treatment
- •Have had coinstantaneously active multiple primary cancer
- •Have had a carcinomatous pleural effusion, ascites, or cardiac effusion requiring treatment
- •Crohn's disease, ulcerative colitis, small intestine resection, diarrhea (watery diarrhea), paralysis intestinal, Intestinal obstruction
- •Gastrointestinal perforation, tracheo-oesophageal fistula, fistula
- •Unable or unwilling to swallow BBI608 capsules
- •Uncontrolled inter-current illness (such as Grade 3 active infection, or serious respiratory disease)
- •Uncontrolled hypertension
- •Patients with recent history of hemoptysis of more than 2.5 mL of red blood within 28days before the enrolment
- •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 (90 days) before the enrolment
- •Have had myocardial infarction within six months (180 days)before the enrolment
- •Administrating with antiarrhythmic drug
- •Patients who are planning to breast-feeding by whichever 30 days after the last administration of BBI608 or by 6 months after the last administration of Bevacizumab
- •Patients of pregnancy or possibility of pregnancy at current time or possibility of pregnancy within 6 months after the last administration of Bevacizumab
- •Have received other investigational products or not finished the assessment in any clinical study within 28 days before enrollment
- •Known severe hypersensitivity to 5-FU/ levofolinate/ irinotecan/Bevacizumab
- •Administration of atazanavir sulfate
- •Prior treatment with BBI608
- •Ineligible for participation in the study in the opinion of the Investigators
研究组 & 干预措施
BBI608 + FOLFIRI +Bevacizumab
Experimental
干预措施: BBI608 (Drug)
BBI608 + FOLFIRI +Bevacizumab
Experimental
干预措施: 5-FU (Drug)
BBI608 + FOLFIRI +Bevacizumab
Experimental
干预措施: Irinotecan (Drug)
BBI608 + FOLFIRI +Bevacizumab
Experimental
干预措施: Levofolinate (Drug)
BBI608 + FOLFIRI +Bevacizumab
Experimental
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Incidence of adverse events (AEs), serious adverse events (SAEs) [Safety and Tolerability]
时间窗: 12 months
Safety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs)
Number of participants with Dose-limiting toxicities (DLT) [Safety and Tolerability]
时间窗: 12 months
Safety and tolerability assessed by determination of unacceptable toxicity in patients.
Cmax (Peak plasma concentration)
时间窗: Day 1: prior to BBI608 and 2,4,6,8,10,12,24 hours after the first dose.
Cmax (Peak plasma concentration)
AUC0-24h (Area under the plasma concentration versus time curve)
时间窗: Day 1: prior to BBI608 and 2,4,6,8,10,12,24 hours after the first dose.
AUC0-24h (Area under the plasma concentration versus time curve)
次要结局
- Preliminary anti-tumour activity(6 months(an expected average))
- Progression Free Survival (PFS)(12 months)
研究者
研究点 (2)
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