NCT01507168已完成2 期
A Randomised, Placebo-controlled, Double-blind, Multicenter Phase II Trial of Intravenous GC33 at 1600 mg Q2W in Previously Treated Patients With Unresectable Advanced or Metastatic Hepatocellular Carcinoma (HCC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 57
- 主要终点
- Progression-free survival (tumor assessments according to RECIST criteria)
研究概览
简要总结
This randomized, placebo-controlled, multicenter study will evaluate the efficacy and safety of GC33 (RO5137382) in previously treated patients with unresectable advanced or metastatic hepatocellular carcinoma. Participants will be stratified according to the level of GPC-3 expression in tumors and randomized to receive either GC33 (1600 mg intravenously) or placebo on Days 1 and 8 of Cycle 1 and every 2 weeks thereafter. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, >/= 18 years of age
- •Histologically confirmed hepatocellular carcinoma (without fibro-lamellar subtype)
- •Prior treatment with at least 1 systemic agent, with documented progressive disease after systemic agent(s), or documented adverse event(s) associated with prior systemic agent(s) that resulted in discontinuance of that (those) agent(s)
- •Not a candidate for curative treatments (e.g. resection, transplantation)
- •Child-Pugh A (score of 5-6)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Adequate hematologic, hepatic and renal function
- •Ability to provide, for central review, a tumor tissue sample to determine the level of GPC-3 expression by IHC
- •Measurable disease by RECIST criteria
排除标准
- •Child Pugh B or C
- •Known hepatocellular carcinoma with fibro-lamellar histology
- •Known brain or leptomeningeal metastases
- •Active infectious diseases requiring treatment except for hepatitis B and C
- •History of organ allograft including liver transplant
- •Anticipated or ongoing administration of anticancer therapies other than those administered in this study
- •Anticancer treatment within 2 weeks prior to entering the study
- •Patients who have not fully recovered from toxicities associated with previous HCC loco-regional or systemic therapies
- •Patients receiving interferon therapy
- •Pregnant or lactating women
- •Known HIV positivity or AIDS-related illness
- •History of significant hypersensitivity to similar agents (monoclonal antibody, protein-included drugs, Chinese hamster ovary products)
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
GC33 (RO5137382)
Experimental
干预措施: GC33 (Drug)
结局指标
主要结局
Progression-free survival (tumor assessments according to RECIST criteria)
时间窗: approximately 24 months
次要结局
- Overall survival(approximately 32 months)
- GPC-3 expression in tumor tissue (biopsy) by immunohistochemistry (IHC) assay(at screening)
- Time to progression (TTP): Time from randomization to first documented disease progression(approximately 24 months)
- Disease control rate (DCR): Complete response, partial response or stable disease lasting at least 6 weeks(approximately 24 months)
- Safety: Incidence of adverse events(approximately 24 months)
- Pharmacokinetics: Serum concentrations (Cmax,Cmin)(Multiple sampling pre- and post-dose Days 1 and 8 Cycle 1, Day 1 Cycle 6, pre-dose Day 1 Cycles 2-11)
研究者
研究点 (57)
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