NCT01908426已完成3 期
A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Exelixis
- 入组人数
- 707
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with placebo on overall survival in subjects with advanced hepatocellular carcinoma who have received prior sorafenib.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histological or cytological diagnosis of HCC.
- •The subject has disease that is not amenable to a curative treatment approach.
- •Received prior sorafenib.
- •Progression following at least 1 prior systemic treatment for HCC.
- •Recovery to from toxicities related to any prior treatments.
- •ECOG performance status of 0 or
- •Adequate hematologic and renal function, based upon meeting protocol defined laboratory criteria within 7 days before randomization.
- •Child-Pugh Score of A.
- •Antiviral therapy per local standard of care if active hepatitis B (HBV) infection.
- •Sexually active fertile subjects(male and female)must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment.
- •Female subjects of childbearing potential must not be pregnant at screening.
排除标准
- •Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
- •Receipt of more than 2 prior systemic therapies for advanced HCC.
- •Any type of anticancer agent (including investigational) within 2 weeks before randomization.
- •Radiation therapy within 4 weeks (2 weeks for radiation for bone metastases) or radionuclide treatment within 6 weeks of randomization.
- •Prior cabozantinib treatment.
- •Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization.
- •Concomitant anticoagulation, at therapeutic doses, with anticoagulants.
- •Serious illness other than cancer that would preclude safe participation in the study.
- •Subjects with untreated or incompletely treated varices with bleeding or high risk for bleeding.
- •Moderate or severe ascites.
- •Pregnant or lactating females.
- •Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low-grade tumors.
研究组 & 干预措施
Cabozantinib (XL184)
Experimental
Cabozantinib (XL184) 60 mg tablet once daily
干预措施: Cabozantinib tablets (Drug)
Placebo
Placebo Comparator
Oral cabozantinib-matched placebo tablet once daily
干预措施: Placebo tablets (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to 45 months
The primary analysis of OS is defined as the time from randomization to death from any cause. The analysis was based on a second planned interim analysis prespecified to be performed at approximately the 75% information fraction (ie, at approximately 466 deaths). The data cutoff date for this event-driven analysis in the Intent to Treat (ITT) population was 01 June 2017. Median OS was calculated using the Kaplan-Meier estimates.
次要结局
- Progression-Free Survival (PFS)(Up to 45 months)
- Objective Response Rate (ORR)(ORR is measured by radiologic assessment every 8 weeks after randomization until disease progression or discontinuation of study treatment (up to 45 months))
研究者
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