A Phase 2 Study of SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC) Subjects Who Failed Prior Treatment With Sorafenib
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 24
- 主要终点
- Disease Control Rate (DCR) at 16 Weeks for Patients Treated With Guadecitabine After Failure of Sorafenib
研究概览
简要总结
A Phase 2 open-label, single-arm, non-randomized study in the treatment of advanced hepatocellular carcinoma (HCC) patients who failed prior treatment with sorafenib using a Simon's 2-stage design. A set minimum number of patients must demonstrate disease control at 16 weeks to proceed to Stage 2. At Stage 2, a set number of patients must have disease control at 16 weeks to declare that SGI-110 is of interest in the treatment of advanced HCC after failure of prior sorafenib.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Histological or cytological confirmed hepatocellular carcinoma with advanced stage disease
- •Received prior sorafenib treatment, and showed evidence of disease progression, which is defined as Investigator verified radiologic progression, or intolerance of prior systemic therapy, which is defined as having had clinically significant adverse events that persisted despite one or more dose reductions or interruptions
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Acceptable organ function
- •Signed an approved informed consent
排除标准
- •Known hypersensitivity to SGI-110
- •Adequate washout of prior radiation, chemotherapy or other locoregional therapy
- •Abnormal left ventricular ejection fraction
- •Uncontrolled ischemic heart disease or a history of congestive cardiac failure
- •Known brain metastases
- •Clinically evident ascites
- •Child-Pugh C cirrhosis or Child-Pugh B cirrhosis with more than 7 points
- •Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, non-metastatic prostate cancer with normal prostate-specific antigen (PSA) or other cancer from which the subject has been disease free for at least three years
- •Known history of human immunodeficiency virus (HIV)
研究组 & 干预措施
SGI-110
SGI-110 administered subcutaneously (SC) daily on Days 1 - 5 every 28 days
干预措施: SGI-110 (Drug)
结局指标
主要结局
Disease Control Rate (DCR) at 16 Weeks for Patients Treated With Guadecitabine After Failure of Sorafenib
时间窗: 16 weeks
Percentage of patients achieving a best overall response of complete response (CR) or partial response (PR) plus subjects with stable disease at 16 weeks after the start of treatment. Response was assessed based on the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for target and non-target lesions using computed tomography (CT) or magnetic resonance imaging (MRI) as follows: Complete Response (CR), disappearance of all target lesions, disappearance of all non-target lesions, and normalization of tumor marker level; Partial Response (PR), at least a 30% decrease in the sum of diameters of target lesions from baseline; Progressive Disease (PD), at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions, and unequivocal progression of non-target lesions; Stable Disease, neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for PD (Eisenhauer et al. 2009, Eur. J. Cancer 45:228-247).
次要结局
- Progression-free Survival(Through completion of response assessments (i.e., until disease progression or treatment discontinuation), an average of 112 days.)
- Overall Survival(Through completion of study survival follow-up, an average of 270 days.)
- Safety and Tolerability of Guadecitabine(Varied by patient (median number of treatment cycles was 2.0 (range 2-8) in 60 mg/m^2 group, and 4.0 (range 1-13) in 45 mg/m^2 group)
- Alpha Fetoprotein Response as a Result of Guadecitabine Administration(Varied by patient (median number of treatment cycles was 2.0 (range 2-8) in 60 mg/m^2 group, and 4.0 (range 1-13) in 45 mg/m^2 group)
- Duration of Response(From time of first response until disease progression or date of death due to any cause, whichever occurred earlier; an average of 192 days.)