EUCTR2012-003977-24-GB进行中（未招募）1 期
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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Subjects who are 18 years of age or older
- •2. Subjects who have histological or cytological confirmed HCC, with advanced stage disease
- •3. Subject with life expectancy of at least 16 weeks
- •4. Subjects who have 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. Subjects may have received prior systemic therapy other than sorafenib, or other treatment for HCC such as embolization, chemoembolization, intra-arterial chemotherapy, ethanol injection, ablative therapy, cryosurgery, or other locoregional or targeted therapy.
- •5. Subjects with ECOG performance status of 0-1
- •6. Subjects with acceptable organ function, as evidenced by laboratory data:
- •A. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 5.0 X upper limit of normal (ULN)
- •B. Total serum bilirubin = 2 mg/dL
- •C. Absolute neutrophil count (ANC) = 1000 cells/mm3
- •D. Platelets = 75,000/mm3
- •E. Serum creatinine levels = 1.25 X ULN OR calculated (by Cockcroft-Gault formula)/measured creatinine clearance (CrCL) = 50 mL/min
- •F. Prothrombin time (PT) = 6 sec above ULN, or international normalized ratio (INR) = 2.3
- •7. Subjects and their partners with reproductive potential must agree to use effective contraceptive measures during the study and for 3 months following the last dose of study drug. Effective contraception includes methods such as oral contraceptives, double-barrier method (condom plus spermicide or diaphragm), or abstaining from sexual intercourse.
- •8. Subjects who sign an approved informed consent form for the study
- •9. Subjects who are willing and able to comply with the protocol and study procedures, in particular willingness to undergo tumor biopsy before (at baseline pretreatment), and after treatment with SGI-110 (Day 8 of Cycles 1 or 2)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 21
排除标准
- •1. Subjects who have known hypersensitivity to SGI-110
- •2. Subjects who have received radiation therapy, other locoregional therapy, or chemotherapy within 4 weeks prior to the first dose of study drug. Subjects treated with sorafenib or other targeted agents must have been at least 2 weeks post treatment or at least 5 half-lives from last treatment. Subjects must have recovered from any significant toxicities associated with those therapies.
- •3. Subjects who are at poor medical risk because of other systemic diseases or active uncontrolled infections
- •4. Subjects with a life-threatening illness, medical condition or organ system dysfunction, or other reasons which, in the Investigator’s opinion, could compromise the subject’s safety, interfere with the metabolism of SGI-110, or compromise the integrity of the study outcomes
- •5. Subjects with abnormal left ventricular ejection fraction (<50%) on echocardiogram or multiple-gated acquisition scan (MUGA)
- •6. Subjects with uncontrolled ischemic heart disease or a history of congestive cardiac failure of = Grade 3 severity according to New York Heart Association (NYHA)
- •7. Subjects with known brain metastases
- •8. Subjects with esophageal or gastric variceal bleeding within the last 6 months. Subjects at risk for varices (based on the following: known history of esophageal or gastric varices; evidence of hepatic cirrhosis and/or portal hypertension including biopsy-proven cirrhosis, hypersplenism, or radiographic findings of varices) will be screened (using either esophagogastroduodenoscopy [EGD] or capsule endoscopy) for esophageal varices, unless such screening has been performed in the past one year from study entry and the subject is receiving medical treatment for prophylaxis of variceal bleeding, such as non-selective beta blockade. If varices are identified that require intervention (banding), the subject will not be eligible until varices are adequately treated.
- •9. Subjects with clinically evident ascites (minimal, medically controlled ascites detectable on imaging studies only is allowed)
- •10. Subjects with Child-Pugh C cirrhosis or Child-Pugh B cirrhosis with more than 7 points
- •11. Subjects with encephalopathy in the last 6 months; however, subjects who are on stable dose or schedule of lactulose and/or neomycin and xifaxan are allowed
- •12. Subjects with active hepatitis B infection not on adequate antiviral therapy13. Subjects with prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, non-metastatic prostate cancer with normal PSA or other cancer from which the subject has been disease free for at least three years
- •14. Subjects with known history of human immunodeficiency virus (HIV)
研究者
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