NCT00976170已完成1 期
A Phase I, Open-Label, Multi-center, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of GC33 in Combination With Sorafenib (Nexavar®) in Patients With Advanced or Metastatic Hepatocellular Carcinoma (HCC).
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
- 42
- 试验地点
- 7
- 主要终点
- Toxicity evaluation in accordance with CTCAE v3.0
研究概览
简要总结
This phase I trial is studying the safety and best dose of GC33 and Sorafenib in combination in patients with advanced or metastatic liver cancer.
详细描述
This is a Phase I open-label dose escalation study of GC33 in combination with Sorafenib in patients with advanced or metastatic HCC. This study is designed to evaluate safety, tolerability, pharmacokinetics, and efficacy. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose has been established.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Signed written Institutional Review Board/Ethical Committee approved informed consent form.
- •Male or female ≥18 years old.
- •Life expectancy ≥3 months.
- •ECOG Performance Status of 0-
- •Histologically confirmed hepatocellular carcinoma.
- •Not a candidate for curative treatments.
- •Child-Pugh A
- •Hematological, Biochemical and Organ Function:
- •AST (SGOT): ≤5.0 × ULN,
- •ALT (SGPT): ≤5.0 × ULN,
- •Total Bilirubin: ≤1.5mg/dL,
- •Platelets: ≥100,000/μL,
- •Absolute Neutrophil Count: ≥1,500/μL,
- •Serum creatinine: ≤2.0 × ULN,
- •PT-INR: ≤2.0
- •Ability to provide a tumor tissue sample either by:
- •A formalin fixed paraffin embedded block sample within 12 months prior to informed consent for HCC diagnosis
- •Undergo a biopsy to confirm HCC diagnosis
- •Measurable disease.
排除标准
- •Child-Pugh B or C
- •Patient who have taken Sorafenib previously.
- •Difficulty or inability to swallow pills.
- •Pregnant or lactating women or women of child-bearing potential and men of childbearing potential not willing to use effective means of contraception.
- •Patients known to be positive for Human immunodeficiency virus infection.
- •Active infectious diseases requiring treatment except for hepatitis B and C.
- •Other malignancies within the last 5 years.
- •History of transplantation (organ, bone marrow transplantation, Peripheral blood stem cell transplantation, etc.).
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements..
- •Patients with known brain metastases or other central nervous system disease/disorders.
- •Uncontrolled hypertension defined as systolic blood pressure >150 mmhg or diastolic blood pressure >90 mmHg, despite optimal medical management.
- •Non-tumor related thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- •Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 3, any other hemorrhage/bleeding event ≥ CTCAE Grade 4 within 4 weeks of first dose of study drug.
- •Serious non-healing wound, ulcer, or bone fracture.
- •Patients who received major surgery, local therapy for HCC, chemotherapy, radiotherapy, hormone-therapy, immunotherapy, or another investigational drug within 4 weeks prior to Day 1(6 weeks for nitrosoureas, mitomycin, and bevacizumab; 1 week for tumor biopsy).
- •Patients who received the following treatments within 2 weeks prior to Day 1:
- •Anticoagulant or thrombolytic agents for therapeutic purposes,
- •Systemic anti-viral therapy for hepatitis C and Interferon therapy for hepatitis B,
- •Blood transfusion including all blood products
- •Known history of hypersensitivity to similar agents.
- •Patients receiving any medications or substances that are inducers of CYP3A4 are ineligible: rifampin, St. John's wort, phenytoin, carbamazepine, phenobarbital and dexamethasone.
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry.
研究组 & 干预措施
1
Experimental
干预措施: GC33(RO5137382) (Drug)
1
Experimental
干预措施: Sorafenib (Drug)
结局指标
主要结局
Toxicity evaluation in accordance with CTCAE v3.0
时间窗: Continuous
Dose limiting toxicity and maximum tolerated dose
时间窗: Continuous
次要结局
- RECIST criteria (version 1.0) for response evaluation by CT/MRI in target and non-target lesions of HCC(every 2 months)
- Repeat-dose pharmacokinetic behavior of GC33 and Sorafenib(Continuous)
研究者
研究点 (7)
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