A Phase 2 Study of IMC-A12 (NSC742460) in Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- PFS Rate
研究概览
简要总结
This phase II trial is studying how well IMC-A12 works in treating patients with advanced liver cancer. Monoclonal antibodies, such as IMC-A12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
详细描述
PRIMARY OBJECTIVES:
I. To determine the progression-free survival (PFS) at 4 months in patients with advanced hepatocellular carcinoma (HCC) treated with anti-IGF-1R recombinant monoclonal antibody IMC-A12.
II. To determine the best overall response rate in patients treated with this drug.
SECONDARY OBJECTIVES:
I. To determine the median overall survival of patients treated with this drug. II. To evaluate the safety, tolerability, and adverse events profile of this drug in these patients.
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
- •Histologically or cytologically confirmed hepatocellular carcinoma
- •Unresectable, locally advanced, or metastatic disease
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •Child's Pugh score A5, A6, B7, or B8
- •No known brain metastases
- •No history of primary CNS tumors
- •ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- •Life expectancy > 3 months
- •Leukocytes ≥ 3,000/mcL
- •Absolute neutrophil count ≥ 1,500/mcL
- •Platelet count ≥ 75,000/mcL
- •Total bilirubin ≤ 2 times upper limit of normal (ULN)
- •AST/ALT ≤ 2.5 times ULN
- •PT/INR ≤ 1.7 times ULN
- •Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
- •Fasting serum glucose ≤ 125 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No clinical encephalopathy
- •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to anti-IGF-1R recombinant monoclonal antibody IMC-A12
- •No poorly controlled diabetes mellitus
- •Patients with a history of diabetes mellitus are eligible provided their blood glucose is within normal range (fasting blood glucose < 120 mg/dL OR below ULN) and patient is on a stable dietary or therapeutic regimen for this condition
- •No concurrent uncontrolled illness including, but not limited to, any of the following:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Psychiatric illness or social situation that would preclude compliance with study requirements
- •No history of seizures not well controlled with standard medical therapy
- •No history of stroke
- •No history of another primary cancer except for the following:
- •Curatively resected nonmelanoma skin cancer
- •Curatively treated carcinoma in situ of the cervix
- •Other primary solid tumor with no known active disease present that in the opinion of the investigator would not affect treatment outcome
- •Prior local therapy (i.e., surgery, radiotherapy, hepatic arterial embolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) allowed provided the target lesion has not been treated with local therapy and/or the target lesion within the field of local therapy has shown an increase of ≥ 25% in size
- •At least 4 weeks since prior local therapy
- •No prior systemic therapy except for sorafenib tosylate
- •No prior agents targeting the IGF or IGF-1R pathway
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •No other concurrent investigational agents
- •No concurrent anticancer therapy
排除标准
- 未提供
结局指标
主要结局
PFS Rate
时间窗: At 4 months
PFS defined as the time from first date of first treatment on the study until such time as progressive disease is confirmed or upon patient death if disease progression has not been evident at that time. A Simon's optimal two stage design will be used with the following assumption: a 4 months PFS of 62% is considered acceptable while a 4 months PFS of 42% is not acceptable.
Best Overall Response Rate (ORR)
时间窗: From the start of the treatment until disease progression/recurrence
Best overall ORR will be defined as the proportion of patients achieving either confirmed partial response (PR) or confirmed complete response (CR). A Simon's optimal two stage design will be used with the following assumption: ORR of more than 20% is acceptable and an ORR less than 5% is not acceptable.
次要结局
- Median Overall Survival(Post-Treatment)