NCT00352131已完成1 期
A Phase I Study to Assess the Safety and Pharmacokinetics of huC242-DM4 Administered as a Single Intravenous Infusion Once Every Three Weeks to Subjects With Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Dose-limiting toxicity
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as maytansinoid DM4-conjugated humanized monoclonal antibody huC242, 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.
PURPOSE: This phase I trial is studying the side effects and best dose of maytansinoid DM4-conjugated humanized monoclonal antibody huC242 in treating patients with solid tumors that cannot be removed by surgery or have spread to other parts of the body.
详细描述
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity and maximum tolerated dose of maytansinoid DM4-conjugated humanized monoclonal antibody huC242 in patients with inoperable or metastatic colorectal cancer, pancreatic cancer, or other solid tumors.
Secondary
- Determine the qualitative and quantitative toxicities of this drug in these patients.
- Characterize the pharmacokinetics of this drug in these patients.
- Describe any antitumor activity of this drug in these patients.
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed solid tumor
- •Inoperable or metastatic disease
- •Failed standard therapy
- •Confirmed cancer antigen (CanAg) expression
- •Patients must have non-colorectal cancer or pancreatic cancer
- •Tumor must have a homogeneous pattern (i.e., staining present in > 75% of tumor cells for CanAg) and are 2+ or 3+ intensity by immunohistochemistry * No known leptomeningeal disease or progressive brain disease
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 12 weeks
- •Absolute neutrophil count ≥ 1,500/mm³
- •Hemoglobin ≥ 9 g/dL (transfusion allowed)
- •Platelet count ≥ 100,000/mm³
- •aPTT and INR ≤ 1.5 times upper limit of normal (ULN)
- •Creatinine ≤ 1.5 mg/dL
- •Creatinine clearance ≥ 60 mL/min
- •Bilirubin ≤ 1.5 mg/dL
- •AST and ALT < 2.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 30 days after completion of study treatment
- •No hypersensitivity to agents of the same class as the study drug, humanized or nonhumanized antibodies, or immunoconjugates
- •No active, uncontrolled infection
- •No hepatitis B surface antigen or hepatitis C antibody positivity
- •No history of alcoholic liver disease
- •No serious medical or psychiatric disorder that would preclude compliance with study requirements
- •No peripheral neuropathy > grade 1
- •No other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage A low-grade prostate cancer
- •No severe concurrent disease or condition that, in the opinion of the investigator, would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Recovered from prior therapy
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin C)
- •At least 4 weeks since prior radiotherapy, immunotherapy, or hormone therapy for cancer
- •At least 4 weeks since prior major surgery
- •No concurrent chemotherapy, other immunotherapy, radiotherapy, or other investigational therapy
- •Palliative radiotherapy for related bone metastases allowed
- •No other concurrent anticancer therapy
排除标准
- 未提供
结局指标
主要结局
Dose-limiting toxicity
时间窗: for the duration of the trial
Maximum tolerated dose
时间窗: for the duration of the trial
次要结局
- Toxicity(for the duration of the trial)
- Pharmacokinetics(for the duration of the trial)
- Antitumor activity(for the duration of the trial)
研究者
研究点 (2)
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