NCT01513083已完成1 期
A Phase I, Open Label, Parallel Group, Pharmacokinetic Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function
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
- 28
- 主要终点
- Pharmacokinetics: Area under the concentration-time curve
研究概览
简要总结
This open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 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
- •Adult patients, >/= 18 years of age
- •Histologically or cytologically documented invasive metastatic breast cancer
- •Human epidermal growth factor receptor 2 (HER2) -positive disease
- •Adequate bone marrow and organ function (other than hepatic dysfunction allowed by protocol)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •Left ventricular ejection fraction >/=50%
- •Normal hepatic function, or mild to moderate hepatic impairment (Child-Pugh Class A or B)
排除标准
- •History of Grade >/=3 infusion reaction, hypersensitivity reaction, or pneumonitis in response to trastuzumab
- •Investigational therapy or any other anticancer therapy </=28 days before first study treatment
- •Previous treatment with trastuzumab emtansine
- •Brain metastases that are untreated or symptomatic or require therapy to control symptoms or any radiation, surgery or other therapy to control symptoms from brain metastases within 1 month of the first study treatment
- •History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those mentioned above
- •Current peripheral neuropathy of Grade >/=2
- •Child-Pugh Class C hepatic impairment
- •Encephalopathy >/= Grade 2
- •For patients with normal hepatic function: history of drug or alcohol addiction or history of hepatitis B and/or hepatitis C
- •Active hepatitis A, B and/or C
- •Current unstable ventricular arrhythmia requiring treatment
- •History of symptomatic CHF (NYHA Classes II-IV)
- •History of myocardial infarction or unstable angina within 6 months of enrollment
- •History of a decrease in LVEF to<40% or symptomatic CHF with previous trastuzumab treatment
- •Pregnant or lactating women
- •Known HIV infection
研究组 & 干预措施
Mild hepatic dysfunction
Experimental
干预措施: trastuzumab emtansine (Drug)
Moderate hepatic dysfunction
Experimental
干预措施: trastuzumab emtansine (Drug)
Normal hepatic function
Experimental
干预措施: trastuzumab emtansine (Drug)
结局指标
主要结局
Pharmacokinetics: Area under the concentration-time curve
时间窗: Multiple sampling pre- and up to 21 days post-dose Cycles 1-3
次要结局
- Safety: Incidence of adverse events in patients with mild or moderate hepatic impairment as compared to patients with normal hepatic function(approximately 2 years)
研究者
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