EUCTR2004-001906-29-GB进行中（未招募）1 期
Phase II study to evaluate the efficacy, safety and pharmacodynamics of lapatinib in patients with relapsed or refractory inflammatory breast cancer - Lapatinib in relapsed or refractory inflammatory breast cancer (IBC)
GlaxoSmithKline R&D Ltd0 个研究点目标入组 0 人开始时间: 2005年6月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •- Histologically confirmed breast carcinoma with clinical diagnosis of IBC
- •- Documented disease progression or relapse following treatment, which must have included a taxane and anthracycline-containing regimen in the adjuvant or metastatic setting (30 patients) plus trastuzumab (90 patinets)
- •- Tumour that overexpresses ErbB2 as 3+ by IHC or FISH-positive. The ErbB2 expression status must be documented prior to dosing.
- •- Must have life expectancy of at least 12 weeks
- •- Tumour to be accessible for biopsy
- •- Measureable disease by RECIST or clinically evaluable skin disease
- •- Male or female at least 18 years of age
- •- Female patients must either be of non-childbearing potential, or if of childbearing potential to have negative serum pregnancy test at screening and to agree to a protocol-specified method of contraception during participation in the study
- •- Able to swallow and retain oral medication
- •- ECOG performance status 0-2
- •- Recovered or stabilised from effects of previous chemotherapy, surgery or radiotherapy
- •- Have adequate bone marrow function, and renal and hepatic function
- •- Have left ventricular ejection fraction greater than or equal to 50%, or above lower limit of normal for the institution
- •- Provide written informed consent
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Female who is pregnant or lactating
- •- Patient who has malabsorption syndrome, disease affecting GI function, or resection of the stomach or small bowel
- •- Evidence of symptomatic or uncontrolled brain metastases or leptomeningeal disease. Patients with brain metastases treated by surgery and/or radiotherapy are eligible if neurologically stable and do not require steroids or anticonvulsants.
- •- Considered medically unfit by the investigator
- •- Has known hypersensitivity reaction or idiosyncrasy to drugs chemically-related to the IMP
- •- Received treatment with any investigational drug in previous 4 weeks
- •- Has received chemotherapy, immunotherapy, biologic therapy or hormonal therapy within the past 14 days (except mitomycin C within past 6 weeks)
- •- Currently receiving amiodarone or within 6 months prior to screening
- •- Currently receiving oral steroid treatment, or any other protocol-specified prohibited medication
- •- Has condition/s which will not permit compliance with the protocol
- •- Has Class II-IV heart failure (by NYHA classification system)
- •- Has a clinically significant ECG abnormality
- •- Has inadequate venous access for protocol-related blood sampling.
研究者
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