EUCTR2013-000572-15-DK进行中（未招募）不适用
Investigation of immune mechanisms relating to lapatinibassociated hepatotoxicity: ex vivo T cell biology investigationrelating to lapatinib induced liver adverse events using PBMCsfrom patients selected from EGF105485 (TEACH). - PGx474 Investigation of immune mechanisms relating
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
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
- 性别
- Female
入选标准
- •Note that treatment and disease controls will only be collected if their respective, matched case is able to consent and provide a blood sample.
- •The four groups of subjects will be selected as follows: i) lapatinib-treated subjects who had a previously reported and documented hepatic serious adverse event (cases), ii) selected lapatinibtreated subjects who did not experience liver adverse events, with normal liver chemistries at baseline and throughout treatment (treatment controls) and iii) placebo treated subjects who had normal liver chemistries at baseline and throughout treatment (disease controls). Subjects for the two control groups will be matched with the casesbased on their HLA-DQA1*02:01/DRB1*07:01 allele carriage, ethnicity, study site (where possible) and country.
- •In addition, HLA-DRB1*07:01 and –DQA1*02:01 alleles are inherited together in 99.8% of the study population and genetic investigation has not determined which of the two alleles is causative for hepatotoxicity. However, three EGF105485 (TEACH) subjects have been identified with a rare mismatch of inheriting only one of these highly correlated alleles: HLA-DRB1*07:01 (1 subject, lapatinib treatment) or HLADQA1* 02:01 (2 subjects, lapatinib or placebo treatment). These three subjects were characterised as controls and reside in North America. Whole blood samples will be collected to enable comparison of T cell activation following lapatinib challenge ex vivo.
- •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 56
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 19
排除标准
- 未提供
研究者
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Investigation of immune mechanisms relating to lapatinib associated hepatotoxicity (liver toxicity)The subjects participated in the EGF105485 study, a randomized, placebo-controlled study of lapatinib in HER2-positive early-stage breast cancer. During participation in this study, subjects had blood test results that may be suggestive of liver damage.EUCTR2013-000572-15-ESGlaxoSmithKline, S.A.75
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