EUCTR2012-000660-22-ES进行中（未招募）1 期
A randomized, multicenter, adaptive phase II/III study to evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) versus taxane (docetaxel or paclitaxel) in patients with previously treated locally advanced or metastatic HER2-positive gastric cancer, including adenocarcinoma of the gastroesophageal junction.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 412
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
- All
入选标准
- •? Adult patients >/=18 years of age
- •? Histologically or cytologically confirmed Her2+ AGC (advanced gastric cancer) and must have experienced documented objective
- •radiographic or pathologic disease progression during or after first-line therapy for their disease.
- •? must have received at least one prior chemotherapy regimen for
- •AGC; prior therapy does not need to have included HER2-directed therapy.
- •? Patients must have measurable and/or non-measurable disease which must be evaluable per RECIST 1.1 ? ECOG Performance Status 0 or 1
- •? Adequate organ function as determined by laboratory results.
- •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 232
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •? An interval shorter than 21 days from the last dose of chemotherapy or HER2-directed therapy until the time of randomization
- •? Prior treatment with trastuzumab emtansine, docetaxel, or paclitaxel either as single agents or as part of a treatment regimen. Prior treatment with trastuzumab, lapatinib, or pertuzumab is allowed
- •? Treatment with any anticancer investigational drug within 21 days prior to commencing study treatment ? Brain metastases that are untreated or symptomatic or require any radiation, surgery, or steroid therapy to control symptoms from brain
- •metastases within 1 month of randomization
- •? Inadequate cardiopulmonary function.
研究者
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