EUCTR2012-000660-22-IT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 defined as
- •unresectable and locally advanced or metastatic gastric cancer, including
- •adenocarcinoma of the GEJ, and must have experienced documented
- •objective radiographic or pathologic disease progression during or after
- •first-line therapy for their disease.
- •First-line therapy for AGC, including adenocarcinoma of the GEJ, must have included a combination of at least a platinum (e.g., cisplatin,
- •carboplatin, or oxaliplatin) AND a fluoropyrimidine (e.g., 5-FU,capecitabine, or S-1) given concurrently; prior therapy can but 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: 0
- •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 of
- •the first study treatment administration.
- •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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