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临床试验/JPRN-jRCT2080223113
JPRN-jRCT2080223113未知2 期

AN OPEN-LABEL, MULTICENTER EXTENSION STUDY OF TRASTUZUMAB EMTANSINE ADMINISTERED AS A SINGLE AGENT OR IN COMBINATION WITH OTHER ANTI-CANCER THERAPIES IN PATIENTS PREVIOUSLY ENROLLED IN A GENENTECH AND/OR F. HOFFMANN-LA ROCHE LTD-SPONSORED TRASTUZUMAB EMTANSINE STUDY

CHUGAI PHARMACEUTICAL CO., LTD.0 个研究点目标入组 720 人开始时间: 2016年2月24日最近更新:

试验速览

阶段
2 期
入组人数
720

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 18age old 至 ot applicable(—)
性别
All

入选标准

  • Completed single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment in the parent study or who continue to receive single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment at the time of the parent study closure and received the last study drug dose within the 6 weeks (42 days) prior to the first dose of study therapy on the extension study
  • -Expectation by the investigator that the patient may continue to benefit from additional single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment

排除标准

  • -AE(s) leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment discontinuation in the parent study
  • - Ongoing SAE(s) from the parent study
  • - PD (except for isolated brain metastases under certain conditions) on single-agent trastuzumab emtansine or a trastuzumab emtansine-containing regimen during the parent study or before starting the extension study, with the exception of patients from Study TDM4688g with early PD who went on to receive pertuzumab + trastuzumab emtansine treatment and have not experienced further disease progression on the combination regimen

研究者

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