Phase II open label single arm exploratory trial of oral afatinib monotherapy following platinum failure for patients with advanced/metastatic urothelial tract carcinoma with ERBB receptor deregulation. - Afatinib Phase II trial in HER2/3 mutated urothelial cancer

Boehringer Ingelheim España, S.A.0 个研究点目标入组 350 人开始时间: 2016年3月18日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•-recurrent or metastatic urothelial cancer
•-patients must have failed prior platinum based treatment (adjuvant or 1st line)
•-tumour sample for HER2/3 mutation testing and/or assessment of markers to determine basal histology must be available
•Further criteria apply
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•-Prior use of EGFR, ERBB2 or ERBB3 targeted treatment
•-Chemotherapy within 4 weeks prior to the start of study treatment. Biological therapy or investigational agents within 4 weeks prior to the start of study treatment or prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first
•-Known brain metastases or signs hereof, uncontrolled spinal cord compression or leptomeningeal carcinomatosis
•Further criteria apply

发起方