A phase II/III, randomised, two-arm comparison of maintenance lapatinib versus placebo after first-line chemotherapy in patients with HER1 and/or HER2 overexpressing locally advanced or metastatic bladder cancer

Queen Mary, University of London (UK)0 个研究点目标入组 232 人开始时间: 2010年3月31日最近更新: 2022年4月19日

适应症

试验速览

•1. Histologically confirmed metastatic or locally advanced stage IV transitional cell carcinoma of the urothelium
•2. Able to commence study drug 3 - 8 weeks after completion of 1st line chemotherapy for metastatic bladder cancer
•3. HER1 and/or HER 2 positive, confirmed by central lab
•4. Objective response or stable disease following 4 - 8 cycles of first-line chemotherapy
•5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 3
•6. Left ventricular ejection fraction (LVEF) within normal range as measured by ECHO or MUGA
•7. Written informed consent
•8. Aged over 18 years, either sex

•1. Progression with first-line chemotherapy for metastatic disease
•2. Previous anti-HER1 or HER2 therapy
•3. More than one line of chemotherapy for metastatic or locally advanced disease
•4. Significant cardiac disease
•5. Patients receiving less than 4 or more than 8 cycles of chemotherapy before randomisation
•6. Major surgery or curative radiotherapy after chemotherapy (palliative radiotherapy is allowed)

发起方

Queen Mary, University of London (UK)