Phase II study of the fully human monoclonal antibody against transforming growth factor-beta (TGF-beta) receptor ALK1 (PF-03446962) in relapsed or refractory urothelial cancer (UC) failing first-line treatment. - PF-03446962 (anti-ALK-1 mAb) in relapsed/refractory Urothelial Cancer

ISTITUTO NAZIONALE PER LA CURA TUMORI0 个研究点开始时间: 2012年3月7日最近更新: 2013年10月7日

试验速览

暂无简介。

•Age > 18 years. • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. • Life expectancy of at least 12 weeks. • Histologically confirmed diagnosis of transitional cell tumors of the bladder or the urothelium. Presence of divergent histologies (ex. Squamous-cell histology) may be acceptable provided that there is prevalence of urothelial component. • Locally advanced/Metastatic disease. • Measurable disease criteria, defined as = 1 unidimensionally measurable lesion = 2 cm by conventional techniques or = 1 cm by spiral CT scan. • Failure of no more than 1 cisplatin-based conventional chemotherapy regimen for metastatic disease (pure second-line setting). • Neoadjuvant/adjuvant therapy considered if relapse occurred within 6 months of the last cycle of chemotherapy.
•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 35
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Treatment with any of the following anti-cancer therapies: o radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of PF-03446962 OR o chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of PF-03446962. • cardiovascular conditions within the past 6 months. • History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis.

发起方

ISTITUTO NAZIONALE PER LA CURA TUMORI