BIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma
A Phase II Trial of BIBF1120 in Patients With Advanced FGFR3 Mutated, FGFR3 Overexpressed, or FGFR3 Wild Type Urothelial Carcinoma of Urinary Bladder, Urethra, Ureter, and Renal Pelvis and Who Have Failed Platinum-based Chemotherapy
BIBF1120 in patients with advanced FGFR3 mutated, FGFR3 overexpressed, or FGFR3 wild type urothelial carcinoma of urinary bladder, urethra, ureter, and renal pelvis and who have failed platinum-based chemotherapy.
Response rate assessed by RECEST version 1.1
Study Arms / Comparison Groups
Description: BIBF 1120 in patients with advanced FGFR3 mutated
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
Inclusion Criteria: - KPS 60% - Histological confirmation of urothelial carcinoma , with metastatic disease - Measurable disease - Previously treated with platinum-based chemotherapy administered Exclusion Criteria: - Radiographic evidence of cavitary or necrotic tumours - Active brain metastasis.Leptomeningeal metastasis - Chemotherapy, radiotherapy, targeted therapy with monoclonal antibodies or small tyrosine kinase inhibitors - Grade 1 treatment-related toxicity from previous chemotherapy, radiotherapy, or targeted therapy - Prior treatment with BIBF 1120 or other VEGFR inhibitors - Significant cardiovascular diseases: - Pericardial effusion - Significant bleeding or thrombosis - Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug - Major injuries within the past 10 days with incomplete wound healing and/or planned surgery during the on-treatment study period
20 Years - N/A
Accepts Healthy Volunteers
Chia-Chi Lin, Ph.D, ,
National Taiwan University Hospital
Chia-Chi Lin, Ph.D, Principal Investigator, National Taiwan University Hospital