BIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma
This trial is active, not recruiting.
|Sponsor||National Taiwan University Hospital|
|Start date||October 2014|
|End date||December 2015|
|Trial size||129 participants|
|Trial identifier||NCT02278978, 201306022MIPB|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Response rate assessed by RECEST version 1.1
time frame: 2 months
Male or female participants at least 20 years old.
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
|Official title||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|
|Principal investigator||Chia-Chi Lin, Ph.D|
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