Status:
UNKNOWN
BIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Urothelial Carcinoma
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- KPS 60%
- Histological confirmation of urothelial carcinoma , with metastatic disease
- Measurable disease
- Previously treated with platinum-based chemotherapy administered
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2016
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT02278978
Start Date
October 1 2014
End Date
March 1 2016
Last Update
May 12 2015
Active Locations (1)
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1
Chia-Chi Lin
Taipei, Taiwan