BIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma

• Status: Unknown status
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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 chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Nintedanib

Criteria

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