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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Urothelial Carcinoma

Intervention / Treatment
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* Drug: BIBF1120


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FGFR3 mutated<br>BIBF 1120 in patients with advanced FGFR3 mutated | Drug: BIBF1120<br>* BIBF1120 200 mg two times per day orally<br>* Other names: Nintedanib;|
| Experimental: FGFR3 overexpressed<br>BIBF 1120 in patients with advanced FGFR3 overexpressed | Drug: BIBF1120<br>* BIBF1120 200 mg two times per day orally<br>* Other names: Nintedanib;|
| Experimental: FGFR3 wild type<br>BIBF 1120 in patients with advanced FGFR3 wild type | Drug: BIBF1120<br>* BIBF1120 200 mg two times per day orally<br>* Other names: Nintedanib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate assessed by RECEST version 1.1 | To define the response rate of BIBF1120 in patients with advanced FGFR3-mutated,overexpressed,wild type UC and who have failed platinum-based chemotherapy. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urothelial carcinoma, BIBF1120