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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02278978

Enrollment

129

Registered

2014-10-30

Start date

2014-10-31

Completion date

2016-03-31

Last updated

2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial Carcinoma

Keywords

urothelial carcinoma, BIBF1120

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 chemotherapy.

Interventions

DRUGBIBF1120

BIBF1120 200 mg two times per day orally

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026