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

Phase 2

• Conditions: Urothelial Carcinoma
• Interventions: Drug: BIBF1120

• Registration Number: NCT02278978
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-28
• Study First Submitted QC: 2014-10-29
• Study First Posted: 2014-10-30
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-10
• Last Update Posted: 2015-05-12
• Primary Completion: 2015-12
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 129

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FGFR3 overexpressed	BIBF1120	BIBF 1120 in patients with advanced FGFR3 overexpressed
FGFR3 mutated	BIBF1120	BIBF 1120 in patients with advanced FGFR3 mutated
FGFR3 wild type	BIBF1120	BIBF 1120 in patients with advanced FGFR3 wild type

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Chia-Chi Lin; 🇨🇳 Taipei, Taiwan