Overview

This trial is active, not recruiting.

Condition urothelial carcinoma
Treatment bibf1120
Phase phase 2
Sponsor National Taiwan University Hospital
Start date October 2014
End date December 2015
Trial size 129 participants
Trial identifier NCT02278978, 201306022MIPB

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
BIBF 1120 in patients with advanced FGFR3 mutated
bibf1120 Nintedanib
BIBF1120 200 mg two times per day orally
(Experimental)
BIBF 1120 in patients with advanced FGFR3 overexpressed
bibf1120 Nintedanib
BIBF1120 200 mg two times per day orally
(Experimental)
BIBF 1120 in patients with advanced FGFR3 wild type
bibf1120 Nintedanib
BIBF1120 200 mg two times per day orally

Primary Outcomes

Measure
Response rate assessed by RECEST version 1.1
time frame: 2 months

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title 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
Principal investigator Chia-Chi Lin, Ph.D
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by National Taiwan University Hospital.