Brief Title
BIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Response rate assessed by RECEST version 1.1
Condition
Urothelial Carcinoma
Intervention
BIBF1120
Study Arms / Comparison Groups
FGFR3 mutated
Description: BIBF 1120 in patients with advanced FGFR3 mutated
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
129
Start Date
October 2014
Completion Date
March 2016
Primary Completion Date
December 2015
Eligibility 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
Gender
All
Ages
20 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Chia-Chi Lin, Ph.D, ,
Location Countries
Taiwan
Location Countries
Taiwan
Administrative Informations
NCT ID
NCT02278978
Organization ID
201306022MIPB
Responsible Party
Sponsor
Study Sponsor
National Taiwan University Hospital
Study Sponsor
Chia-Chi Lin, Ph.D, Principal Investigator, National Taiwan University Hospital
Verification Date
May 2015