Back to resultsBIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma
Primary Purpose
Urothelial Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
BIBF1120
Sponsored by
About this trial
This is an interventional treatment trial for Urothelial Carcinoma focused on measuring urothelial carcinoma, BIBF1120
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
Sites / Locations
- Chia-Chi Lin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
FGFR3 mutated
FGFR3 overexpressed
FGFR3 wild type
Arm Description
BIBF 1120 in patients with advanced FGFR3 mutated
BIBF 1120 in patients with advanced FGFR3 overexpressed
BIBF 1120 in patients with advanced FGFR3 wild type
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02278978
First Posted
October 28, 2014
Last Updated
May 10, 2015
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02278978
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Carcinoma
Keywords
urothelial carcinoma, BIBF1120
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
129 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FGFR3 mutated
Arm Type
Experimental
Arm Description
BIBF 1120 in patients with advanced FGFR3 mutated
Arm Title
FGFR3 overexpressed
Arm Type
Experimental
Arm Description
BIBF 1120 in patients with advanced FGFR3 overexpressed
Arm Title
FGFR3 wild type
Arm Type
Experimental
Arm Description
BIBF 1120 in patients with advanced FGFR3 wild type
Intervention Type
Drug
Intervention Name(s)
BIBF1120
Other Intervention Name(s)
Nintedanib
Intervention Description
BIBF1120 200 mg two times per day orally
Primary Outcome Measure Information:
Title
Response rate assessed by RECEST version 1.1
Description
To define the response rate of BIBF1120 in patients with advanced FGFR3-mutated,overexpressed,wild type UC and who have failed platinum-based chemotherapy.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Chi Lin, Ph.D
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chia-Chi Lin
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
BIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma
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