BIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma
NCT ID: NCT02278978
Last Updated: 2015-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
129 participants
INTERVENTIONAL
2014-10-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FGFR3 mutated
BIBF 1120 in patients with advanced FGFR3 mutated
BIBF1120
BIBF1120 200 mg two times per day orally
FGFR3 overexpressed
BIBF 1120 in patients with advanced FGFR3 overexpressed
BIBF1120
BIBF1120 200 mg two times per day orally
FGFR3 wild type
BIBF 1120 in patients with advanced FGFR3 wild type
BIBF1120
BIBF1120 200 mg two times per day orally
Interventions
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BIBF1120
BIBF1120 200 mg two times per day orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histological confirmation of urothelial carcinoma , with metastatic disease
* Measurable disease
* Previously treated with platinum-based chemotherapy administered
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Chia-Chi Lin, Ph.D
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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Chia-Chi Lin
Taipei, , Taiwan
Countries
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Other Identifiers
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201306022MIPB
Identifier Type: -
Identifier Source: org_study_id
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