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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 May 2015 |
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Main ID: |
NCT02278978 |
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Date of registration:
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28/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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BIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma
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Scientific title:
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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 |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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129 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02278978 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Chia-Chi Lin, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Taiwan University Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Urothelial Carcinoma
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Intervention(s)
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Drug: BIBF1120
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Primary Outcome(s)
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Response rate assessed by RECEST version 1.1
[Time Frame: 2 months]
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Secondary ID(s)
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201306022MIPB
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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