Clinical trial · Interventional
BIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma
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
NCT02278978CI-TRIAL-00017867unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIBF1120 | Drug | Nintedanib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- FGFR3 mutated
- description
- BIBF 1120 in patients with advanced FGFR3 mutated
- interventionNames
- Drug: BIBF1120
- type
- EXPERIMENTAL
- label
- FGFR3 overexpressed
- description
- BIBF 1120 in patients with advanced FGFR3 overexpressed
- interventionNames
- Drug: BIBF1120
- type
- EXPERIMENTAL
- label
- FGFR3 wild type
- description
- BIBF 1120 in patients with advanced FGFR3 wild type
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMatin SF, Adibi M, Shah AY, Alhalabi O, Corn P, Guo C, Amirtharaj R, Xiao L, Lange S, Duose DY, Wang S, Pal S, Campbell MT. Phase 1b Trial Evaluating Tolerability and Activity of Targeted Fibroblast Growth Factor Receptor Inhibition in Localized Upper Tract Urothelial Carcinoma. J Urol. 2024 Jun;211(6):784-793. doi: 10.1097/JU.0000000000003928. Epub 2024 Apr 4. PMID 38573872