Clinical trial · Interventional
Phase II Study of TKI258 in Advanced Urothelial Carcinoma
A Phase II Multi-center, Non-randomized, Open Label Study of TKI258 in FGFR3 Mutated and FGFR3 Wild Type Advanced Urothelial Carcinoma
NCT00790426CI-TRIAL-00048965completedPhase 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)
This study will evaluate the efficacy of TKI258 in patients with advanced urothelial cancer
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 Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TKI258 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FGFR3 wild type
- interventionNames
- Drug: TKI258
- type
- EXPERIMENTAL
- label
- FGFR3 mutant
- interventionNames
- Drug: TKI258
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- 4 months
Secondary outcomes (3)
- measure
- Disease control rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with transitional cell cancer of the bladder, urethra, ureter, or renal pelvis * Patients who have archival tumor tissue available for FGFR3 mutational status screening * Patients with progressive disease * Patients with measurable disease by RECIST * Patients previously treated with at least 1 but not more than 3 systemic cytotoxic regimens with at least one of these regimens including at least one of the following: cisplatin, carboplatin, gemcitabine or taxane administered in the perioperative or advanced setting * Age ≥ 18 years * WHO Performance Status ≤ 2 * Patients willing and able to take oral medication, follow scheduled visits, treatment plan and laboratory tests * Patients with signed and witnessed informed consent form * Patients with adequate organ function Exclusion Criteria: * Patients with brain cancer * Patients with other cancers except for certain skin, cervical \& prostate cancers * Patients who have not recovered from previous cancer treatment * Patients who have severe and/or uncontrolled medical conditions which could affect participation in the study Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (1)
- DERIVEDMilowsky MI, Dittrich C, Duran I, Jagdev S, Millard FE, Sweeney CJ, Bajorin D, Cerbone L, Quinn DI, Stadler WM, Rosenberg JE, Lochheed M, Sen P, Squires M, Shi M, Sternberg CN. Phase 2 trial of dovitinib in patients with progressive FGFR3-mutated or FGFR3 wild-type advanced urothelial carcinoma. Eur J Cancer. 2014 Dec;50(18):3145-52. doi: 10.1016/j.ejca.2014.10.013. Epub 2014 Oct 30. PMID 25457633