Clinical trial · Observational
Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor request to terminate study due to enrollment numbers
Summary
Brief summary (as posted)
Bladder cancers are associated with genetic mutations that are present in the patient's bladder or urothelium, the lining of the lower urinary tract. Fibroblast growth factor (FGFR) alterations are present in approximately one in five patients with recurrent and refractory bladder cancer. This study will collect biomarker data from subjects receiving erdafitinib to further investigate the relationship between treatment with erdafitinib and clinical response, progression, and/or genetic alterations.
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Bladder Urothelial Carcinoma | Bladder Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
| FGFR2 Amplification | — | UNRESOLVED | — |
| FGFR2 Gene Mutation | — | UNRESOLVED | — |
| FGFR3 Gene Mutation | — | UNRESOLVED | — |
| FGFR Mutation | — | UNRESOLVED | — |
| Locally Advanced Urothelial Carcinoma | Urothelial Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Urothelial Carcinoma | Urothelial Carcinoma | CURATED_BROADER | 0.78 |
| Platinum-Resistant Urothelial Carcinoma | Platinum-Resistant Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Balversa | Drug | Erdafitinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Relationship between treatment with erdafitinib and clinical response
- timeFrame
- Time to progression will vary for each patient. We expect most patients to progress on erdafitinib within 2 to 15 months from baseline
- description
- Specimen collection will be performed at the following timepoints to assess clinical response while being treated with erdafitinib: 1. Baseline (prior to or within 7 days of starting erdafitinib) 2. Suspicion of progression (optional) 3. Post-progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with a diagnosis of locally advanced or metastatic bladder cancer * Documented proof of an FGFR alteration according to a CLIA-based test * Subjects who are receiving or will receive erdafitinib as their standard medical therapy as a monotherapy or in combination * Age greater than or equal to 18 years. * Subject is a resident of or seeking care in the United States * Able and willing to provide informed consent to this biomarker study * Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088). Exclusion Criteria: * Subjects younger than 18 years of age * Subjects unwilling or unable to provide informed consent * Subjects that are not receiving treatment in the United States or US Territories
References
Publications (1)
- BACKGROUNDFacchinetti F, Hollebecque A, Bahleda R, Loriot Y, Olaussen KA, Massard C, Friboulet L. Facts and New Hopes on Selective FGFR Inhibitors in Solid Tumors. Clin Cancer Res. 2020 Feb 15;26(4):764-774. doi: 10.1158/1078-0432.CCR-19-2035. Epub 2019 Oct 4. PMID 31585937