Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05567185 | A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer | PHASE1 | ACTIVE NOT_RECRUITING | 5 | — | — | Mar 3, 2023 | Aug 30, 2026 | Jun 5, 2026 | 4 | Japan |
Number of participants with DLT will be assessed. The DLTs are specific adverse events related to erdafitinib intravesical delivery system and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation: Erdafinitib Intravesical Delivery System | EXPERIMENTAL | Participants with bladder cancer and fibroblast growth factor receptor (FGFR) mutations or fusions will receive erdafitinib intravesical delivery system and study will evaluate 2 dose levels of erdafitinib. Participants with a complete response (CR) may continue to receive treatment up to a duration of 1 year as long as there is no disease recurrence or progression, intolerable toxicity or withdrawal of consent. |
| Name | Type | Description |
|---|---|---|
| Erdafitinib Intravesical Delivery System | DRUG | Erdafitinib intravesical delivery system will be administered. |
Inclusion Criteria: * Histologically confirmed non-muscle-invasive urothelial carcinoma of the bladder * All visible tumors must be completely resected prior to the start of study treatment and documented on screening cystoscopy * Confirmed recurrence of non-muscle invasive bladder cancer (NMIBC) a...