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TAR-210NCT05567185

A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer

StatusCompleted
PhasePhase 1
Primary completion
Track this trial

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Record History

All 45 versions: 14 with changes below, 31 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial completed
    • Study completion date changed from estimate of Aug 30, 2026 to Oct 31, 2025
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 4 entries
  2. Primary completion date changed from estimate of Oct 16, 2026 to Mar 11, 2025
    • Study completion date: Sep 24, 2027 to Aug 30, 2026
    v38
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 6 to 5
    • Site details revised at 4 of 4 sites
    v26
  4. Site details revised at 2 of 4 sitesv19
  5. Study completion date: Jul 30, 2027 to Sep 24, 2027v17
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites revised (4)
    • Eligibility criteria shortened, about 1 word
    v16
  2. Study completion date: Jul 31, 2027 to Jul 30, 2027v14
  3. Study completion date: Oct 16, 2026 to Jul 31, 2027v13
  4. Eligibility criteria expanded, about 73 wordsv11
  5. Study sites: 3 to 4v9
  6. Eligibility criteria expanded, about 16 wordsv6
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 4 to 3
    • Start date changed from estimate of Mar 21, 2023 to Mar 3, 2023
    v4
  8. Start date: Dec 14, 2022 to Mar 21, 2023v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Participants with Dose-limiting Toxicity (DLT)
Timeframe: Up to 28 days

Secondary (4)

Plasma Concentration of Erdafitinib
Urine Concentration of Erdafitinib
Number of Participants with Adverse Events (AEs)
Number of Participants with AEs by Severity

Arms and interventions

Dose Escalation: Erdafinitib Intravesical Delivery SystemExperimental

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.

Drugs: Erdafitinib Intravesical Delivery System

Sites

4 sites in 1 country