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NCT04917809 · ClinicalTrials.gov registry record · Phase 2
A Study of Oral Erdafitinib in People With Recurrent Non-Invasive Bladder Cancer
A Phase 2 study of Bladder Cancer and Recurrent Bladder Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 7
- Study locations
NCT04917809: Active Phase 2 study of Bladder Cancer and Recurrent Bladder Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT04917809 is a Phase 2 study of Bladder Cancer and Recurrent Bladder Cancer that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 20 participants, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04917809, a Phase 2 study of Bladder Cancer and Recurrent Bladder Cancer, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to assess the effectiveness of erdafitinib in people with non-muscle invasive bladder cancer (NMIBC) that has come back after standard treatment, such as Bacillus Calmette-Guerin (BCG) or chemotherapy instilled into the bladder. Participants in this study will have bladder cancer with a mutation in the FGFR3 gene. FGFR3 mutations are the most common genetic alteration in NMIBC and is present in the majority of recurrent NMIBC tumors. Genetic testing of the participant's prior or recurrent NMIBC tumor will be performed to confirm it has an FGFR3 gene mutation. Erdafitinib is a pill given orally (by mouth) that blocks the protein made by this altered gene, which may stop cancer cells from growing. Erdafitinib is already used as an approved treatment for metastatic bladder cancer. Researchers are doing this study to determine whether erdafitinib is an effective treatment for FGFR3-altered non-muscle invasive bladder cancer in the time period between when a recurrent tumor is identified and a TURBT (transurethral resection of a bladder tumor) or biopsy procedure is performed to remove it.
Primary Outcome
The primary endpoint of this trial is the objective response rate at the time of TURBT/biopsy (defined as the proportion of patients achieving a complete or partial pathologic response by cytologic examination, cystoscopic examination, and biopsy) following treatment with erdafitinib. A complete response is defined as the absence of tumor on TURBT/biopsy, with a negative urinary cytologic result; a partial response is defined as a decrease of at least 50% in the size of the target tumor(s), on t
Conditions Studied
Interventions
- DRUG Erdafitinib
Study Locations (7)
New York
- Memorial Sloan Kettering Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-02-17 |
| Est. Completion | 2026-08 |
| Phase | Phase 2 |
What the registry record for NCT04917809 still lists
NCT04917809 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 1 intervention - of which Erdafitinib is the first listed.
NCT04917809 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT04917809 about?
NCT04917809 is a clinical study titled "A Study of Oral Erdafitinib in People With Recurrent Non-Invasive Bladder Cancer". The purpose of this study is to assess the effectiveness of erdafitinib in people with non-muscle invasive bladder cancer (NMIBC) that has come back after standard treatment, such as Bacillus Calmette-Guerin (BCG) or chemotherapy instilled into the bladder. Participants in this study will have bladd...
What is the current status of trial NCT04917809?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2022-02-17. Estimated completion is 2026-08.
What conditions does trial NCT04917809 study?
This clinical trial studies the following conditions: Bladder Cancer, Recurrent Bladder Cancer, FGFR3 Gene Mutation.
What interventions are being tested in trial NCT04917809?
The interventions under investigation include: Erdafitinib (DRUG).
Who is sponsoring clinical trial NCT04917809?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04917809 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04917809's enrollment target sits among peer trials
20 149th of 175 higher than 22 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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