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ACTIVE NOT RECRUITING Phase 2

A Study of Oral Erdafitinib in People With Recurrent Non-Invasive Bladder Cancer

NCT04917809 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 20 participants
Start Date 2022-02-17
Est. Completion 2026-08
Phase Phase 2

Sponsor

Memorial Sloan Kettering Cancer Center

2,280 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04917809

The ClinicalTrials.gov registry entry for NCT04917809 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 2,280 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04917809 reports 7 study locations spanning 2 distinct geographic areas — top geographies include New York, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04917809?

The interventions under investigation include: Erdafitinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04917809?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 2,280 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial