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NCT04197986 · ClinicalTrials.gov registry record · Phase 3
Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations
A Phase 3 study, sponsored by QED Therapeutics, a BridgeBio company.
- Terminated
- Registry status
- Phase 3
- Development phase
- 39
- Enrollment target
NCT04197986: Clinical Trial Phase 3 study, sponsored by QED Therapeutics, a BridgeBio company.
NCT04197986 is a Phase 3 study that was terminated before completion, run by QED Therapeutics, a BridgeBio company. The registered enrollment target is 39 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04197986, a Phase 3 study, was terminated before completion, sponsored by QED Therapeutics, a BridgeBio company.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 39 participants
- Enrollment target
Study Summary
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of infigratinib (an oral targeted FGFR1-3 inhibitor) versus placebo, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or rearrangements) who have disease that is considered at high risk for recurrence with surgery alone. The study enrolls subjects with either bladder cancer post radical cystectomy or upper tract urothelial cancer post distal ureterectomy and/or nephrectomy. Study treatment is randomized 1:1 between infigratinib or placebo with treatment up to 1 year or until invasive local, distal, or metastatic disease recurrence confirmed by independent imaging reviewer.
Primary Outcome
DFS was defined as the number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause (referred as DFS event), whichever occurs earlier. Due to early termination of the study by the sponsor, results will focus primarily on the primary and key secondary endpoints of the study. Due to early termination of the study by the sponsor, data were censored for 85.0% to 89.5% of all subjects. Data cutoff 28 Feb 2023.
Interventions
- DRUG Placebo
- DRUG Infigratinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2020-03-11 |
| Est. Completion | 2023-02-28 |
| Phase | Phase 3 |
Why NCT04197986 stopped before completion
NCT04197986 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04197986 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04197986 about?
NCT04197986 is a clinical study titled "Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations". This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of infigratinib (an oral targeted FGFR1-3 inhibitor) versus placebo, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic a...
What is the current status of trial NCT04197986?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 39 participants. The study started on 2020-03-11. Estimated completion is 2023-02-28.
What interventions are being tested in trial NCT04197986?
The interventions under investigation include: Placebo (DRUG), Infigratinib (DRUG).
Who is sponsoring clinical trial NCT04197986?
This trial is sponsored by QED Therapeutics, a BridgeBio company, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04197986's enrollment target sits among peer trials
39 1898th of 2000 higher than 101 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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