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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 is a Phase 3 study that was terminated before completion, run by QED Therapeutics, a BridgeBio company. The registered enrollment target is 39 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04197986
The ClinicalTrials.gov registry entry for NCT04197986 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is QED Therapeutics, a BridgeBio company, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04197986 reports 0 study locations.
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.
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