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NCT04228042 · ClinicalTrials.gov registry record · Phase 1
Infigratinib Before Surgery for the Treatment of Upper Tract Urothelial Cancer
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT04228042: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT04228042 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04228042, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This phase Ib trial studies the side effects of infigratinib before surgery in treating patients with upper tract urothelial cancer. Infigratinib may stop the growth of tumor cells by blocking the activities of a gene called FGFR needed for cell growth. Giving infigratinib before surgery may cause the tumor to shrink, which may make the surgical procedure easier and/or reduce the need for more extensive surgery.
Primary Outcome
The study will estimate percentage of patients who are not able to complete treatment (discontinuation) due to excessive toxicity along with the 90% exact confidence interval (NOTE: excessive toxicity is defined as treatment related adverse events that cause patients not to complete 2-cycles of planned treatment schedule, or delay in planned surgery greater than 14 days)
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- PROCEDURE Surgical Procedure
- DRUG Infigratinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2020-07-28 |
| Est. Completion | 2024-04-17 |
| Phase | Phase 1 |
Why NCT04228042 stopped before completion
NCT04228042 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04228042 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04228042 about?
NCT04228042 is a clinical study titled "Infigratinib Before Surgery for the Treatment of Upper Tract Urothelial Cancer". This phase Ib trial studies the side effects of infigratinib before surgery in treating patients with upper tract urothelial cancer. Infigratinib may stop the growth of tumor cells by blocking the activities of a gene called FGFR needed for cell growth. Giving infigratinib before surgery may cause t...
What is the current status of trial NCT04228042?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2020-07-28. Estimated completion is 2024-04-17.
What interventions are being tested in trial NCT04228042?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Surgical Procedure (PROCEDURE), Infigratinib (DRUG).
Who is sponsoring clinical trial NCT04228042?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04228042's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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