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NCT04527991 · ClinicalTrials.gov registry record · Phase 3
Study of Sacituzumab Govitecan Versus Physician's Choice of Treatment in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 711
- Enrollment target
NCT04527991: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT04527991 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 711 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04527991, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 711 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician's choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC).
Primary Outcome
OS was defined as time from the date of randomization to the date of death, regardless of cause. Kaplan-Meier (KM) estimates were used for analysis.
Interventions
- DRUG Docetaxel
- DRUG Paclitaxel
- DRUG Sacituzumab Govitecan-hziy
- DRUG Vinflunine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 711 participants |
| Start Date | 2021-01-13 |
| Est. Completion | 2025-07-04 |
| Phase | Phase 3 |
What the finished NCT04527991 record still lists
NCT04527991 is an interventional study that assigns participants to a tested intervention. The registered 711 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Docetaxel is the first listed.
NCT04527991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04527991 about?
NCT04527991 is a clinical study titled "Study of Sacituzumab Govitecan Versus Physician's Choice of Treatment in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread". The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician's choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC).
What is the current status of trial NCT04527991?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 711 participants. The study started on 2021-01-13. Estimated completion is 2025-07-04.
What interventions are being tested in trial NCT04527991?
The interventions under investigation include: Docetaxel (DRUG), Paclitaxel (DRUG), Sacituzumab Govitecan-hziy (DRUG), Vinflunine (DRUG).
Who is sponsoring clinical trial NCT04527991?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04527991's enrollment target sits among peer trials
711 501st of 2000 higher than 1,499 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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