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NCT04393285 · ClinicalTrials.gov registry record · Phase 2
Abemaciclib and Letrozole to Treat Endometrial Cancer
A Phase 2 study of Endometrial Cancer, sponsored by Gynecologic Oncology Group.
- Active
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
- 20
- Study locations
NCT04393285: Active Phase 2 study of Endometrial Cancer, sponsored by Gynecologic Oncology Group.
NCT04393285 is a Phase 2 study of Endometrial Cancer that is active but no longer recruiting, run by Gynecologic Oncology Group. The registered enrollment target is 53 participants, below the 524-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04393285, a Phase 2 study of Endometrial Cancer, is active but no longer recruiting, sponsored by Gynecologic Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a phase II single arm trial to determine the percentage of patients without evidence of disease progression on abemaciclib and letrozole in advanced stage, persistent or recurrent endometrioid endometrial cancer at 6 months. Treatment will continue until either unacceptable toxicity, progression of disease, or investigator/patient request for withdrawal.
Primary Outcome
To evaluate the efficacy in terms of the probability of surviving progression free for at least 6 months (PFS at 6 mo)
Conditions Studied
Interventions
- DRUG Letrozole
- DRUG Abemaciclib
Study Locations (20)
Florida
- Sylvester Comprehensive Cancer Center-Lennar Foundation Medical Center - Coral Gables
- Sylevester Comprehensive Cancer Center-Deerfield Beach - Deerfield Beach
- UF Health Cancer Center - Gainesville
- University of Miami - Sylvester Cancer Center - Miami
- UT Health Tower - Miami
- Advent Health - Orlando - Orlando
- Sylvester Comprehensive Cancer Center-Plantation - Plantation
- Cleveland Clinic Florida - Weston
Connecticut
- Smillow Cancer Care at Greenwich - Greenwich
- Yale University - New Haven
Massachusetts
- Tufts Medical Center - Boston
- University of Massachusetts - Worcester
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
- Holy Name Medical Center - Teaneck
Alabama
- University of South Alabama Mitchell Cancer Center - Mobile
Alaska
- Alaska Women's Cancer Care - Anchorage
Georgia
- Lewis Cancer & Research Pavilion - Savannah
Illinois
- University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2020-10-10 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04393285 still lists
NCT04393285 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 524-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Endometrial Cancer appearing as the primary indexed condition, and to 2 interventions - of which Letrozole is the first listed.
NCT04393285 names 20 study sites across 10 states, led by Florida, Connecticut, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04393285 about?
NCT04393285 is a clinical study titled "Abemaciclib and Letrozole to Treat Endometrial Cancer". This is a phase II single arm trial to determine the percentage of patients without evidence of disease progression on abemaciclib and letrozole in advanced stage, persistent or recurrent endometrioid endometrial cancer at 6 months. Treatment will continue until either unacceptable toxicity, progres...
What is the current status of trial NCT04393285?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2020-10-10. Estimated completion is 2026-12-31.
What conditions does trial NCT04393285 study?
This clinical trial studies the following conditions: Endometrial Cancer.
What interventions are being tested in trial NCT04393285?
The interventions under investigation include: Letrozole (DRUG), Abemaciclib (DRUG).
Who is sponsoring clinical trial NCT04393285?
This trial is sponsored by Gynecologic Oncology Group, which has 154 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04393285 being conducted?
This trial has 20 study locations across Alabama, Alaska, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Endometrial Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04393285's enrollment target sits among peer trials
53 122nd of 181 higher than 59 of 181 other Endometrial Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometrial Cancer 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.
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