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NCT05154487 · ClinicalTrials.gov registry record · Phase 2
A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer
A Phase 2 study of Endometroid Endometrial Cancer, sponsored by GOG Foundation.
- Active
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 18
- Study locations
NCT05154487: Active Phase 2 study of Endometroid Endometrial Cancer, sponsored by GOG Foundation.
NCT05154487 is a Phase 2 study of Endometroid Endometrial Cancer that is active but no longer recruiting, run by GOG Foundation. The registered enrollment target is 51 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). The trial reports 18 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05154487, a Phase 2 study of Endometroid Endometrial Cancer, is active but no longer recruiting, sponsored by GOG Foundation.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 18
- Study locations
Study Summary
This is a 2 stage multi-center study designed to evaluate the efficacy of the combination of alpelisib and fulvestrant in patients with PIK3CA-mutated ER-positive endometrioid endometrial cancers by estimating the objective response rate (ORR). Treatment will continue until either unacceptable toxicity, progression of disease, or investigator/patient request for withdrawal.
Primary Outcome
To determine the objective response rate of the combination of alpelisib and fulvestrant in patients with advanced, persistent or recurrent PIK3CA-mutated ER-positive endometrioid endometrial cancer. Respnse criteria based on RECIST Version 1.1 (complete or partial response).
Conditions Studied
Interventions
- DRUG Fulvestrant injection
- DRUG Alpelisib Pill
Study Locations (18)
Florida
- Mount Sinai Medical Center - Miami Beach
- AdventHealth Gynecologic Oncology - Orlando
- Tampa General Hospital - Tampa
- Moffit Cancer Center at International Plaza - Tampa
- Moffitt Cancer Center - Tampa
- Moffit Cancer Center at Wesley Chapel - Wesley Chapel
New York
- Northwell Health Cancer Institute - Lake Success
- QCC- Northwell Health Physicians Partners Medical - Rego Park
Oregon
- Legacy Good Samaritan Medical Center - Portland
- Legacy Meridian Park Medical Center - Tualatin
California
- City of Hope - Duarte
Indiana
- Ascension St. Vincent - Indianapolis
Kentucky
- Norton Cancer Institute - Louisville
Maryland
- Johns Hopkins Medicine - Baltimore
Ohio
- Kettering Health Cancer Center - Kettering
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2024-09-11 |
| Est. Completion | 2028-11-01 |
| Phase | Phase 2 |
What the registry record for NCT05154487 still lists
NCT05154487 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Endometroid Endometrial Cancer appearing as the primary indexed condition, and to 2 interventions - of which Fulvestrant injection is the first listed.
NCT05154487 lists 18 locations in 11 states (Florida, New York, Oregon).
Frequently Asked Questions
What is clinical trial NCT05154487 about?
NCT05154487 is a clinical study titled "A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer". This is a 2 stage multi-center study designed to evaluate the efficacy of the combination of alpelisib and fulvestrant in patients with PIK3CA-mutated ER-positive endometrioid endometrial cancers by estimating the objective response rate (ORR). Treatment will continue until either unacceptable toxic...
What is the current status of trial NCT05154487?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2024-09-11. Estimated completion is 2028-11-01.
What conditions does trial NCT05154487 study?
This clinical trial studies the following conditions: Endometroid Endometrial Cancer.
What interventions are being tested in trial NCT05154487?
The interventions under investigation include: Fulvestrant injection (DRUG), Alpelisib Pill (DRUG).
Who is sponsoring clinical trial NCT05154487?
This trial is sponsored by GOG Foundation, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05154487 being conducted?
This trial has 18 study locations across California, Florida, Indiana, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05154487's enrollment target sits among peer trials
51 1190th of 2000 higher than 806 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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