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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 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. The trial reports 18 study locations across 11 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05154487
The ClinicalTrials.gov registry entry for NCT05154487 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GOG Foundation, which has 14 total studies on file at ClinicalTrials.gov.
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 reports 18 study locations spanning 11 distinct geographic areas - top geographies include 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.
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