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Active, not recruiting Phase 2 Interventional

A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer

ClinicalTrials.gov ID: NCT05154487

Public ClinicalTrials.gov record NCT05154487. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 4:56 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase 2 Study of Alpelisib and Fulvestrant for PIK3CA-mutated Estrogen Receptor (ER)-Positive Endometrioid Endometrial Cancers

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05154487
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
GOG Foundation
Network
Enrollment
51 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 11, 2024 (Actual)
Primary completion
May 1, 2028 (Estimated)
Completion
Nov 1, 2028 (Estimated)
Last update posted
Jul 30, 2026

2024 – 2028

United States locations

U.S. sites
21
U.S. states
12
U.S. cities
19
Facility City State ZIP Site status
City of Hope Duarte California 91010 —
Mount Sinai Medical Center Miami Beach Florida 33140 —
AdventHealth Gynecologic Oncology Orlando Florida 32804 —
Tampa General Hospital Tampa Florida 33606 —
Moffit Cancer Center at International Plaza Tampa Florida 33607 —
Moffitt Cancer Center Tampa Florida 33612 —
Moffit Cancer Center at Wesley Chapel Wesley Chapel Florida 33544 —
Endeavor Health Evanston Illinois 60201 —
Endeavor Health Clinical Operations, Glenbrook Hospital Glenview Illinois 60026 —
Endeavor Health Clinical Operations, Highland Park Hospital Highland Park Illinois 60035 —
Ascension St. Vincent Indianapolis Indiana 46260 —
Norton Cancer Institute Louisville Kentucky 40241 —
Johns Hopkins Medicine Baltimore Maryland 21287 —
Northwell Health Cancer Institute Lake Success New York 11042 —
QCC- Northwell Health Physicians Partners Medical Rego Park New York 11374 —
Kettering Health Cancer Center Kettering Ohio 45429 —
Oklahoma Cancer Specialists and Research Institute, LLC Tulsa Oklahoma 74146 —
Legacy Good Samaritan Medical Center Portland Oregon 97210 —
Legacy Meridian Park Medical Center Tualatin Oregon 97062 —
Legacy Salmon Creek Medical Center Vancouver Washington 98686 —
University of Wisconsin Clinical Science Center Madison Wisconsin 53792 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05154487, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 30, 2026 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05154487 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →