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A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer

NCT05154487 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2026-03-03

No results posted yet for this 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

  • Endometroid Endometrial Cancer

Interventions

DRUG

Alpelisib Pill

Kinase inhibitor

DRUG

Fulvestrant injection

estrogen receptor agonist

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • GOG Foundation

    lead NETWORK

Principal Investigators

  • Stephanie Gaillard, MD · GOG Foundation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-11
Primary Completion
2028-05-01
Completion
2028-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05154487 on ClinicalTrials.gov