Clinical Trial

A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer

Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 1 change
minor Trial sites expanded: 18 -> 21 locations 2026-07-31
Trial Details
NCT Number NCT05154487
Lead Sponsor GOG Foundation
Collaborators: Novartis
Conditions Endometroid Endometrial Cancer
Enrollment 51 participants
Start Date 2024-09-11
Primary Completion 2028-05-01 (estimated)
Study Completion 2028-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-30