drugset / Trial / NCT05154487

A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer

NCT05154487

Phase 2 Active not recruiting 51 enrolled GOG Foundation Novartis · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-09-11
Primary completion
2028-05-01
Completion
2028-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Alpelisib Small molecule 300 mg Oral
Subject Fulvestrant Small molecule 500 mg Intramuscular