Trials / Active Not Recruiting
Active Not RecruitingNCT05154487
A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer
Phase 2 Study of Alpelisib and Fulvestrant for PIK3CA-mutated Estrogen Receptor (ER)-Positive Endometrioid Endometrial Cancers
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 51 (estimated)
- Sponsor
- GOG Foundation · Network
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Alpelisib Pill | Kinase inhibitor |
| DRUG | Fulvestrant injection | estrogen receptor agonist |
Timeline
- Start date
- 2024-09-11
- Primary completion
- 2028-05-01
- Completion
- 2028-11-01
- First posted
- 2021-12-13
- Last updated
- 2026-03-03
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05154487. Inclusion in this directory is not an endorsement.