drugset / Trial / NCT05154487
A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpelisib | Small molecule | 300 mg | Oral |
| Subject | Fulvestrant | Small molecule | 500 mg | Intramuscular |