drugset / Trial / NCT05082025
Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations
RandomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of copanlisib in combination with fulvestrant in advanced hormone receptor-positive (HR+) solid tumors harboring alterations that activate the Phosphatidylinositol-3 kinase (PI3K) pathway.
Timeline
- Start
- 2022-09-27
- Primary completion
- 2024-05-03
- Completion
- 2025-12-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Copanlisib | Small molecule | 60 mg | Intravenous |
| Subject | Fulvestrant | Small molecule | 500 mg | Intramuscular |