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
Phase 2
Terminated
NCT05082025
| Condition | Endometrial Cancer, Ovarian Cancer |
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| Phase | Phase 2 |
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| Sponsor | M.D. Anderson Cancer Center |
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| Status | Terminated |
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| Enrollment | 7 participants |
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| Interventions | Copanlisib, fulvestrant |
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| Start date | Sep 27, 2022 |
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| Completion date | May 3, 2024 |
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| Results posted | Jul 11, 2025 |
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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.
Dose Limiting Toxicity (DLT)
Within the first cycle (28-days) of treatment. · Participants
| Part 1: Dose Confirmation - Dose Level 1 | 0 Participants |
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Number of Participants With Treatment-related Adverse Events
Through study completion, an average of 14 weeks. · Participants
| Part 1: Dose Confirmation - Dose Level 1 | 3 Participants |
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| Part 1: Dose Confirmation - Dose Level 1 | 3 Participants |
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| Part 1: Dose Confirmation - Dose Level 1 | 2 Participants |
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| Part 1: Dose Confirmation - Dose Level 1 | 3 Participants |
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| Part 1: Dose Confirmation - Dose Level 1 | 1 Participants |
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| Part 1: Dose Confirmation - Dose Level 1 | 1 Participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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