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
2期
提前终止
NCT05082025
| 适应症 | Endometrial Cancer, Ovarian Cancer |
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| 分期 | 2期 |
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| 申办方 | M.D. Anderson Cancer Center |
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| 状态 | 提前终止 |
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| 受试者人数 | 7 人 |
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| 干预（药物） | Copanlisib, fulvestrant |
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| 开始日期 | 2022年9月27日 |
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| 完成日期 | 2024年5月3日 |
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| 结果公布日 | 2025年7月11日 |
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摘要
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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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。