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
Фаза 2
Прекращено
NCT05082025
| Заболевание | Endometrial Cancer, Ovarian Cancer |
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| Фаза | Фаза 2 |
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| Спонсор | M.D. Anderson Cancer Center |
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| Статус | Прекращено |
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| Участники | 7 участн. |
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| Вмешательство | Copanlisib, fulvestrant |
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| Дата начала | 27.09.2022 |
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| Дата завершения | 3.05.2024 |
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| Публикация результатов | 11.07.2025 |
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Кратко
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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