Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation
Фаза 3
Завершено
NCT05198934
| Заболевание | Colorectal Cancer |
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| Фаза | Фаза 3 |
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| Спонсор | Amgen |
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| Статус | Завершено |
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| Участники | 160 участн. |
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| Вмешательство | Sotorasib, Panitumumab, Trifluridine and Tipiracil, Regorafenib |
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| Дата начала | 19.04.2022 |
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| Дата завершения | 16.07.2025 |
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| Публикация результатов | 22.07.2026 |
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Кратко
The aim of the study is to compare progression-free survival (PFS) in previously treated participants with Kirsten rat sarcoma (KRAS) p.G12C mutated colorectal cancer (CRC) receiving sotorasib 240 mg once daily (QD) and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib), and sotorasib 960 mg QD and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib).
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by BICR
From randomization until DCO or death; median (min, max) time on trial was 6.23 (0.1, 14.0) months · months
| Trifluridine and Tipiracil or Regorafenib | 2.04 months |
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| Sotorasib 240 mg + Panitumumab | 3.91 months |
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| Sotorasib 960 mg + Panitumumab | 5.62 months |
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