Testing the Addition of an Anticancer Drug, BAY 1895344, to the Usual Chemotherapy With FOLFIRI in Advanced or Metastatic Cancers of the Stomach and Intestines
1상
진행 중(모집 완료)
NCT04535401
| 대상 질환 | Advanced Colorectal Carcinoma, Advanced Digestive System Carcinoma, Advanced Gastric Carcinoma, Advanced Gastroesophageal Junction Adenocarcinoma |
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| 임상 단계 | 1상 |
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| 스폰서 | National Cancer Institute (NCI) |
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| 상태 | 진행 중(모집 완료) |
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| 참여자 수 | 10 명 |
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| 중재(약물) | Biopsy, Biospecimen Collection, Diagnostic Imaging, Elimusertib, Fluorouracil |
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| 시작일 | 2021년 8월 13일 |
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| 완료일 | 2025년 2월 19일 |
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| 결과 공개일 | 2026년 7월 13일 |
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요약
This phase I trial investigates the best dose, possible benefits and/or side effects of BAY 1895344 in combination with FOLFIRI in treating patients with stomach or intestinal cancer that that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or has spread from where it first started (primary site) to other places in the body (metastatic). BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as irinotecan, fluorouracil, and leucovorin, (called FOLFIRI in short) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving BAY 1895344 in combination with FOLFIRI may help shrink advanced or metastatic stomach and/or intestinal cancer.
Maximum Tolerated Dose (MTD) of Elimusertib (BAY 1895344) in Combination With Irinotecan, Fluorouracil, and Leucovorin (FOLFIRI)
Up to 28 days · mg/m2
| Elimusertib + Irinotecan + Fluorouracil + Leucovorin (FOLFIRI) | NA mg/m2 |
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Patients Who Experienced DLTs
Up to 28 days · percentage of patients
| Treatment (Elimusertib, FOLFIRI): DL-1 | 33.3 percentage of patients |
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| Treatment (Elimusertib, FOLFIRI): DL-1B | 66.7 percentage of patients |
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| Treatment (Elimusertib, FOLFIRI): DL1 | 33.3 percentage of patients |
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| Treatment (Elimusertib, FOLFIRI): DL1B | 100 percentage of patients |
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