Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, With a Specific Focus on Patients With Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer
Phase 1
Active, not recruiting
NCT04514497
| Condition | Metastatic Lung Small Cell Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic Neuroendocrine Carcinoma, Metastatic Pancreatic Adenocarcinoma |
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| Phase | Phase 1 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 29 participants |
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| Interventions | Biopsy Procedure, Biospecimen Collection, Computed Tomography, Elimusertib, Irinotecan Hydrochloride |
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| Start date | Oct 20, 2021 |
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| Completion date | Feb 15, 2025 |
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| Results posted | May 19, 2026 |
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Summary
This phase I trial tests the safety, side effects and best dose of BAY 1895344 when given together with usual chemotherapy (irinotecan or topotecan) in treating patients with solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), with a specific focus on small cell lung cancer, poorly differentiated neuroendocrine cancer, and pancreatic cancer. BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as irinotecan and topotecan, 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. Adding BAY 1895344 to irinotecan or topotecan may be safe and tolerable in treating patients with advanced solid tumors.
Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Elimursertib
Up to 21 days (first treatment cycle) · mg
| Cohort I (Elimusertib, Irinotecan) | 10 mg |
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| Cohort II (Elimusertib, Irinotecan) | 20 mg |
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| Cohort III (Elimusertib, Topotecan) | 20 mg |
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Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Irinotecan
Up to 21 days (first treatment cycle) · mg/m^2
| Cohort I (Elimusertib, Irinotecan) | 150 mg/m^2 |
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| Cohort II (Elimusertib, Irinotecan) | 25 mg/m^2 |
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Maximum Tolerated Dose (MTD) (Dose Escalation Phase) of Topotecan
Up to 21 days (first treatment cycle) · mg/m^2
| Cohort III (Elimusertib, Topotecan) | 1 mg/m^2 |
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Open in BENITIONS
View on ClinicalTrials.gov
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