Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs
2상
진행 중(모집 완료)
NCT03896503
| 대상 질환 | Extensive Stage Lung Small Cell Carcinoma, Extrapulmonary Small Cell Neuroendocrine Carcinoma, Limited Stage Lung Small Cell Carcinoma, Platinum-Resistant Lung Small Cell Carcinoma |
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| 임상 단계 | 2상 |
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| 스폰서 | National Cancer Institute (NCI) |
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| 상태 | 진행 중(모집 완료) |
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| 참여자 수 | 104 명 |
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| 중재(약물) | Berzosertib, Biopsy Procedure, Biospecimen Collection, Computed Tomography, Topotecan Hydrochloride |
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| 시작일 | 2019년 12월 30일 |
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| 완료일 | 2022년 12월 19일 |
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| 결과 공개일 | 2024년 11월 13일 |
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요약
This phase II trial studies how well berzosertib (M6620) works when given in combination with topotecan hydrochloride (topotecan) compared with topotecan alone in treating patients with small cell lung cancer that has come back (relapsed), or small cell cancer that arises from a site other than the lung (extrapulmonary). Drugs used in chemotherapy, such as topotecan hydrochloride, work by damaging the DNA (deoxyribonucleic acid) in tumor cells, causing those cells to die and the tumor to shrink. However, some tumor cells can become less affected by chemotherapy because they have ways to repair the damaged DNA. The addition of M6620 could help topotecan hydrochloride shrink the cancer and prevent it from returning by blocking enzymes needed for DNA repair.
Progression-free Survival (PFS) Reported With 80% Confidence Interval
From start of treatment to time of progression or death, whichever occurs first, assessed at 6 months after last participant has enrolled; up to 2 years for pulmonary cohort and up 31.5 months for Exploratory Cohort. · Months
| Platinum Response - Sensitive: Topotecan Monotherapy | 5.5 Months |
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| Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy | 4.4 Months |
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| Platinum Response - Resistant: Topotecan Monotherapy | 2.1 Months |
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| Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy | 2.7 Months |
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| Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy | 1.5 Months |
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Progression-free Survival (PFS) Reported With 95% Confidence Interval
From start of treatment to time of progression or death, whichever occurs first, assessed at 6 months after last participant has enrolled; up to 2 years for pulmonary cohort and up 31.5 months for Exploratory Cohort. · Months
| Platinum Response - Sensitive: Topotecan Monotherapy | 5.5 Months |
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| Platinum Response - Sensitive: Topotecan & M6620 (VX-970) Combination Therapy | 4.4 Months |
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| Platinum Response - Resistant: Topotecan Monotherapy | 2.1 Months |
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| Platinum Response - Resistant: Topotecan & M6620 (VX-970) Combination Therapy | 2.7 Months |
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| Exploratory Cohort: Topotecan & M6620 (VX-970) Combination Therapy | 1.5 Months |
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