Carboplatin, Gemcitabine Hydrochloride, and Berzosertib in Treating Patients With Recurrent and Metastatic Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
1期
进行中(已停止招募)
NCT02627443
| 适应症 | Metastatic Fallopian Tube Carcinoma, Metastatic Ovarian Carcinoma, Metastatic Primary Peritoneal Carcinoma, Ovarian Endometrioid Tumor |
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| 分期 | 1期 |
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| 申办方 | National Cancer Institute (NCI) |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 35 人 |
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| 干预(药物) | Berzosertib, Carboplatin, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study |
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| 开始日期 | 2017年5月16日 |
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| 完成日期 | 2024年10月4日 |
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| 结果公布日 | 2026年4月2日 |
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摘要
This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and berzosertib when given together with carboplatin in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent) and has spread to other places in the body (metastatic). Chemotherapy drugs, such as carboplatin and gemcitabine hydrochloride, 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. Berzosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving berzosertib with chemotherapy (carboplatin and gemcitabine hydrochloride) may work better in treating patients with ovarian, primary peritoneal, or fallopian tube cancer compared to chemotherapy alone.
Dost Limiting Toxicity (DLT) (Phase I Dose Escalation)
Up to 28 days · Participants
| Dose Level 1 | 1 Participants |
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| Dose Level 2 | 2 Participants |
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Incidence of Adverse Events
Up to 3 years · Participants
| Dose Level 1 | 28 Participants |
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| Dose Level 2 | 5 Participants |
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| Dose Level 1 | 18 Participants |
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| Dose Level 2 | 4 Participants |
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| Dose Level 1 | 0 Participants |
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| Dose Level 2 | 0 Participants |
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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。