Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer
第1/2相
実施中(募集終了)
NCT01012817
| 対象疾患 | Metastatic Malignant Solid Neoplasm, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma |
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| 相 | 第1/2相 |
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| スポンサー | National Cancer Institute (NCI) |
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| ステータス | 実施中(募集終了) |
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| 参加者数 | 88 名 |
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| 介入(薬剤) | Laboratory Biomarker Analysis, Pharmacogenomic Study, Pharmacological Study, Topotecan Hydrochloride, Veliparib |
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| 開始日 | 2009年11月3日 |
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| 完了日 | 2019年1月13日 |
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| 結果公開日 | 2023年7月19日 |
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概要
This phase I/II trial studies the side effects and best dose of veliparib and topotecan hydrochloride and to see how well they work in treating patients with solid tumors, ovarian cancer that has come back or does not respond to treatment, or primary peritoneal cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan 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. Giving veliparib with chemotherapy may kill more tumor cells.
Maximum Tolerated Dose of Topotecan Hydrochloride and Veliparib, Determined According to Incidence of Dose-limiting Toxicity, Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I)
4 weeks · Participants
| Phase 1 Dose Level 1 | 0 Participants |
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| Phase 1 Dose Level 2 | 0 Participants |
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| Phase 1 Dose Level 3 | 0 Participants |
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| Phase 1 Dose Level 4 | 0 Participants |
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| Phase 1 Dose Level 5 | 3 Participants |
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| Phase 1 Dose Level 6 | 2 Participants |
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Percent of Patients With Tumor Response, Defined as Complete Response or Partial Response as Assessed Using Response Evaluation Criteria In Solid Tumors
Up to 48 weeks (12 courses) · percent of patients with response
| Phase 1 Dose Level 1 | 0 percent of patients with response |
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| Phase 1 Dose Level 2 | 33 percent of patients with response |
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| Phase 1 Dose Level 3 | 0 percent of patients with response |
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| Phase 1 Dose Level 4 | 0 percent of patients with response |
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| Phase 1 Dose Level 5 | 17 percent of patients with response |
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| Phase 1 Dose Level 6 | 0 percent of patients with response |
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