Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer
Phase 1/2
Active, not recruiting
NCT01012817
| Condition | Metastatic Malignant Solid Neoplasm, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma |
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| Phase | Phase 1/2 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 88 participants |
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| Interventions | Laboratory Biomarker Analysis, Pharmacogenomic Study, Pharmacological Study, Topotecan Hydrochloride, Veliparib |
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| Start date | Nov 3, 2009 |
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| Completion date | Jan 13, 2019 |
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| Results posted | Jul 19, 2023 |
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Summary
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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Open in BENITIONS
View on ClinicalTrials.gov
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