BENITIONSClinical Trial Intelligence

Veliparib and Topotecan Hydrochloride in Treating Patients With Solid Tumors, Relapsed or Refractory Ovarian Cancer, or Primary Peritoneal Cancer

1/2상 진행 중(모집 완료) NCT01012817

대상 질환Metastatic Malignant Solid Neoplasm, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
임상 단계1/2상
스폰서National Cancer Institute (NCI)
상태진행 중(모집 완료)
참여자 수88 명
중재(약물)Laboratory Biomarker Analysis, Pharmacogenomic Study, Pharmacological Study, Topotecan Hydrochloride, Veliparib
시작일2009년 11월 3일
완료일2019년 1월 13일
결과 공개일2023년 7월 19일

요약

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 10 Participants
Phase 1 Dose Level 20 Participants
Phase 1 Dose Level 30 Participants
Phase 1 Dose Level 40 Participants
Phase 1 Dose Level 53 Participants
Phase 1 Dose Level 62 Participants

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 10 percent of patients with response
Phase 1 Dose Level 233 percent of patients with response
Phase 1 Dose Level 30 percent of patients with response
Phase 1 Dose Level 40 percent of patients with response
Phase 1 Dose Level 517 percent of patients with response
Phase 1 Dose Level 60 percent of patients with response

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