BENITIONSClinical Trial Intelligence

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

ConditionMetastatic Malignant Solid Neoplasm, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
PhasePhase 1/2
SponsorNational Cancer Institute (NCI)
StatusActive, not recruiting
Enrollment88 participants
InterventionsLaboratory Biomarker Analysis, Pharmacogenomic Study, Pharmacological Study, Topotecan Hydrochloride, Veliparib
Start dateNov 3, 2009
Completion dateJan 13, 2019
Results postedJul 19, 2023

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 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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