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PARP Inhibitor

Niraparib Tosylate Monohydrate for Leiomyosarcoma

Phase 2
Waitlist Available
Led By James L Chen, MD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years after study treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial tests whether niraparib can shrink tumors in patients with leiomyosarcoma. Niraparib stops cancer cells from repairing their damaged DNA, leading to their death. It targets patients with specific genetic changes in their cancer. Niraparib is an oral medication approved for maintenance treatment in various cancers including ovarian cancer.

Eligible Conditions
  • Leiomyosarcoma
  • Cancer
  • Retroperitoneal Sarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years after study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years after study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Confirmed objective response rate (ORR)
Secondary study objectives
Confirmed clinical benefit rate (CBR)
Incidence of adverse events (AEs)
Overall survival (OS)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (Niraparib)Experimental Treatment1 Intervention
Patients receive niraparib PO QD. Cycles repeat every 28 days for 15 months in the absence of disease progression or unacceptable toxicity.

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
340 Previous Clinical Trials
294,495 Total Patients Enrolled
David Liebner, MDLead Sponsor
James L Chen, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Media Library

Niraparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05174455 — Phase 2
Leiomyosarcoma Research Study Groups: Treatment (Niraparib)
Leiomyosarcoma Clinical Trial 2023: Niraparib Highlights & Side Effects. Trial Name: NCT05174455 — Phase 2
Niraparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05174455 — Phase 2
~0 spots leftby Dec 2024
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