Niraparib Tosylate Monohydrate for Leiomyosarcoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Leiomyosarcoma+10 MoreNiraparib Tosylate Monohydrate - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether niraparib, which blocks the PARP enzyme, can shrink tumors in patients with leiomyosarcoma.

Eligible Conditions
  • Leiomyosarcoma
  • Metastatic Leiomyosarcoma
  • Stage IV Soft Tissue Sarcoma
  • Stage IIIB Retroperitoneal Sarcoma
  • Stage III Soft Tissue Sarcoma
  • Stage IIIA Retroperitoneal Sarcoma
  • Stage III Retroperitoneal Sarcoma
  • Stage IIIA Soft Tissue Sarcoma
  • Stage IIIB Soft Tissue Sarcoma
  • Stage IV Retroperitoneal Sarcoma
  • Unresectable Leiomyosarcoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 2 years after study treatment

Year 2
Overall survival (OS)
Year 2
Progression-free survival (PFS)
Year 2
Incidence of adverse events (AEs)
Month 6
Confirmed clinical benefit rate (CBR)
Confirmed objective response rate (ORR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Treatment (Niraparib)
1 of 1

Experimental Treatment

22 Total Participants · 1 Treatment Group

Primary Treatment: Niraparib Tosylate Monohydrate · No Placebo Group · Phase 2

Treatment (Niraparib)
Drug
Experimental Group · 1 Intervention: Niraparib Tosylate Monohydrate · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years after study treatment

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
287 Previous Clinical Trials
285,991 Total Patients Enrolled
David Liebner, MDLead Sponsor
James L Chen, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have locally advanced and unresectable or metastatic disease.
You are eligible if you have an ECOG performance status of =< 2.
Patients must have had prior progression on, or intolerance to, at least one line of systemic therapy for advanced LMS
You are a male or female aged between 18 and 35 years old.

Who else is applying?

What state do they live in?
Ohio100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Ohio State University Comprehensive Cancer Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%