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
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
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: DrugTrial 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?
| Ohio | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Ohio State University Comprehensive Cancer Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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Conditions
Cancer Related
Treatments