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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

Study Summary

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

Eligible Conditions
  • Leiomyosarcoma
  • 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

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

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
320 Previous Clinical Trials
290,167 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment a revolutionary advancement in the field?

"The initial research into Niraparib Tosylate Monohydrate began in 2016, initiated by Myriad Genetics, Inc. Upon the completion of their Phase 3 trial involving 733 patients, this drug was officially approved for distribution and usage. Currently there are 99 active studies encompassing 485 cities and 49 countries."

Answered by AI

Could you please provide an overview of the research conducted on Niraparib Tosylate Monohydrate?

"At present, 99 medical studies exploring Niraparib Tosylate Monohydrate are underway. Out of these trials, 13 have entered Phase 3 testing. While the bulk of research is based in Washington D.C., there are 2816 locations globally partaking in this trial."

Answered by AI

Are medical facilities accepting new participants for this research study?

"The data hosted on clinicaltrials.gov reveals that the trial, initially posted in September of 2022 and most recently updated in July of 2022 is no longer enrolling patients. That said, currently there are 559 additional studies actively recruiting participants."

Answered by AI

What is the aggregate number of people that have enrolled in this experiment?

"Unfortunately, this clinical trial is no longer accepting participants. The study was first published on September 1st 2022 and received its last amendment the 25th of July 2022. For those searching for other such trials, there are currently 460 studies recruiting patients with advance directives and 99 involving Niraparib Tosylate Monohydrate in need of volunteers."

Answered by AI

Has the U.S. Food and Drug Administration given clearance to Niraparib Tosylate Monohydrate?

"Based on the Phase 2 trial data, Niraparib Tosylate Monohydrate is estimated to have an overall safety rating of two. Although there exists some evidence that it may be safe, no studies support its efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
Ohio State University Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Niraparib for the Treatment of Leiomyosarcoma
David Liebner, MD 2023. "Niraparib for the Treatment of Leiomyosarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05174455.
~0 spots leftby Dec 2024
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