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PARP Inhibitor
Niraparib for the Treatment of 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years after study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years after study treatment
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 moreAwards & 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.
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Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
342 Previous Clinical Trials
293,207 Total Patients Enrolled
David Liebner, MDLead Sponsor
James L Chen, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You should not have any known allergies or hypersensitivity to the ingredients in niraparib.You have not received any previous treatment with PARP inhibitors.You have cancer that has spread to other parts of your body and cannot be removed by surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (Niraparib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.