PARP Inhibitor

Niraparib for Soft Tissue Sarcoma

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, NJ
Targeting 2 different conditionsNiraparibPhase 2RecruitingLed by William Tap, MDResearch Sponsored by Memorial Sloan Kettering Cancer Center

Study Summary

This trial will test the effectiveness of niraparib against unresectable and/or metastatic soft tissue sarcoma with DDR mutations. It will also study the safety and side-effects of niraparib.

Eligible Conditions
  • Soft Tissue Sarcoma
  • Uterine Sarcoma

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have specific gene mutations related to DNA damage repair pathways, and have progressed on at least one prior line of systemic therapy. You must have measurable disease and normal organ function. You cannot be pregnant or breastfeeding, and must use contraception during and after the study. You cannot have had chemotherapy or investigational therapies within the past 4 weeks, and must have normal blood pressure or controlled hypertension.


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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Assess adverse events
Progression free survival (PFS)

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: NiraparibExperimental Treatment1 Intervention
This study will utilize Simon's two-stage design: 16 patients will be enrolled in the first portion of this study. If 4 or more patients are progression-free at 12 weeks, an additional 16 patients will be enrolled for a total of n = 32 patients enrolled.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4

Find a site

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,878 Previous Clinical Trials
585,073 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,697 Previous Clinical Trials
8,036,836 Total Patients Enrolled
William Tap, MDPrincipal Investigator
Memorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
752 Total Patients Enrolled

Media Library

Niraparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05515575 — Phase 2
Soft Tissue Sarcoma Research Study Groups: Niraparib
Soft Tissue Sarcoma Clinical Trial 2023: Niraparib Highlights & Side Effects. Trial Name: NCT05515575 — Phase 2
Niraparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05515575 — Phase 2

Frequently Asked Questions

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

Has Niraparib been cleared by the FDA?

"Since this is a phase 2 trial, meaning that while there is some evidence of safety, there is none for efficacy, we have rated Niraparib as a 2 in terms of safety."

Answered by AI

What is the projected scope of this clinical trial in terms of participants?

"The information available on seems to suggest that this study is still open to enrolling patients. This trial was originally posted on August 23rd, 2022 and was last updated September 7th, of the same year. The researchers conducting this study hope to recruit 32 participants from 7 different locations."

Answered by AI

Are there any participants still needed for this research?

"That is correct, the online information shows that the trial is open and looking for volunteers. The listing went up on 8/23/2022 and was updated most recently on 9/7/2022. They need 32 people in total and have 7 different centres where patients can be recruited from."

Answered by AI

In how many different areas is this investigation being conducted today?

"Currently, there are 7 active sites for this research study. They are situated in Basking Ridge, Middletown and New York amongst other places. To limit the amount of travel needed, please choose the site closest to your location."

Answered by AI
~21 spots leftby Aug 2026