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A Study of Niraparib in People With Soft Tissue Sarcoma Who Have Changes in Their Tumor DNA

NCT05515575 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-10-20

No results posted yet for this study

Summary

The purpose of this study is to test whether the study drug, niraparib, is effective against unresectable and/or metastatic soft tissue sarcoma with DDR mutations. The researchers will also study whether niraparib is safe and causes few or mild side effects, and whether there are groups of DDR mutations in soft tissue sarcoma cells that respond better to treatment with niraparib.

Conditions

  • Sarcoma,Soft Tissue
  • Sarcoma Uterus

Interventions

DRUG

Niraparib

Each patient will receive niraparib daily in 21-day cycles until disease progression or unacceptable toxicity. Mandatory baseline tumor biopsies will occur during study screening, if feasible.

Sponsors & Collaborators

Principal Investigators

  • Sujana Movva, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-23
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05515575 on ClinicalTrials.gov