Trials / Active Not Recruiting
Active Not RecruitingNCT05515575
A Study of Niraparib in People With Soft Tissue Sarcoma Who Have Changes in Their Tumor DNA
Phase II Study of Niraparib in Soft Tissue Sarcoma Patients With Altered DNA Damage Repair
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-08-23
- Primary completion
- 2026-08-01
- Completion
- 2026-08-01
- First posted
- 2022-08-25
- Last updated
- 2025-10-20
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05515575. Inclusion in this directory is not an endorsement.