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

NCT05515575 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 22-089
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

Niraparib; 22-089

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Defined by RECIST 1.1. PFS is defined as the period from start of study treatment until recurrent or progressive of disease (POD) is objectively documented (taking as reference for progressive disease the smallest measurement recorded on study), death, or date of last study visit involving assessment of disease status.

  12 weeks

Secondary Outcomes (2)

• Assess adverse events

  2 years

• Progression free survival (PFS)

  24 weeks

Study Arms (1)

Niraparib

EXPERIMENTAL

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.

Drug: Niraparib

Interventions

Niraparib DRUG

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.

Niraparib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years at the time of informed consent
• Participants or their legally authorized representatives (LARs) need to be willing to provide written informed consent/assent for the trial
• Be willing to comply with treatment protocol
• Histologically confirmed unresectable or metastatic soft tissue or uterine sarcoma
• Known deleterious or suspected deleterious alteration in at least one of the following prespecified DDR pathway genes:
• Core Genes
• Gene Pathway
• BRCA1 FA/HR
• BRCA2 FA/HR
• BRIP1 FA/HR
• BARD1 FA/HR
• BLM FA/HR
• PALB2 FA
• MRE11 HR
• NBN HR

You may not qualify if:

• Patient is simultaneously enrolled on any therapeutic clinical trial.
• Patient has had major surgery within 3 weeks prior to initiating protocol therapy. Note: patient must have recovered from any surgical effects.
• Uncontrolled intercurrent illness including current active or chronic infection requiring systemic therapy or the following cardiac criteria:
• Symptomatic congestive heart failure (NYHA classification III or IV) within 6 months
• Acute myocardial infarction ≤6 months prior to Day 1
• Grade ≥2 ventricular arrhythmia ≤6 months prior to Day 1
• History of cerebrovascular accident within 6 months before first dose of study drugs
• Participant has leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiologic signs of CNS hemorrhage.
• Note: Participants with asymptomatic brain metastases (i.e. off corticosteroids and anticonvulsants for at least 7 days) are permitted.
• Known history of active Mycobacterium tuberculosis infection
• Prior therapy with a PARP inhibitor
• Patients who have not recovered from clinically significant adverse events of prior therapy to ≤ NCI CTCAE v5 Grade 1, except alopecia and stable neuropathy, which must have resolved to Grade ≤ 2 or baseline.
• °If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy events due to a previously administered agent.
• Presence of a gastrointestinal condition that may affect drug absorption
• Known allergy or reaction to any component of the study drug or its excipients.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• GlaxoSmithKline: collaborator

Study Sites (7)

Memorial Sloan Kettering Cancer Center (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Cancer Center Suffolk- Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Sarcoma

Interventions

niraparib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Sujana Movva, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a single-center, open label, phase II study of niraparib and will utilize Simon's two-stage design.

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2022
• Study Start: August 23, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (7)