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

Running, not enrolling · Phase 2

Conditions studied: Sarcoma,Soft Tissue, Sarcoma Uterus

In brief

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.

Key facts

Study ID

NCT05515575

Run by

Memorial Sloan Kettering Cancer Center

People needed

8

Starts

2022-08-23

Expected to finish

2026-08-01

Last updated by the study team

2025-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• RAD50 HR/NHEJ
• RAD51B FA/HR
• RAD51C HR
• RAD51D HR
• RAD52 HR
• RAD54B HR
• Other Genes
• Gene Pathway
• ABRAXAS1 NHEJ
• ATM OTHER

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.
• Women who are pregnant or breast feeding
• Patients expecting to have a child within the projected duration of the trial, starting with the pre-screening or screening visit through 6 months after the last dose of study treatment(s) for women or 7 months for men.
• Prior allogeneic stem cell transplantation or organ transplantation.
• Participant has received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy.
• Participant has received colony stimulating factors (e.g., granulocyte colonystimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy.
• °If growth factors were used as neutropenic fever prophylaxis during a previous treatment regimen then enrollment is allowed, as long as 2 weeks as elapsed from the prior dose
• Participant has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment.
• Participant has any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
• Participant has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [qualitative] is detected).
• Patients with chronic HBV infection with active disease who are on suppressive antiviral therapy prior to initiation of cancer therapy

Where it is running

• Memorial Sloan Kettering Cancer Center (Limited Protocol Activities) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States
• Memorial Sloan Kettering Cancer Center Suffolk- Commack (Limited Protocol Activities) — Commack, New York, United States
• Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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