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Sarcoma,Soft TissuePhase 2NCT05515575

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

A Phase 2 study testing Niraparib in people with Sarcoma,Soft Tissue and Sarcoma Uterus, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma,Soft Tissue, Sarcoma Uterus
What is being tested?
Niraparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
7 sitesUnited States
Study dates
23 Aug 2022to Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 75Show fewer
  • 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
  • ATR OTHER
  • CHEK1 OTHER
  • CHEK2 OTHER
  • ERCC4 NER
  • ERCC8 NER
  • FANCA FA
  • FANCC FA
  • FANCD2 FA
  • FANCE FA
  • FANCF FA
  • FANCG FA
  • FANCI FA
  • FANCL FA
  • FANCM FA/HR
  • MDC1 OTHER
  • PARP1 BER
  • RAD23B NER
  • RECQL4 HR
  • RPA1 NER
  • SLX4 FA/HR
  • XRCC2 FA/HR
  • XRCC4 NHEJ
  • XRCC6 NHEJ
  • A= Fanconi Anemia BER = Base Excision Repair NER = Nucleotide Excision Repair HR = Homologous Recombination NHEJ = Non-homologous End Joining
  • Additional genes may be added to Appendix 18.1 in a study addendum as medical and scientific research and/or diagnostic testing evolves
  • Alterations of uncertain significance must be approved for inclusion by the Principal Investigator
  • Performance status of ECOG ≤ 2
  • Progressed on at least 1 prior line of systemic therapy.
  • Patients who decline standard of care first-line systemic therapy will be permitted to enroll
  • Prior adjuvant therapy will not count if it was completed more than 1 year before the date of consent
  • Presence of measurable disease by RECIST 1.1
  • Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to enrollment.
  • Adequate organ function determined within 14 days of treatment initiation, defined below:
  • Absolute neutrophil count (ANC) ≥ 1.5 K/mcL
  • Platelets ≥ 100 K/ mcL
  • Hemoglobin ≥ 9 g/dL
  • Serum creatinine OR Measured or calculated creatinine clearance Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 . For calculated CrCL, the Cockcroft Gault formula or institutional standard formula can be used.
  • Serum total bilirubin ≤1.5 X ULN OR ≤2 X ULN if hyperbilirubinemia is due to Gilbert's syndrome
  • AST (SGOT) and ALT (SGPT) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); if liver metastases, then ≤ 5 × ULN
  • International Normalized Ratio ≤1.5 X ULN (≤ 2.5 × ULN if on anticoagulants)
  • Women of childbearing potential must have a negative serum pregnancy test at screening and ≤ 72 hours prior to the first dose of study treatment.
  • Women of childbearing potential must be willing to use a highly effective method of contraception and not breastfeed for the duration of the study and for at least 6 months after the last dose of study medication
  • Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
  • Non-sterile male subjects and their female partners must be willing to use a highly effective method of contraception during the study treatment period and for at least 3 months after the last dose of study treatment. Nonsterile males must avoid sperm donation for the duration of the study and for at least 3 months after last study drug.
  • Prior chemotherapy or any investigational therapies or other anti-cancer agent must have been completed at least 4 weeks before the study drug administration. All AEs must be ≤ NCI CTCAE v5 Grade 1, except alopecia and stable neuropathy, which must have resolved to Grade ≤ 2 or baseline. Patients who were treated with estrogen modulating therapies (aromatase inhibitors, tamoxifen, GnRH agonists etc.) must have been treated at least 2 weeks prior to study drug administration.
  • Radiation therapy encompassing >20% of the bone marrow is prohibited within 2 weeks prior to Day 1 and during study treatment. Note: Palliative radiation therapy to a small field >1 week prior to Day 1 of study treatment may be allowed.
  • Patients must have normal blood pressure or adequately treated and controlled hypertension. (i.e. systolic BP ≤ 140 mmHg and diastolic BP ≤ 90 mmHg) .
  • Patients receiving corticosteroids may continue as long as their dose is stable for at least 4 weeks prior to initiating protocol therapy.
  • Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with documented undetectable viral load and CD 4 count ≥350 within 6 months of the first dose of study treatment are eligible for this trial.

Who cannot join

  • 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
Show all 26Show fewer
  • 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
  • Patients with HCV on treatment are eligible if HCV viral load is below the level of quantification

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Memorial Sloan Kettering Cancer Center (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

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

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: Phase II Study of Niraparib in Soft Tissue Sarcoma Patients With Altered DNA Damage Repair

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.

Being tested
Niraparib
Keywords
Niraparib, 22-089
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NiraparibDrug

    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.

Study groups in NCT05515575
Study groupRoleWhat they receive
NiraparibExperimentalThis 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.
Receives: Drug: Niraparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (2)

  1. Assess adverse events

    as defined by CTCAE v 5.0

    Measured: 2 years

  2. Progression free survival (PFS)

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2022
  2. Study start23 Aug 2022
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This will be a single-center, open label, phase II study of niraparib and will utilize Simon's two-stage design.
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05515575
Sponsor's protocol ID
22-089
Status last verified
Sep 2026
First submitted
23 Aug 2022
Last updated
3 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Niraparib in people with Sarcoma,Soft Tissue and Sarcoma Uterus, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 75 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05515575.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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