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Ovarian CancerPhase 2NCT04507841

Niraparib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer

A Phase 2 study testing Niraparib in people with Ovarian Cancer, run by Tongji Hospital at 1 site in China.

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

This is a prospective, interventional, single-arm, open-label, phase II study to evaluate the safety and efficacy of niraparib monotherapy as neoadjuvant therapy in patients with advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer ((FIGO stage III or IV), who had low likelihood of achieving R0… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Niraparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteChina
Study dates
8 Jan 2021to 31 Dec 2026
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The informed consent form must be provided before any procedure of the trial, and the informed consent form shall be filed in the research center;
  • Female patients aged between 18 and 75 years old;
  • Patients received open surgery, laparoscopic surgery, or coarse needle aspiration biopsy and confirmed as high-grade serous or endometrioid ovarian cancer, peritoneal cancer, or fallopian tube cancer (hereinafter referred to as ovarian cancer). FIGO stage III-IV;
  • BRCA1/2 gene mutation or HRD was confirmed by tissue or blood samples detected by the testing institution designated by the research center;
  • Blood and tissue samples can be obtained before, during, and after treatment, and the subjects agree to submit the blood and tissue samples to the central laboratory for the expanded research purposes of the trial, including but not limited to: I. possible gene-related research. II. Possible tumor markers related studies;
  • There is at least one lesion that can be measured by CT / MRI;
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  • The professional gynecological oncologists appointed by each center should judge the patients who can not achieve R0 tumor reduction or can not tolerate surgery,
  • The criteria for failure to achieve R0 tumor reduction include but are not limited to:
  • Fagotti score ≥ 8 [2];
  • When the laparoscopic evaluation method is difficult to implement, the upper abdominal CT Score ≥ 3 can be used [3].
  • The criteria for intolerance to surgery can be considered as follows:
  • advanced age: age ≥ 80;
  • body mass index: BMI ≥ 40.0;
  • A variety of chronic diseases;
  • malnutrition or hypoproteinemia;
  • Moderate to massive ascites;
  • Newly diagnosed venous thromboembolism;
  • physical status: ECOG > 2.
  • The expected survival time was more than 12 weeks;
  • The ECOG score was 0-2;
  • Good organ function, including:
  • Bone marrow function: neutrophil count ≥ 1500 / μ L; platelet ≥ 100000 / μ L; hemoglobin ≥ 10g / dl
  • Liver function: total bilirubin ≤ 1.5 times of the upper limit of normal value or direct bilirubin ≤ 1.0 times of the upper limit of normal value; AST and alt ≤ 2.5 times of the upper limit of normal value; when liver metastasis exists, it must be ≤ 5 times of the upper limit of normal value
  • renal function: serum creatinine ≤ 1.5 times the upper limit of normal value, or creatinine clearance rate ≥ 60ml / min (calculated according to Cockcroft Gault formula);
  • For women with fertility potential, if blood test or urine pregnancy test is negative within one week before enrollment, effective contraceptive measures must be taken, such as physical barrier contraceptive method (condom) or complete abstinence. Oral, injectable or implantable hormonal contraceptives are not allowed. Or women without reproductive potential, defined as:
  • Natural menopause and menopause for more than 1 year;
  • Surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy);
  • serum follicle-stimulating hormone, luteinizing hormone, and plasma estradiol levels were within the menopausal criteria of the research center laboratory.
  • Understand the trial process and have the ability to comply with the trial protocol for the trial duration, including any treatment, examination, inspection, follow-up, and questionnaire required for the completion of the experiment;
  • The patients were willing to complete the questionnaire survey of quality of life during the trial treatment and follow-up, and agreed that the results of the questionnaire survey could be used in clinical research;
  • The toxicity of any previous chemotherapy has returned to ≤ CTCAE 1 or baseline level, except for sensory neuropathy or alopecia with stable symptoms ≤ CTCAE grade 2.

Who cannot join

  • -
  • The enrolled patients should not contain any of the following conditions:
  • Personnel involved in the formulation or implementation of the research plan;
  • Other clinical drug experiments participated in by using other experimental research drugs at the same time as the study;
  • At the same time of this study, other neoadjuvant therapies for cancer should be used, including but not limited to chemotherapy, radiotherapy, immunotherapy, microbial therapy, traditional Chinese medicine treatment, and other experimental therapies;
  • Those who are known to be allergic to niraparib or active or inactive components of drugs with a similar chemical structure to niraparib;
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  • Inability to swallow oral drugs and any gastrointestinal diseases that may interfere with the absorption and metabolism of the study drugs, such as uncontrollable nausea and vomiting, gastrointestinal obstruction or malabsorption;
  • Have received any anti-cancer treatment for ovarian cancer;
  • Have been treated with known or possible PARP inhibitors in the past;
  • Symptomatic or uncontrolled brain metastases requiring simultaneous treatment, including but not limited to surgery, radiation and / or corticosteroids, or clinical manifestations of spinal cord compression;
  • Major surgery was performed within 3 weeks before the start of the study or did not recover after the operation;
  • The subjects had other malignant diseases in the past 3 years, except skin squamous cell carcinoma, basal-like carcinoma, breast intraductal carcinoma in situ, or cervical carcinoma in situ.
  • The patient had a previous or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
  • Patients with serious and uncontrollable diseases or the general situation of the subjects judged by the researchers to be unsuitable for joining the study, including but not limited to: active viral infection, such as human immunodeficiency virus, hepatitis B, hepatitis C, etc.; severe cardiovascular disease, uncontrollable ventricular arrhythmia, myocardial infarction in the last three months; uncontrollable epileptic grand mal seizure, no control Stable spinal cord compression, superior vena cava syndrome or other mental disorders that affect patients' informed consent; hypertension beyond drug control; immune deficiency (except splenectomy) or other diseases that researchers believe may expose patients to high-risk toxicity; and;
  • Any medical history or existing clinical evidence indicates that there may be confusion of study results, interference with patients' compliance with the trial protocol throughout the study treatment period, or not in the best interests of patients;
  • The patient received platelet or red blood cell transfusion within four weeks before the start of treatment of the study drug;
  • Patients who are pregnant or breastfeeding, or who plan to become pregnant during the study treatment.
  • Unsolved clinical toxicity (≥ grade 2, except alopecia, neuralgia, lymphopenia, and depigmentation of skin)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tongji Hospital

    Wuhan, Hubei, 430000

Other trials in China

About this study

This is a prospective, interventional, single-arm, open-label, phase II study to evaluate the safety and efficacy of niraparib monotherapy as neoadjuvant therapy in patients with advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer ((FIGO stage III or IV), who had low likelihood of achieving R0 cytoreduction by imaging assessment or laparoscopic evaluation, or cannot tolerate PDS by poor conditions.

Conditions
Ovarian Cancer
Being tested
Niraparib
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • NiraparibDrug

    Neoadjuvant niraparib monotherapy with an individualized starting dose of 200mg/day or 300mg/day based on body weight or platelet count. The 28-day treatment cycle consists of 21 days of medication followed by a 7-day break. Two cycles of neoadjuvant niraparib monotherapy were used, and the investigator may choose to have an additional cycle based on the patient's condition.

Study groups in NCT04507841
Study groupRoleWhat they receive
Niraparib groupExperimentalNiraparib was used in patients with newly diagnosed ovarian cancer before any treatment with an individualized starting dose of 200mg/day or 300mg/day based on body weight or platelet count.
Receives: Drug: Niraparib

What is being measured

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

  1. R0 resection rate

    the percentage of patients received R0 resection after Niraparib neoadjuvant treatment.

    Measured: 3-month

  2. Overall Response Rate (ORR) After Neoadjuvant treatment

    Overall Response Rate according to RECIST1.1 after Neoadjuvant treatment. ORR is defined as the proportion of participants achieving Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST (v.1.1). Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of diameters (SoD) of target lesions.

    Measured: 3-month

Secondary outcomes (9)

  1. Disease Control Rate

    Disease control rate is defined as the proportion of participants achieving Complete Response (CR), Partial Response (PR) or Stable Disease (SD) according to RECIST1.1 and CA125 according to GCIC guidelines

    Measured: 3-month

  2. Complete pathologic response rate

    Complete pathologic response rate is measured according to Miller-Panye system.

    Measured: 3-month

  3. Progression Free Survival (PFS)

    PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measured: 3-year

  4. Overall survival (OS)

    Overall survival. OS is defined as the time from the study enrollment to death due to any cause.

    Measured: 5-year

  5. Quality of Life (QOL) measures using Functional Assessment of Cancer Therapy (FACT- ovarian cancer)

    To evaluate quality of life (QOL) for the subjects undergoing this treatment, using validated tools. QOL will be assessed every 3 months during treatment course. [Functional Assessment of Cancer Therapy - Ovarian Cancer questionnaire (score range from 0 to 160. Higher scores represent better quality of life.

    Measured: 5 years

  6. Patient report outcome, EQ-VAS

    life quality assessment. EQ-VAS, EuroQol-visual analogue scales. Score range from 0 [worse outcome] to 10 [better outcome]).

    Measured: 3 years

  7. Rate of treatment interruption and termination

    The rate of treatment interruption and termination caused by patients' intolerance of treatment side effects and other reasons;

    Measured: 5 years

  8. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    To further describe safety and assess toxicities encountered with the use of the proposed treatment regimen in patients with stage III, all stage IV ovarian cancer.

    Measured: 5 years

  9. Overall Response Rate (ORR) during niraparib maintain treatment

    Overall Response Rate according to RECIST1.1 during niraparib maintain treatment.

    ORR is defined as the proportion of participants achieving Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST (v.1.1). Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of diameters (SoD) of target lesions.

    Measured: 1 year

Timeline

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

  1. First posted11 Aug 2020
  2. Study start8 Jan 2021
  3. Primary completion25 Sep 2023
  4. Study completion31 Dec 2026 (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
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04507841
Sponsor's protocol ID
2019-TJ-OVNN
Status last verified
Dec 2024
First submitted
6 Aug 2020
Last updated
17 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Contact Prof. Gao for primary data.

Publications

  • Mirza MR, Monk BJ, Herrstedt J, Oza AM, Mahner S, Redondo A, Fabbro M, Ledermann JA, Lorusso D, Vergote I, Ben-Baruch NE, Marth C, Madry R, Christensen RD, Berek JS, Dorum A, Tinker AV, du Bois A, Gonzalez-Martin A, Follana P, Benigno B, Rosenberg P, Gilbert L, Rimel BJ, Buscema J, Balser JP, Agarwal S, Matulonis UA; ENGOT-OV16/NOVA Investigators. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer. N Engl J Med. 2016 Dec 1;375(22):2154-2164. doi: 10.1056/NEJMoa1611310. Epub 2016 Oct 7.

    PubMed 27717299

  • Gonzalez-Martin A, Pothuri B, Vergote I, DePont Christensen R, Graybill W, Mirza MR, McCormick C, Lorusso D, Hoskins P, Freyer G, Baumann K, Jardon K, Redondo A, Moore RG, Vulsteke C, O'Cearbhaill RE, Lund B, Backes F, Barretina-Ginesta P, Haggerty AF, Rubio-Perez MJ, Shahin MS, Mangili G, Bradley WH, Bruchim I, Sun K, Malinowska IA, Li Y, Gupta D, Monk BJ; PRIMA/ENGOT-OV26/GOG-3012 Investigators. Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2391-2402. doi: 10.1056/NEJMoa1910962. Epub 2019 Sep 28.

    PubMed 31562799

  • Berek JS, Matulonis UA, Peen U, Ghatage P, Mahner S, Redondo A, Lesoin A, Colombo N, Vergote I, Rosengarten O, Ledermann J, Pineda M, Ellard S, Sehouli J, Gonzalez-Martin A, Berton-Rigaud D, Madry R, Reinthaller A, Hazard S, Guo W, Mirza MR. Safety and dose modification for patients receiving niraparib. Ann Oncol. 2018 Aug 1;29(8):1784-1792. doi: 10.1093/annonc/mdy181.

    PubMed 29767688

  • Mirza MR, Avall Lundqvist E, Birrer MJ, dePont Christensen R, Nyvang GB, Malander S, Anttila M, Werner TL, Lund B, Lindahl G, Hietanen S, Peen U, Dimoula M, Roed H, Or Knudsen A, Staff S, Krog Vistisen A, Bjorge L, Maenpaa JU; AVANOVA investigators. Niraparib plus bevacizumab versus niraparib alone for platinum-sensitive recurrent ovarian cancer (NSGO-AVANOVA2/ENGOT-ov24): a randomised, phase 2, superiority trial. Lancet Oncol. 2019 Oct;20(10):1409-1419. doi: 10.1016/S1470-2045(19)30515-7. Epub 2019 Aug 29.

    PubMed 31474354

  • Liu D, Peng Z, Zhang W, Feng C, Wang P, Li J, Wen Y, Shan W, Xia Y, Li H, Li B, Liu R, Wu M, Li Z, Liu R, Chen G, Wang Y, Jiao X, Li X, Liu C, Yin R, Zhou S, Li M, Xia Z, Dong Y, He S, Huang Y; COCPO Consortium; Song K, Hong L, Ma D, Fang Y, Gao Q. Neoadjuvant niraparib monotherapy for unresectable, homologous recombination deficiency-positive, high-grade serous ovarian cancer (NANT): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2026 Oct 7:S1470-2045(26)00387-6. doi: 10.1016/S1470-2045(26)00387-6. Online ahead of print.

    PubMed 42843394

  • Jin N, Qian YY, Jiao XF, Wang Z, Li X, Pan W, Jiang JK, Huang P, Wang SY, Jin P, Gao QL, Liu D, Xia Y. Niraparib restricts intraperitoneal metastases of ovarian cancer by eliciting CD36-dependent ferroptosis. Redox Biol. 2025 Mar;80:103528. doi: 10.1016/j.redox.2025.103528. Epub 2025 Feb 3.

    PubMed 39922130

  • Xia Y, Huang P, Qian YY, Wang Z, Jin N, Li X, Pan W, Wang SY, Jin P, Drokow EK, Li X, Zhang Q, Zhang Z, Li P, Fang Y, Yang XP, Han Z, Gao QL. PARP inhibitors enhance antitumor immune responses by triggering pyroptosis via TNF-caspase 8-GSDMD/E axis in ovarian cancer. J Immunother Cancer. 2024 Oct 4;12(10):e009032. doi: 10.1136/jitc-2024-009032.

    PubMed 39366751

  • Zhou D, Liu J, Liu R, Li H, Huang Y, Ma D, Hong L, Gao Q. Effectiveness and Safety of Niraparib as Neoadjuvant Therapy in Advanced Ovarian Cancer With Homologous Recombination Deficiency (NANT): Study Protocol for a Prospective, Multicenter, Exploratory, Phase 2, Single-Arm Study. Front Oncol. 2022 Mar 23;12:852772. doi: 10.3389/fonc.2022.852772. eCollection 2022.

    PubMed 35402241

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Niraparib in people with Ovarian Cancer, run by Tongji Hospital at 1 site in China.

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 31 inclusion and 18 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 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

R0 resection rate (time frame: 3-month). The study lists 2 primary outcomes in all. 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 NCT04507841, which also lists 8 linked publications.

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 17 Dec 2024.

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