CClinicalTrials.gg
Not yet recruitingNCT05187208POLOUpdated Jan 26, 2022

PARP Inhibitor Oral Maintenance in Low-Risk Ovarian Cancer

A Phase 4 interventional study of Niraparib in Epithelial Ovarian Cancer, Ovarian Cancer and Ovarian Cancer Stage III, sponsored by Seoul National University Hospital. Not yet recruiting. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-01-26.

Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
102
Allocation
Not applicable
Ages
20 Years and older
Sex
Female
01

Study summary

This study is the phase IV, open-label, clinical trial to determine the efficacy of niraparib maintenance therapy in BRCA1/2 wild-type, advanced-stage, low-risk, primary ovarian cancer patients.

Read the detailed description

This study is a phase IV, open-label, clinical trial to determine the efficacy of niraparib maintenance therapy in BRCA1/2 wild-type, advanced-stage, low-risk, primary ovarian cancer patients. The study will assess the effectiveness of progression-free survival (12 months PFS rate) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The subject will be treated up to three years or until disease progression as below:

Niraparib 200mg or 300mg (once daily [QD])*

*The recommended starting dosage of niraparib is 200mg QD. For patients who weigh ≥77 kg and have baseline platelet count ≥150,000/μL, the recommended starting dosage is 300 mg QD.

02

Conditions studied

  • Epithelial Ovarian Cancer
  • Ovarian Cancer
  • Ovarian Cancer Stage III
  • Ovarian Cancer Stage IV

Keywords

  • Epithelial Ovarian Cancer
  • Ovarian Cancer
  • Maintenance
  • Molecular Targeted Therapy
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 102 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Participant has histologically confirmed diagnosis of FGIO stage III-IV high-grade serous or high-grade endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer will be enrolled in this study.
  2. Participant has confirmed as both germline and somatic BRCA1/2 wild-type by institution's test.
  3. Participant has no visible residual tumor after primary cytoreductive surgery (or optimally debulked) and has responded to the postoperative platinum-based combination chemotherapy (complete or partial response), remains in response, and is enrolled on study within 12 weeks of completion of the last platinum regimen
  4. Participant who is able to provide tumor slides obtained during cytoreductive surgery for a prospective examination of the homologous recombination deficiency (HRD).
  5. Female participants who are at least 20 years of age on the day of signing informed consent with
  6. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to enrollment.
  7. Participant is eligible to participate if she is not pregnant (see Appendix 2), not breastfeeding, and at least one of the following conditions applies:

    1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 2 OR
    2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 during the treatment period and for at least 180 days following the last dose of niraparib.
  8. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. The participant may also provide consent for future biomedical research; however, the participant may participate in the main study without participating in future biomedical research.
  9. Participant has adequate organ function as defined in the following table (Table 1).; all screening laboratory tests should be performed within 10 days prior to the start of study treatment.

Exclusion criteria

Exclusion Criteria:

  1. Participant has mucinous, germ cell, or borderline tumor of the ovary.
  2. Participant receives neoadjuvant chemotherapy before cytoreductive surgery.
  3. Participant has a visible residual tumor after primary cytoreductive surgery.
  4. Participant receives bevacizumab with front-line platinum-based combination chemotherapy.
  5. Participant has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis.
  6. Participant either has myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or has features suggestive of MDS/AML.
  7. Participant has a known additional malignancy that is progressing or has required active treatment within the past 2 years.

    Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ, endometrial carcinoma) that have undergone potentially curative therapy are not excluded.

    Note: Participants with synchronous primary endometrial cancer or a past history of primary endometrial cancer that met the following conditions are not excluded: Stage not greater than IA: no more than superficial myometrial invasion.

  8. Drainage of ascites during the last 2 cycles of last chemotherapy.
  9. Palliative radiotherapy within 1 week encompassing >20% of the bone marrow.
  10. Persistent >grade 2 toxicity from prior cancer therapy.
  11. Symptomatic uncontrolled brain or leptomeningeal metastases. A scan to confirm the absence of brain metastases is not required. Patients with spinal cord compression may be considered if they have received definitive treatment for this and evidence of clinically stable disease for 28 days.
  12. Major surgery within 3 weeks of starting the study or patient has not recovered from any effects of any major surgery.
  13. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
  14. History or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study treatment or is not in the best interest of the patient to participate.
  15. Patient is pregnant or breast feeding, or expecting to conceive children within the projected duration of the study treatment.
  16. Immunocompromised patients.
  17. Patients with known active hepatic disease (i.e., Hepatitis B or C).
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
102 participants (estimated)

Study arms

  • Experimental
    Experimental

    BRCA1/2 wild-type, advanced-stage, low-risk, primary ovarian cancer patients (high-grade serous or high-grade endoemtrioid)

    Drug: Niraparib

Interventions

  • DrugNiraparib

    Niraparib 200mg or 300mg (once daily \[QD\])\* \*The recommended starting dosage of niraparib is 200mg QD. For patients who weigh ≥77 kg and have baseline platelet count ≥150,000/μL, the recommended starting dosage is 300 mg QD.

06

What researchers measure

Primary outcomes

  1. Progression-free survival (12 month PFS rate)

    To determine the clinical effectiveness of the study treatment assessed using progression free survival (12 months) according to RECIST v1.1 criteria (Investigator determined)

    Time frame: 12 months

Secondary outcomes

  1. Progression-free survival

    Time frame: 36 months

  2. Overall survival (OS)

    Time frame: 36 months

  3. Time to second objective disease progression (PFS2)

    Time frame: 36 months

  4. Time to second subsequent treatment (TSST)

    Time frame: 36 months

Other outcomes

  1. 12 month PFS rate by homologous recombination deficiency (HRD) status

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05187208
Lead sponsor
Seoul National University Hospital
Collaborators
Yonsei University, Asan Medical Center, Samsung Medical Center, Takeda
Responsible party
Jae-Weon Kim (Seoul National University Hospital, Seoul National University Hospital) — Principal investigator
First posted
Jan 11, 2022
Start date
Jan 2022 (estimated)
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jan 26, 2022

Study contacts

Jae-Weon Kim, MD, PhD
Contact
kjwksh@snu.ac.kr
82-2072-2821
Se Ik Kim, MD, PhD
Contact
seikkim1@snu.ac.kr
82-2072-2821
Jae-Weon Jae-Weon, MD, PhD
principal investigator · Seoul National University Hpospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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