AzTrials
AzTrials

Epithelial Ovarian CancerPhase 4POLONCT05187208

PARP Inhibitor Oral Maintenance in Low-Risk Ovarian Cancer

A Phase 4 study testing Niraparib in people with Epithelial Ovarian Cancer and Ovarian Cancer, run by Seoul National University Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 20 years and older, women only
What is being tested?
Niraparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
No sites listed yet
Study dates
Jan 2022to Dec 2025
Phase
Phase 4
Are there results?
None posted in the registry

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 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Participant has confirmed as both germline and somatic BRCA1/2 wild-type by institution's test.
  • 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
  • Participant who is able to provide tumor slides obtained during cytoreductive surgery for a prospective examination of the homologous recombination deficiency (HRD).
  • Female participants who are at least 20 years of age on the day of signing informed consent with
  • Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to enrollment.
Show all 11Show fewer
  • Participant is eligible to participate if she is not pregnant (see Appendix 2), not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) as defined in Appendix 2 OR
  • 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.
  • 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.
  • 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.

Who cannot join

  • Participant has mucinous, germ cell, or borderline tumor of the ovary.
  • Participant receives neoadjuvant chemotherapy before cytoreductive surgery.
  • Participant has a visible residual tumor after primary cytoreductive surgery.
  • Participant receives bevacizumab with front-line platinum-based combination chemotherapy.
  • Participant has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis.
  • Participant either has myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or has features suggestive of MDS/AML.
Show all 19Show fewer
  • 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.
  • Drainage of ascites during the last 2 cycles of last chemotherapy.
  • Palliative radiotherapy within 1 week encompassing >20% of the bone marrow.
  • Persistent >grade 2 toxicity from prior cancer therapy.
  • 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.
  • Major surgery within 3 weeks of starting the study or patient has not recovered from any effects of any major surgery.
  • 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.
  • 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.
  • Patient is pregnant or breast feeding, or expecting to conceive children within the projected duration of the study treatment.
  • Immunocompromised patients.
  • Patients with known active hepatic disease (i.e., Hepatitis B or C).

Trial locations and contacts

No sites are listed yet.

Jae-Weon Kim, MD, PhD contact

82-2072-2821

kjwksh@snu.ac.kr

Se Ik Kim, MD, PhD contact

82-2072-2821

seikkim1@snu.ac.kr

About this study

Official title: A Phase IV Open-label, Multicenter Study of Niraparib as Maintenance Therapy in BRCA Wild-type, Newly Diagnosed Advanced Ovarian Cancer Patients in Korea

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.

Being tested
Niraparib
Keywords
Epithelial Ovarian Cancer, Ovarian Cancer, Maintenance, Molecular Targeted Therapy
Medical subject headings
Carcinoma, Ovarian Epithelial, Ovarian Neoplasms

What participants receive

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

  • NiraparibDrug

    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.

Study groups in NCT05187208
Study groupRoleWhat they receive
ExperimentalExperimentalBRCA1/2 wild-type, advanced-stage, low-risk, primary ovarian cancer patients (high-grade serous or high-grade endoemtrioid)
Receives: Drug: Niraparib

What is being measured

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

  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)

    Measured: 12 months

Secondary outcomes (4)

  1. Progression-free survival

    Measured: 36 months

  2. Overall survival (OS)

    Measured: 36 months

  3. Time to second objective disease progression (PFS2)

    Measured: 36 months

  4. Time to second subsequent treatment (TSST)

    Measured: 36 months

Timeline

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

  1. First posted11 Jan 2022
  2. Study startJan 2022 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05187208
Sponsor's protocol ID
CCR-2021-200106
Acronym
POLO
Status last verified
Jan 2022
First submitted
19 Dec 2021
Last updated
26 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Niraparib in people with Epithelial Ovarian Cancer and Ovarian Cancer, run by Seoul National University Hospital.

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 11 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Jae-Weon Kim, MD, PhD (82-2072-2821, kjwksh@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (12 month PFS rate) (time frame: 12 months). 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 NCT05187208.

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 26 Jan 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in