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Ovarian CancerPhase 2NEOPRIMANCT04284852

Niraparib Maintenance in Patients With Advanced Ovarian Cancer at Neoadjuvant Setting

A Phase 2 study testing Niraparib in people with Ovarian Cancer, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate the effects of niraparib in those who have received neoadjuvant chemotherapy and subsequent interval debulking surgery, with or without hyperthermic intraperitoneal chemotherapy, and would also explore if there are any biomarkers, other than BRCA / HRD status and platinum sensitivity, that… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Niraparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteHong Kong
Study dates
1 May 2020to 1 Oct 2023
Phase
Phase 2
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be at least 18 years old.
  • Patients must have newly diagnosed, histologically confirmed high grade, serous or endometrioid, FIGO stage 3 or 4, ovarian, fallopian tube or primary peritoneal carcinoma before the start of NACT.
  • Patients must have received 3 - 4 cycles of NACT containing either carboplatin or cisplatin, IDS with or without HIPEC, and 3 - 6 more cycles of adjuvant chemotherapy, prior to recruitment into the study.
  • The patients should have only one cytoreductive surgery.
  • The patients must show either complete (CR) or partial response (PR) to the platinum-based chemotherapy using RECIST 1.1 criteria.
  • Patients should not be amenable to further surgery or radiotherapy except for the purpose of symptomatic relief.
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  • All surgery, chemotherapy and radiotherapy should finish more than 3 weeks prior to recruitment.
  • Niraparib should be started within 8 weeks after the last dose of chemotherapy.
  • Patients should have Eastern Cooperative Oncology Group (ECOG) performance score 0 to 2 within 28 days prior to recruitment.
  • Patients must have adequate bone marrow, renal, hepatic and neurological function within 28 days prior to the start of treatment.
  • Patients who have childbearing potential should practice highly effective contraception throughout the study until at least 30 days after completion of the treatment.

Who cannot join

  • Patients who are diagnosed to have low-grade or borderline carcinoma, mucinous or clear cell cystadenocarcinoma, carcinosarcoma or undifferentiated carcinoma, are excluded.
  • Patients who have stable disease or PD on the post-treatment scan or clinical evidence are excluded.
  • Patients who have drainage of ascites within 4 weeks before recruitment are excluded.
  • Patients who have with concurrent malignancy within five years (except for basal or squamous cell skin cancer or in-situ breast cancer) are excluded.
  • Patients who have history of unresolved thrombocytopenia, myelodysplastic syndrome or acute myeloid leukaemia are excluded.
  • Patients who have symptomatic brain or leptomeningeal metastases, or spinal cord compression are excluded unless these are treated and controlled within 28 days of recruitment.
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  • Patients with the significant past medical history, such as active hepatitis, myocardiac infarction, in the last six months are excluded.
  • Patients with severe gastrointestinal conditions such as evidence of bowel obstruction in the last 4 weeks prior to enrolment, or history of inflammatory bowel disease, are not eligible.
  • Patients having had severe infections within 4 weeks prior to the start of treatment are excluded.
  • Patents with active tuberculosis, history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) are excluded.
  • Patients with prior allogeneic stem cell or solid organ transplantation are excluded.
  • Those patients who suffer from CTCAE grade 2 or more toxicity from previous treatment, except alopecia, are excluded.
  • Patients who have used PARPi previously are excluded.
  • Patients who are allergic to any component of niraparib are excluded.
  • Patients who have used bevacizumab, or who are going to use bevacizumab as maintenance, are not eligible to join the study.
  • Use of other investigational drugs within 28 days or at least 5 half-lives (whichever is longer) before study drug administration is not allowed.
  • Patients who are pregnant or breastfeeding are excluded.
  • Patients must not have either platelet or red blood cell transfusion, or granulocyte colony stimulating factor (G-CSF) within 2 weeks of the first dose of study treatment.
  • Patients must not plan to donate blood during the study or for 90 days after the last dose of study treatment.
  • Patients with major operation within 28 days or open biopsy within 7 days before enrolment are not eligible.
  • Patients planned to have major surgery during the course of the study are excluded.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Niraparib Maintenance in Patients With Advanced Ovarian Cancer at Neoadjuvant Setting - a Phase 2, Single-arm Trial (NEOPRIMA Trial)

This study aims to evaluate the effects of niraparib in those who have received neoadjuvant chemotherapy and subsequent interval debulking surgery, with or without hyperthermic intraperitoneal chemotherapy, and would also explore if there are any biomarkers, other than BRCA / HRD status and platinum sensitivity, that may help to identify those who may benefit from PARPi especially those who are HRD negative.

Read the detailed description

Despite cytoreductive surgery and platinum-based chemotherapy, about 70% of patients with advanced ovarian cancer recur in the first 2 - 3 years. PARPi has been shown to be prolong survival in primary advanced ovarian cancer. However its role in neoadjuvant setting has not been fully evaluated.

Conditions
Ovarian Cancer
Being tested
Niraparib
Keywords
advanced, ovarian, cancer, neoadjuvant, niraparib
Medical subject headings
Ovarian Neoplasms, Neoplasms

What participants receive

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

  • NiraparibDrug

    Also called Zejula

    PARP inhibitor

Study groups in NCT04284852
Study groupRoleWhat they receive
Experimental armExperimentalNiraparib 200 or 300mg daily orally for 18 cycles unless disease progression or intolerable side effects (whichever occurs first)
Receives: Drug: Niraparib

What is being measured

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

  1. PFS rate at 18 months

    Proportion of patients who are progression-free at 18 months according to the RECIST 1.1

    Measured: up to 18 months

Secondary outcomes (5)

  1. PFS by the RECIST 1.1

    The time from first dose of trial medication to first documentation of objective tumor progression (PD) or to death due to any cause, whichever occurs first.

    Measured: up to 5 years

  2. Overall survival

    Overall survival is defined as the time from first dose of trial medication to date of death due to any cause.

    Measured: up to 5 years

  3. OS rate at 18 months

    Proportion of patients who are alive at 18 months

    Measured: up to 18 months

  4. Change of biomarkers

    Expression levels of markers like Ki-67 before and after chemotherapy

    Measured: up to 18 months

  5. Treatment-related adverse events

    Incidence of treatment-related adverse events classified by CTCAE version 5.0

    Measured: up to 18 months

Timeline

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

  1. First posted26 Feb 2020
  2. Study start1 May 2020
  3. Primary completion1 Oct 2023
  4. Study completion1 Oct 2023

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04284852
Sponsor's protocol ID
UW-19-681
Acronym
NEOPRIMA
Status last verified
Oct 2023
First submitted
17 Feb 2020
Last updated
15 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Niraparib in people with Ovarian Cancer, run by The University of Hong Kong at 1 site in Hong Kong.

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 21 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: finished, as of the sponsor's last update on 15 Dec 2023. 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 Hong Kong. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

PFS rate at 18 months (time frame: up to 18 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 NCT04284852.

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 15 Dec 2023.

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