Niraparib for Ovarian Cancer

Overseen By Matthew Schlumbrecht, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Miami

Must not be taking: Cytotoxic, Hormonal

Disqualifiers: MDS, AML, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 22 months

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an investigational medication called niraparib for women with ovarian cancer. Niraparib works to prevent cancer cells from repairing their damaged genes, slowing their growth and leading to cell death. The research focuses on how genetic and environmental factors, such as African ancestry, influence the treatment's effects. Women who have completed initial treatments for advanced ovarian cancer and self-identify as Black may be suitable for this study. As a Phase 4 trial, niraparib is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking any cytotoxic, hormonal, or other medications to treat your cancer before participating.

What is the safety track record for Niraparib?

Research shows that niraparib is generally well-tolerated as a maintenance treatment for ovarian cancer. In a study with 749 patients, niraparib proved safe, with no new safety issues. Most side effects involve changes in blood cell counts, which are common but manageable. Long-term data indicate that these side effects do not worsen over time. This suggests that niraparib is a safe option for those considering joining this trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for ovarian cancer, which often include chemotherapy and surgery, Niraparib is unique because it is a PARP inhibitor. Most treatments target rapidly dividing cancer cells, but Niraparib works by interfering with the cancer cells' ability to repair their DNA, which can enhance the effectiveness of other therapies and potentially lead to longer remission periods. Researchers are excited about Niraparib because it offers a maintenance therapy option that may help keep the cancer from returning after initial treatment, making it a promising addition to the current arsenal against ovarian cancer.

What is the effectiveness track record for Niraparib in treating ovarian cancer?

Studies have shown that niraparib, administered as maintenance therapy in this trial, effectively treats ovarian cancer. Research indicates that women who took niraparib experienced a longer period before their cancer returned or worsened compared to those who did not take it. In patients with specific genetic traits, such as HRD-positive ovarian cancer, niraparib provided significant long-term benefits. Overall, niraparib has improved outcomes and delayed the need for additional treatment in women with advanced ovarian cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Matthew Schlumbrecht, MD, MPH

Principal Investigator

University of Miami

Sophia HL George, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for women with ovarian cancer. It's looking at how genetic traits, like African ancestry, and environmental factors affect the outcomes of treatment with Niraparib—a drug that stops cancer cells from repairing their DNA.

Inclusion Criteria

My cancer is high-grade serous or endometrioid.

I am not allergic to niraparib or its ingredients.

I have finished treatment for advanced ovarian, fallopian tube, or peritoneal cancer.

Exclusion Criteria

My cancer is one of the specified types (e.g., low-grade serous, clear cell).

My high blood pressure is not under control.

I have a platelet disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Niraparib maintenance therapy for up to 24 cycles, 28 days per cycle

22 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Niraparib

Trial Overview Niraparib is being tested to see if it can help treat ovarian cancer by preventing cancer cells from fixing their genes, which may slow down or stop their growth and spread.

How Is the Trial Designed?

Group I: Niraparib Maintenance Group Experimental Treatment 1 Intervention

Participants in this group will receive Niraparib maintenance therapy for up to 24 cycles, 28 days per cycle. Participants will be followed for up to one (1) year after completion of Niraparib therapy. Total participation is about three years.

Niraparib is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Zejula for:

• Maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
• Maintenance treatment of adults with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy

Approved in United States as Zejula for:

• Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
• Treatment of adults with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status

Approved in Canada as Zejula for:

• Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

GlaxoSmithKline

Industry Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Citations

1. onclive.com onclive.com/view/dr-elias-on-outcomes-with-niraparib-maintenance-therapy-in-ovarian-cancer

Dr Elias on Outcomes With Niraparib Maintenance Therapy ... “The primary outcome was progression-free survival. For women randomized to olaparib, the chances of progression or death were reduced by ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10663182/

Efficacy and Safety of Niraparib as First-Line Maintenance ... The results of HRD testing revealed that 66 (33.2%) patients were positive, 52 (26.1%) negative, and 81 (40.7%) not known. It is noteworthy that ...

3. zejulahcp.com zejulahcp.com/efficacy/

PRIMA Clinical Study | Efficacy | ZEJULA (niraparib) for HCPs ZEJULA was associated with long-term PFS benefits for patients with HRD-positive ovarian cancer.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.5587

Efficacy of niraparib in patients with advanced ovarian cancer Conclusions: Niraparib improves PFS and lowers the time to first subsequent therapy in patients with advanced ovarian cancer. Outcomes and ...

5. facingourrisk.org facingourrisk.org/XRAY/PARP-inhibitor-ovarian-cancer-survival

Niraparib improves outcomes in patients with newly ... Women who received niraparib had a longer progression-free survival (amount of time until their cancer came back or got worse) than those who received a placebo

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11202616/

Real-World Safety of Niraparib for Maintenance Treatment of ... We identified 749 patients who received niraparib for maintenance treatment of newly diagnosed or recurrent ovarian cancer between 2019 and 2022 ...

7. zejulahcp.com zejulahcp.com/safety/

Safety & Side Effects| ZEJULA (niraparib) for HCPs An established safety and tolerability profile in 1L maintenance therapy of HRD-positive advanced ovarian cancer.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211525000466

Safety of niraparib-based regimens in patients with ovarian ... Our meta-analysis suggests that niraparib is associated with a tolerable safety profile in ovarian cancer maintenance treatment, with hematological toxicities ...

9. cda-amc.ca cda-amc.ca/sites/default/files/pdf/htis/2024/OS0002-Niraparib-Report.pdf

The Safety of Niraparib in Ovarian Cancer This study aims to determine whether the safety profile of niraparib in real-world patient populations differs from the clinical trial findings.

10. annalsofoncology.org annalsofoncology.org/article/S0923-7534%2824%2903762-1/fulltext

final overall survival results from the PRIMA/ENGOT-OV26/ ... Long-term safety findings were consistent with the known safety profile of niraparib; no new safety signals were observed. Abstract. Background.