Niraparib Maintenance Treatment for Ovarian Cancer

Not currently recruiting at 236 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Tesaro, Inc.

Must be taking: Platinum-based therapy

Must not be taking: PARP inhibitors, Bevacizumab

Disqualifiers: Mucinous cancer, Clear cell cancer, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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: Up to 34 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of Niraparib, a maintenance treatment, for individuals with Stage III or IV ovarian cancer. It targets those who have completed an initial round of platinum-based chemotherapy and have shown some positive response. The trial includes two groups: one receiving Niraparib and the other a placebo. Ideal participants have high-grade serous or endometrioid ovarian cancer with visible disease remaining after surgery or have undergone specific types of chemotherapy. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are receiving bevacizumab as maintenance treatment or have had recent investigational therapy, you may not be eligible to participate.

Is there any evidence suggesting that Niraparib is likely to be safe for humans?

A previous study involved 749 patients who took Niraparib to maintain their health after ovarian cancer treatment from 2019 to 2022. This research focused on safety and found that Niraparib was generally well-tolerated. Some patients experienced side effects such as nausea and fatigue, but these were manageable for most. Another study demonstrated that starting Niraparib soon after chemotherapy helped patients live longer without cancer progression, with no unexpected safety issues. While Niraparib is approved for maintaining health after ovarian cancer treatment, discussing any concerns or side effects with a doctor remains important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ovarian cancer?

Niraparib is unique because it targets cancer cells in a different way compared to standard treatments for ovarian cancer, like chemotherapy and surgery. Most treatments work by killing all rapidly dividing cells, but Niraparib is a PARP inhibitor, which specifically blocks an enzyme cancer cells use to repair their DNA. This means Niraparib is particularly effective at targeting cancer cells while sparing more healthy cells, potentially leading to fewer side effects. Researchers are excited because this targeted approach could improve patient outcomes and quality of life compared to traditional therapies.

What evidence suggests that Niraparib might be an effective treatment for ovarian cancer?

Research shows that Niraparib, which participants in this trial may receive, can improve outcomes for patients with advanced ovarian cancer. Studies have found that women taking Niraparib experienced a longer period before their cancer worsened or returned compared to those on a placebo. Niraparib is particularly beneficial for patients who are HRD-positive, possessing specific genetic markers that enhance the treatment's effectiveness. Patients on Niraparib also experienced a delay in needing additional treatment. Overall, evidence strongly supports Niraparib as a promising ongoing treatment for ovarian cancer. ^{4 5 6 7 8}

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

This trial is for adults with advanced Stage III or IV ovarian cancer who've had a good response to initial platinum-based chemotherapy. They must have completed at least 3 cycles of therapy and be within 12 weeks post-chemo. Participants need negative pregnancy tests, agree to genetic testing of their tumor, and can't have more than 9 chemo cycles.

Inclusion Criteria

I have received chemotherapy directly into my abdomen.

My CA-125 levels are normal or have dropped by more than 90% and stayed stable for at least a week.

I agree to have my tumor tested for HRD.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Niraparib or placebo as maintenance treatment following response to front-line platinum-based chemotherapy

Up to 34 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 34 months

Long-term follow-up

Participants are monitored for overall survival and progression-free survival

Up to 7 years

What Are the Treatments Tested in This Trial?

Interventions

• Niraparib

Trial Overview The study is testing Niraparib as a maintenance treatment against a placebo in patients who responded well to first-line chemotherapy. The goal is to see if Niraparib helps keep the cancer from coming back or getting worse over the course of up to seven years.

How Is the Trial Designed?

Group I: Participants receiving Niraparib Experimental Treatment 1 Intervention

Group II: Participants receiving Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Tesaro, Inc.

Lead Sponsor

Trials

57

Recruited

10,600+

Gynecologic Oncology Group

Collaborator

Trials

251

Recruited

65,400+

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Collaborator

Trials

41

Recruited

19,200+

Myriad Genetics, Inc.

Industry Sponsor

Trials

18

Recruited

5,700+

Published Research Related to This Trial

Niraparib significantly extends progression-free survival in patients with newly diagnosed advanced ovarian cancer, showing efficacy in both homologous-recombination deficiency positive (HRd) and negative (HRp) populations, based on a phase III trial.

The treatment has a manageable safety profile, with myelosuppression as the main concern, which can be effectively managed through monitoring and individualized dosing based on weight and platelet count.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Niraparib: A Review in First-Line Maintenance Therapy in Advanced Ovarian Cancer. Lee, A.[2022]

In a Phase 2 study involving 19 Japanese patients with platinum-sensitive, relapsed ovarian cancer, niraparib at a dose of 300 mg/day was found to have a safety profile consistent with previous studies, with 31.6% of patients experiencing grade 3 or 4 thrombocytopenia-related events within 30 days of treatment.

The overall safety profile of niraparib was deemed acceptable, with common treatment-emergent adverse events including nausea and decreased blood cell counts, but no significant improvements in tumor response were observed in the small cohort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 2 single-arm study on the safety of maintenance niraparib in Japanese patients with platinum-sensitive relapsed ovarian cancer. Takehara, K., Matsumoto, T., Hamanishi, J., et al.[2021]

Niraparib significantly improves progression-free survival and other key outcomes in patients with recurrent, platinum-sensitive ovarian cancer, based on the phase III NOVA trial involving a randomized, double-blind, placebo-controlled design.

The treatment has a manageable safety profile, with most serious side effects being blood-related issues, which can be effectively managed through dose adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Niraparib: A Review in Ovarian Cancer. Heo, YA., Duggan, ST.[2019]

Niraparib, a PARP inhibitor, is recommended as a maintenance treatment for patients with platinum-sensitive relapsed ovarian cancer, leveraging the concept of synthetic lethality in BRCA mutation carriers.

A case study of a 68-year-old woman with brain metastases from high-grade serous ovarian cancer showed that she remained free of disease progression for over 17 months while on niraparib after second-line chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Niraparib as maintenance therapy in a patient with ovarian cancer and brain metastases. Gray, S., Khor, XY., Yiannakis, D.[2021]

In a Phase 2 study involving 20 Japanese women with heavily pretreated ovarian cancer, niraparib demonstrated an objective response rate of 35%, indicating that it can effectively reduce tumor size in some patients.

The treatment was generally well-tolerated, with a high disease control rate of 90%, although common side effects included anemia and nausea, and 70% of patients experienced dose reductions or interruptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 2 single-arm study on the efficacy and safety of niraparib in Japanese patients with heavily pretreated, homologous recombination-deficient ovarian cancer. Okamoto, A., Kondo, E., Nakamura, T., et al.[2021]

Niraparib, a recently approved treatment for recurrent platinum-sensitive ovarian cancer, has demonstrated a high oral bioavailability of 72.7% in humans, indicating effective absorption when taken orally.

The study involved six patients who received a therapeutic dose of 300 mg of niraparib, followed by a small intravenous dose to measure its levels in the bloodstream, confirming its potential as a convenient oral treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of the absolute oral bioavailability of niraparib by simultaneous administration of a 14C-microtracer and therapeutic dose in cancer patients. van Andel, L., Rosing, H., Zhang, Z., et al.[2019]

Niraparib is the first PARP inhibitor approved for ovarian cancer treatment in patients without BRCA mutations, showing good tolerability and manageable hematologic side effects, especially with new dose modification guidelines.

Current research is exploring niraparib's effectiveness as a maintenance therapy after platinum-based chemotherapy and in recurrent high-grade serous ovarian cancer, highlighting the need for better biomarkers to identify which patients will benefit most from this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Niraparib for the treatment of ovarian cancer. Essel, KG., Moore, KN.[2019]

Niraparib is the first FDA- and EMA-approved PARP inhibitor for maintenance therapy in platinum-sensitive ovarian cancer, effective regardless of BRCA status in first-line treatment.

The review highlights niraparib's pharmacological properties and summarizes efficacy and safety data from key trials, indicating its significant role in improving treatment outcomes for ovarian cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Niraparib and Advanced Ovarian Cancer: A Beacon in the Non-BRCA Mutated Setting. Maiorano, MFP., Maiorano, BA., Biancofiore, A., et al.[2023]

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. 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

5. 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 ...

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39448085/

Comparison of survival outcomes and safety between early ... Early initiation of niraparib maintenance therapy within 8 weeks of chemotherapy completion improved progression-free survival.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0923753424037621

Niraparib first-line maintenance therapy in patients with ... Niraparib first-line maintenance significantly prolonged progression-free survival (PFS) among patients with newly diagnosed advanced ovarian cancer.