Niraparib Maintenance Treatment for Ovarian Cancer

Recruiting at 205 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

733 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Niraparib for ovarian cancer?

Research shows that Niraparib, a drug used for maintenance treatment in ovarian cancer, significantly extends the time patients live without the disease getting worse compared to a placebo. This benefit is seen in patients regardless of specific genetic mutations, making it a promising option for many individuals with ovarian cancer. ^{1 2 3 4 5}

Is niraparib safe for use in humans?

Niraparib is generally well tolerated in humans, with manageable side effects, mainly affecting blood cells. Safety studies, including those in Japanese patients, have shown that its toxicities can be managed with dose adjustments based on weight and platelet count. ^{2 3 6 7 8}

How does the drug niraparib differ from other treatments for ovarian cancer?

Niraparib is unique because it is a PARP inhibitor used as a maintenance treatment for ovarian cancer, extending the time patients remain free from disease progression after responding to platinum-based chemotherapy. Unlike some treatments, it is effective regardless of BRCA mutation status, making it a versatile option for a broader range of patients. ^{1 3 4 5 9}

What is the purpose of this trial?

This study aims to assess efficacy of Niraparib (GSK3985771) as maintenance treatment in participants with Stage III or IV ovarian cancer. Participants must have completed front-line platinum based regimen with complete response (CR) or partial response (PR). Data collection for Secondary Outcome measures is ongoing and the approximate duration of the study will be 7 years.

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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 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]

References

1. France pubmed.ncbi.nlm.nih.gov

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

2. Korea (South) 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. [2021]

3. Germany 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. [2019]

4. France pubmed.ncbi.nlm.nih.gov

Niraparib: A Review in Ovarian Cancer. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Niraparib as maintenance therapy in a patient with ovarian cancer and brain metastases. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Niraparib and Advanced Ovarian Cancer: A Beacon in the Non-BRCA Mutated Setting. [2023]

7. Korea (South) 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Niraparib for the treatment of ovarian cancer. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Niraparib maintenance in frontline management of ovarian cancer: a cost effectiveness analysis. [2021]