Niraparib for Ovarian Cancer
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.12345
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.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Niraparib maintenance therapy for up to 24 cycles, 28 days per cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
1
Treatment groups
Experimental Treatment
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:
- 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
- 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
- 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
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
GlaxoSmithKline
Industry Sponsor
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-cancerDr 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 ...
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 ...
PRIMA Clinical Study | Efficacy | ZEJULA (niraparib) for HCPs
ZEJULA was associated with long-term PFS benefits for patients with HRD-positive ovarian cancer.
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 ...
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
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 ...
Safety & Side Effects| ZEJULA (niraparib) for HCPs
An established safety and tolerability profile in 1L maintenance therapy of HRD-positive advanced ovarian cancer.
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 ...
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.
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.
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