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Niraparib + Bevacizumab for Advanced Ovarian Cancer
Study Summary
This trial will test the safety and efficacy of niraparib, an oral inhibitor of PARP-1 and PARP-2, when combined with bevacizumab as maintenance treatment for advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 37 Patients • NCT03207347Trial Design
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- I agree to have HRD testing on my tumor.I have a serious health condition that is not well-controlled.I have a higher risk of bleeding due to other health conditions.My ovarian cancer is high-grade serous or endometrioid, with or without certain genetic mutations.I finished my initial chemotherapy with good response and will start the study treatment within 3 months.I have had one surgery to remove as much cancer as possible.My ovarian tumor is not from the surface layer and is low grade or from germ cells.I have a serious heart condition.I have had issues with bowel blockage or serious abdominal infections.I have or had myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML).My organs are functioning well.I have been treated with a PARP inhibitor before.I have not had or been treated for any cancer other than ovarian in the last 5 years.I am postmenopausal, surgically sterilized, or will avoid pregnancy during the study.I am fully active or restricted in physically strenuous activity but can do light work.I've had at least 3 treatments with bevacizumab and platinum-based chemo, or 2 if I had surgery.My CA-125 levels are normal or have dropped by more than 90% and stayed low for over a week.I can take medicine by mouth.My immune system is weak.I am a woman, 18 or older, and agree to participate in the study.I have been diagnosed with advanced ovarian, fallopian tube, or peritoneal cancer and have recovered from surgery.My blood pressure is normal or well-controlled with medication.Your heart's QT interval is longer than 480 milliseconds.I cannot take PARP or VEGF inhibitors due to adverse reactions.I have an active liver disease such as hepatitis B or C.I do not have stomach or intestine problems affecting medication absorption.You have high levels of protein in your urine.
- Group 1: Participants receiving niraparib+ bevacizumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What condition is Niraparib usually utilized to address?
"Patients with malignant growths, recurrent platinum-sensitive primary peritoneal cancer, and Stage IV epithelial ovarian cancer after initial surgical excision can benefit from Niraparib therapy."
Has Niraparib been authorized by the Food and Drug Administration?
"Niraparib's safety has been attested to through Phase 2 trials, thus it earned a score of 2 on our scale. However, the efficacy of this treatment has yet to be sufficiently demonstrated."
Could you elucidate on other experiments that have included Niraparib?
"Back in 2004, Niraparib was first investigated at Memorial Sloan Kettering Basking Ridge (Follow Up Only). Since then, 1027 clinical trials have been concluded. 446 separate studies are still ongoing, with a considerable amount of them centered around Englewood, New jersey."
What are the core goals this clinical trial is trying to achieve?
"The primary outcome of this 18 month trial will be the Progression Free Survival (PFS) Rate. Secondary metrics include Number of participants with abnormal vital signs, Change from Baseline in Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI) - Patient Reported Outcome (PRO), and finally, Number of participants with dose reduction due to Adverse Events."
How many healthcare establishments are administering this research in the metropolis?
"The trial is currently operational in 28 medical centres - including Englewood, Lebanon and Providence - so participants are encouraged to choose the site that's closest to them. This will help reduce commuting needs if they decide to join."
How much interest has been generated in this research endeavor?
"Unfortunately, this clinical trial is not presently accepting candidates. First posted on December 12th 2017, the study has since been edited for the last time on November 23rd 2021. However, if you are looking to join a medical trial related to ovarian cancer there are currently 535 active studies and 446 trials focusing on Niraparib that require participants."
Is recruitment of participants still underway for this experiment?
"Currently, this clinical trial is not actively recruiting participants. After first being posted on December 12th 2017 and most recently updated on November 23rd 2022, there are no open roles available at the moment. However, if you're interested in other studies related to ovarian cancer or Niraparib treatments specifically, 535 and 446 trials respectively are seeking new enrolments."
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