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Monoclonal Antibodies

Niraparib + Bevacizumab for Advanced Ovarian Cancer

Phase 2
Waitlist Available
Research Sponsored by Tesaro, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must agree to undergo tumor HRD testing at screening
Participant must have an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

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.

Who is the study for?
This trial is for women over 18 with advanced ovarian, fallopian tube, or primary peritoneal cancer who've responded to initial chemotherapy and can take oral meds. They must have had surgery, be able to do surveys, and use birth control if of childbearing potential. Exclusions include digestive issues affecting drug absorption, certain blood diseases, prior PARP inhibitor treatment, other recent cancers, serious health problems unrelated to cancer or active infections.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of niraparib (a PARP inhibitor) combined with bevacizumab as a maintenance therapy in patients after successful first-line chemo. Participants will receive this combo for up to three years or until disease progression or unacceptable side effects occur.See study design
What are the potential side effects?
Potential side effects may include high blood pressure from bevacizumab; fatigue; nausea; bone marrow suppression leading to anemia or infection risks from niraparib; heart rhythm changes; liver issues; increased risk of bleeding due to VEGF inhibitors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to have HRD testing on my tumor.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have had one surgery to remove as much cancer as possible.
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My CA-125 levels are normal or have dropped by more than 90% and stayed low for over a week.
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I can take medicine by mouth.
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I have been diagnosed with advanced ovarian, fallopian tube, or peritoneal cancer and have recovered from surgery.
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My blood pressure is normal or well-controlled with medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS) Rate
Secondary outcome measures
Change From Baseline in Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI)
Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs)
Number of Participants With TEAEs Leading to Niraparib Dose Reductions
+6 more

Side effects data

From 2022 Phase 2 trial • 37 Patients • NCT03207347
74%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Alkaline phosphatase increased
30%
Anemia
26%
Weight loss
22%
Abdominal pain
22%
Dyspnea
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Platelet count decreased
17%
Mucositis oral
17%
Creatinine increased
13%
Sinus tachycardia
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
13%
Vomiting
9%
Dehydration
9%
Blood bilirubin increased
9%
Urinary tract infection
9%
Dry mouth
9%
Anxiety
9%
Back pain
9%
Alanine aminotransferase increased
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Sinus pain
4%
Skin tear
4%
Oral petechia
4%
Syncope
4%
Bruising
4%
Leukocytosis
4%
Ascites
4%
Itchy eyes
4%
Hoarseness
4%
Peripheral sensory neuropathy
4%
Sore throat
4%
Upper respiratory infection
4%
Edema limbs
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Hypotension
4%
Hyponatremia
4%
Diarrhea
4%
Esophageal ulcer
4%
Head injury
4%
Hypokalemia
4%
Postnasal drip
4%
Hyperkalemia
4%
Bloating
4%
Flu like symptoms
4%
Hot flashes
4%
Tremor
4%
Hyperglycemia
4%
Hematuria
4%
Depression
4%
Unknown infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants receiving niraparib+ bevacizumabExperimental Treatment2 Interventions
Participants will be administered bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute (min) intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib will be administered orally once a day continuously throughout each 21-day cycle (84-day cycle after amendment 2). On Day 1 of each cycle, niraparib will be administered upon completion of bevacizumab infusion. The starting dose of niraparib will be based on the participant's Baseline actual body weight or platelet count.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~1540
Bevacizumab
2013
Completed Phase 4
~5280

Find a Location

Who is running the clinical trial?

Tesaro, Inc.Lead Sponsor
56 Previous Clinical Trials
10,449 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,596 Previous Clinical Trials
6,144,234 Total Patients Enrolled

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03326193 — Phase 2
Ovarian Tumors Research Study Groups: Participants receiving niraparib+ bevacizumab
Ovarian Tumors Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT03326193 — Phase 2
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03326193 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
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~14 spots leftby May 2025