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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
Must not have
Participant is immunocompromised
Participants with ovarian tumors of non-epithelial origin (eg, germ cell tumor) or any low grade tumors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
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 belowSelect...
I agree to have HRD testing on my tumor.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have had one surgery to remove as much cancer as possible.
Select...
My CA-125 levels are normal or have dropped by more than 90% and stayed low for over a week.
Select...
I can take medicine by mouth.
Select...
I have been diagnosed with advanced ovarian, fallopian tube, or peritoneal cancer and have recovered from surgery.
Select...
My blood pressure is normal or well-controlled with medication.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My immune system is weak.
Select...
My ovarian tumor is not from the surface layer and is low grade or from germ cells.
Select...
I have a serious heart condition.
Select...
I have had issues with bowel blockage or serious abdominal infections.
Select...
I have or had myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML).
Select...
I have been treated with a PARP inhibitor before.
Select...
I cannot take PARP or VEGF inhibitors due to adverse reactions.
Select...
I have an active liver disease such as hepatitis B or C.
Select...
I do not have stomach or intestine problems affecting medication absorption.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
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 moreSide effects data
From 2022 Phase 2 trial • 37 Patients • NCT0320734774%
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%
Vomiting
13%
Sinus tachycardia
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
9%
Back pain
9%
Alanine aminotransferase increased
9%
Blood bilirubin increased
9%
Non-cardiac chest pain
9%
Anxiety
9%
Dry mouth
9%
Cough
9%
Urinary tract infection
9%
Hypertension
9%
Dehydration
4%
Hyperkalemia
4%
Head injury
4%
Bloating
4%
Unknown infection
4%
Hyponatremia
4%
Syncope
4%
Ascites
4%
Hoarseness
4%
Upper respiratory infection
4%
Lung infection
4%
Tremor
4%
White blood cell decreased
4%
Hypotension
4%
Sinus pain
4%
Diarrhea
4%
Esophageal ulcer
4%
Hypokalemia
4%
Skin tear
4%
Sore throat
4%
Leukocytosis
4%
Flu like symptoms
4%
Neutrophil count decreased
4%
Peripheral sensory neuropathy
4%
Bruising
4%
Postnasal drip
4%
Hematuria
4%
Depression
4%
Edema limbs
4%
Hot flashes
4%
Oral petechia
4%
Hyperglycemia
4%
Itchy eyes
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
10,421 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,596 Previous Clinical Trials
6,144,175 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Participants receiving niraparib+ bevacizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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