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Niraparib Maintenance Treatment for Ovarian Cancer

Phase 3
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
Participants who have received intraperitoneal chemotherapy
Participants must have either Cancer antigen 125 (CA-125) in the normal range or CA-125 decrease by more than 90 percent(%) during their front-line therapy that is stable for at least 7 days (no increase more than (>)15% from nadir)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 34 months
Awards & highlights
Pivotal Trial

Summary

This trial is testing if Niraparib can help treat ovarian cancer after a patient has completed a front-line platinum-based regimen. Data collection will continue for approximately 7 years.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Niraparib may cause side effects like nausea, fatigue, blood cell count changes (which could lead to anemia or infection risks), heart palpitations, insomnia, mouth sores, and constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have received chemotherapy directly into my abdomen.
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My CA-125 levels are normal or have dropped by more than 90% and stayed stable for at least a week.
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I agree to have my tumor tested for HRD.
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My Stage IV cancer can be operated on.
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My doctor says my cancer responded well after 3 or more treatment cycles.
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My cancer is at an advanced stage and cannot be removed by surgery.
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I have stage III cancer and still have visible cancer after initial surgery.
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I've had at least 2 rounds of platinum-based therapy after surgery to remove my cancer.
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I have advanced ovarian, fallopian tube, or peritoneal cancer.
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I have had between 6 and 9 rounds of platinum-based chemotherapy.
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I have stage III or IV cancer and received chemotherapy and surgery to reduce the tumor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 34 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 34 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival
Secondary study objectives
Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer Module (EORTC-QLQ-OV28)
Change From Baseline in Global Health Status/QoL of EORTC-QLQ-C30
+7 more
Other study objectives
Area Under the Curve (AUC) From 0 to the Last Quantifiable Concentration (AUC[0-last])
Number of Participants With Any Non-serious Adverse Event (Non-SAE) or Any SAE
Number of Participants With Positive HRD Test
+1 more

Side effects data

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Participants receiving NiraparibExperimental Treatment1 Intervention
Group II: Participants receiving PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~2400

Find a Location

Who is running the clinical trial?

Tesaro, Inc.Lead Sponsor
56 Previous Clinical Trials
9,823 Total Patients Enrolled
Gynecologic Oncology GroupNETWORK
250 Previous Clinical Trials
64,448 Total Patients Enrolled
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
39 Previous Clinical Trials
17,473 Total Patients Enrolled

Media Library

Niraparib Clinical Trial Eligibility Overview. Trial Name: NCT02655016 — Phase 3
Ovarian Tumors Research Study Groups: Participants receiving Niraparib, Participants receiving Placebo
Ovarian Tumors Clinical Trial 2023: Niraparib Highlights & Side Effects. Trial Name: NCT02655016 — Phase 3
Niraparib 2023 Treatment Timeline for Medical Study. Trial Name: NCT02655016 — Phase 3
~79 spots leftby Nov 2025
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