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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 must have histologically diagnosed high-grade serous or endometrioid, or high-grade predominantly serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is Stage III or IV according to Federation Internationale de Gynécologie et d'Obstétrique (FIGO) criteria
Participants with inoperable Stage III and IV disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 34 months
Awards & highlights
Pivotal Trial

Study 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.Check my eligibility
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.See study design
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 advanced ovarian, fallopian tube, or peritoneal cancer.
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My cancer is at an advanced stage and cannot be removed by surgery.
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My Stage IV cancer can be operated on.
Select...
I have stage III or IV cancer and received chemotherapy and surgery to reduce the tumor.
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I have stage III cancer and still have visible cancer after initial surgery.
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I have received chemotherapy directly into my abdomen.
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I have had between 6 and 9 rounds of platinum-based chemotherapy.
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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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My doctor says my cancer responded well after 3 or more treatment cycles.
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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.
Select...
I started my last chemotherapy cycle less than 12 weeks ago.
Select...
I agree to have my tumor tested for HRD.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival
Secondary outcome measures
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 outcome measures
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%
Alkaline phosphatase increased
30%
Anemia
26%
Weight loss
22%
Dyspnea
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Creatinine increased
17%
Platelet count decreased
17%
Mucositis oral
13%
Sinus tachycardia
13%
Vomiting
13%
Aspartate aminotransferase increased
13%
Rash maculo-papular
9%
Urinary tract infection
9%
Back pain
9%
Dehydration
9%
Blood bilirubin increased
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Dry mouth
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Neutrophil count decreased
4%
Edema limbs
4%
Esophageal ulcer
4%
Depression
4%
Hyperkalemia
4%
Hypokalemia
4%
Lung infection
4%
Sore throat
4%
Skin tear
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Leukocytosis
4%
White blood cell decreased
4%
Syncope
4%
Itchy eyes
4%
Hyponatremia
4%
Flu like symptoms
4%
Postnasal drip
4%
Hypotension
4%
Hoarseness
4%
Sinus pain
4%
Bloating
4%
Diarrhea
4%
Head injury
4%
Oral petechia
4%
Peripheral sensory neuropathy
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Upper respiratory infection
4%
Tremor
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
~1560

Find a Location

Who is running the clinical trial?

Tesaro, Inc.Lead Sponsor
56 Previous Clinical Trials
9,817 Total Patients Enrolled
Gynecologic Oncology GroupNETWORK
250 Previous Clinical Trials
70,193 Total Patients Enrolled
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
35 Previous Clinical Trials
15,906 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

Frequently Asked Questions

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

What is the long-term prognosis of patients who take Niraparib?

"Niraparib's safety is based on its classification as a Phase 3 trial and the available data supporting its efficacy and safety."

Answered by AI

How many candidates are being offered participation in this research project?

"Unfortunately, this study is not currently looking for participants. As indicated on clinicaltrials.gov, this study was first posted on July 7th, 2016 and was last updated on July 13th, 2022. If you are interested in other trials, 551 studies for patients with ovary cancer and 97 studies involving Niraparib are currently enrolling patients."

Answered by AI

Are there any other precedents for Niraparib clinical trials?

"There are 97 Niraparib clinical trials currently underway. Of these, 13 are in the final Phase 3. The majority of these trials take place in Washington, D.C., but there are 2646 total locations for these studies."

Answered by AI

At how many different locations is this research project currently taking place?

"With 70 active recruitment sites, this study has a large geographical footprint. Patients can minimize travel burdens by selecting a clinic near to their location from the list of participating locations which include London, Surrey, Teaneck, and other sites."

Answered by AI

Is this a new or innovative way to test this medical treatment?

"Since 2016, Niraparib has been under investigation in 97 clinical trials spanning 478 cities and 49 countries. The initial study, sponsored by Myriad Genetics, Inc., was completed in 2016 with 733 participants. Following the Phase 3 approval process, Niraparib became a commercially available medication."

Answered by AI
Recent research and studies
~85 spots leftby Feb 2025