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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
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 belowSelect...
I have received chemotherapy directly into my abdomen.
Select...
My CA-125 levels are normal or have dropped by more than 90% and stayed stable for at least a week.
Select...
I agree to have my tumor tested for HRD.
Select...
My Stage IV cancer can be operated on.
Select...
My doctor says my cancer responded well after 3 or more treatment cycles.
Select...
My cancer is at an advanced stage and cannot be removed by surgery.
Select...
I have stage III cancer and still have visible cancer after initial surgery.
Select...
I've had at least 2 rounds of platinum-based therapy after surgery to remove my cancer.
Select...
I have advanced ovarian, fallopian tube, or peritoneal cancer.
Select...
I have had between 6 and 9 rounds of platinum-based chemotherapy.
Select...
I have stage III or IV cancer and received chemotherapy and surgery to reduce the tumor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 34 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 34 months
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 moreOther 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 moreSide effects data
From 2022 Phase 2 trial • 37 Patients • NCT0320734774%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Anemia
30%
Alkaline phosphatase increased
26%
Weight loss
22%
Dyspnea
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Platelet count decreased
17%
Mucositis oral
17%
Creatinine increased
13%
Sinus tachycardia
13%
Vomiting
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Dehydration
9%
Blood bilirubin increased
9%
Urinary tract infection
9%
Dry mouth
9%
Back pain
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Esophageal ulcer
4%
Skin tear
4%
Diarrhea
4%
Edema limbs
4%
Leukocytosis
4%
Syncope
4%
Head injury
4%
Oral petechia
4%
Sinus pain
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Itchy eyes
4%
Flu like symptoms
4%
Hoarseness
4%
Peripheral sensory neuropathy
4%
Sore throat
4%
Upper respiratory infection
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Hypotension
4%
Hyponatremia
4%
Hypokalemia
4%
Depression
4%
Postnasal drip
4%
Hyperkalemia
4%
Bloating
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B
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
~1540
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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received chemotherapy directly into my abdomen.My CA-125 levels are normal or have dropped by more than 90% and stayed stable for at least a week.I agree to have my tumor tested for HRD.My Stage IV cancer can be operated on.My doctor says my cancer responded well after 3 or more treatment cycles.I have stage III or IV cancer and received chemotherapy and surgery to reduce the tumor.My cancer is at an advanced stage and cannot be removed by surgery.I have stage III cancer and still have visible cancer after initial surgery.I've had at least 2 rounds of platinum-based therapy after surgery to remove my cancer.I started my last chemotherapy cycle less than 12 weeks ago.I have advanced ovarian, fallopian tube, or peritoneal cancer.I have had between 6 and 9 rounds of platinum-based chemotherapy.If you can have a baby, you need to have a test that shows you are not pregnant before starting the study treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Participants receiving Niraparib
- Group 2: Participants receiving Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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
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