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Niraparib Maintenance Therapy for Endometrial Cancer

Phase 2
Recruiting
Led By Marina Frimer, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically diagnosed Uterine Serous Carcinoma
Female, age at least 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing Niraparib as a maintenance treatment for advanced or recurrent USC, with the aim of finding out if it is effective and safe.

Who is the study for?
This trial is for women aged 18 or older with advanced stage uterine serous carcinoma (USC) who have responded to chemotherapy. They must not be breastfeeding, agree to contraception if of childbearing potential, and have good organ function. Those with persistent severe blood disorders from past treatments, recent major surgery, uncontrolled medical conditions, active infections, or prior PARP inhibitor treatment are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of Niraparib as a maintenance therapy in patients with USC who've had a positive response to platinum-based chemotherapy. The goal is to see if taking Niraparib after chemo helps control cancer growth better than the current standard care.See study design
What are the potential side effects?
Niraparib may cause side effects such as fatigue, low blood cell counts leading to increased infection risk or anemia, nausea or vomiting, constipation or diarrhea, heart palpitations and possible allergic reactions among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a type called Uterine Serous Carcinoma.
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I am a woman aged 18 or older.
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My tumor has responded to at least 3 cycles of chemotherapy.
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I will start Niraparib within 12 weeks after my last chemotherapy or 14 weeks if I had radiation.
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I am not pregnant and agree to avoid pregnancy during the study.
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I have had a hysterectomy, both ovaries removed, or my tubes tied.
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I agree to have the Foundation One genetic test.
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I am over 45 and have not had a period for more than a year.
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I am currently on my first or second round of chemotherapy for cancer that has come back.
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My cancer responded to initial platinum-based treatment and didn't worsen for over 6 months.
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I have been on a stable dose of corticosteroids for at least 4 weeks.
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My kidney function, measured by creatinine levels, is within the normal range.
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I agree not to donate blood during and for 3 months after the study.
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I can take pills by mouth.
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My cancer is advanced uterine serous carcinoma (stage III, IV, or recurrent and responds to platinum).
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My organs are functioning well.
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I can do most of my daily activities by myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Mutational burden
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
ORR
+3 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%
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%
Urinary tract infection
9%
Dehydration
9%
Back pain
9%
Blood bilirubin increased
9%
Dry mouth
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%
Hypotension
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%
Depression
4%
Hyponatremia
4%
Hypokalemia
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

1Treatment groups
Experimental Treatment
Group I: NiraparibExperimental Treatment1 Intervention
Oral niraparib -Cohort - Uterine serous carcinoma
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?

Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,888 Total Patients Enrolled
1 Trials studying Uterine Carcinoma
Tesaro, Inc.Industry Sponsor
56 Previous Clinical Trials
10,511 Total Patients Enrolled
Marina Frimer, MDPrincipal Investigator - Northwell Health
Bronx Children's Psychiatric Center, Forest Hills Hospital, Glen Cove Hospital-Mildred & Frank Feinberg Campus, The, Huntington Hospital, Long Island Jewish Medical Center, North Shore University Hospital, North Shore University Hospital at Syosset, Peconic Bay Medical Center, Southside Hospital
1 Previous Clinical Trials
4 Total Patients Enrolled

Media Library

Niraparib Clinical Trial Eligibility Overview. Trial Name: NCT04080284 — Phase 2
Uterine Carcinoma Research Study Groups: Niraparib
Uterine Carcinoma Clinical Trial 2023: Niraparib Highlights & Side Effects. Trial Name: NCT04080284 — Phase 2
Niraparib 2023 Treatment Timeline for Medical Study. Trial Name: NCT04080284 — Phase 2

Frequently Asked Questions

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

How does the safety profile of Niraparib compare to other treatments?

"Niraparib has been given a Phase 2 safety rating by our team at Power. This is based on some evidence of safety in earlier trials, but no efficacy data."

Answered by AI

Is this trial only happening in Canada or are there other countries involved as well?

"Currently, this trial is enrolling patients from 5 different sites. While 2 of the sites are localised to New york, the other 3 are based in Greenlawn, New Brunswick and 5 additional sites. If you are considering enrolling in this study, please choose the site that is most proximal to your home to reduce travel costs and time."

Answered by AI

Are there other similar experiments to this one that have yielded similar results?

"According to information available, 97 different clinical trials involving Niraparib are currently underway in 49 countries and 478 cities. The first study began in 2016. That trial, which was sponsored by Myriad Genetics, Inc., completed its Phase 3 drug approval stage in 2016 after enrolling 733 patients. Since then, 18 additional studies have completed."

Answered by AI

Could you share how many people have signed up for this experiment?

"That is correct, the study is still searching for participants. The 5 sites are recruiting a total of 45 patients. The trial was posted on December 30th, 2019 and was updated most recently on March 17th, 2022."

Answered by AI

Does this therapy have a precedent?

"GSK Investigational Site first began studying niraparib in 2016 and 18 completed studies exist. At the moment, there are 97 clinical trials underway with numerous trial sites throughout New york and New jersey."

Answered by AI
Recent research and studies
~2 spots leftby Jul 2024