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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 belowSelect...
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 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 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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My cancer is advanced uterine serous carcinoma (stage III, IV, or recurrent and responds to platinum).
Select...
I can do most of my daily activities by myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
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 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%
Sinus tachycardia
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
13%
Vomiting
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%
Flu like symptoms
4%
Leukocytosis
4%
Oral petechia
4%
Sinus pain
4%
Syncope
4%
Bruising
4%
Unknown infection
4%
Ascites
4%
Itchy eyes
4%
Hoarseness
4%
Peripheral sensory neuropathy
4%
Sore throat
4%
Upper respiratory infection
4%
Depression
4%
Edema limbs
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Hypotension
4%
Hyponatremia
4%
Head injury
4%
Hypokalemia
4%
Hyperkalemia
4%
Postnasal drip
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
460 Previous Clinical Trials
470,998 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never been diagnosed with MDS or AML.You are allergic to the ingredients in Niraparib.My cancer is a type called Uterine Serous Carcinoma.I haven't had major surgery in the last 3 weeks or still recovering from one.I am a woman aged 18 or older.I have a serious health condition that is not under control.My tumor has responded to at least 3 cycles of chemotherapy.My cancer has a high number of mutations (MSI-H).I haven't had a blood transfusion in the last 4 weeks.I will start Niraparib within 12 weeks after my last chemotherapy or 14 weeks if I had radiation.I am not pregnant and agree to avoid pregnancy during the study.I have had a hysterectomy, both ovaries removed, or my tubes tied.I haven't had treatment for cancer other than uterine or non-serious skin cancer in the last 2 years.I haven't taken any colony stimulating factors in the last 4 weeks.I have a weakened immune system, but I haven't had my spleen removed.I have active hepatitis.I agree to have the Foundation One genetic test.I am over 45 and have not had a period for more than a year.I am currently on my first or second round of chemotherapy for cancer that has come back.My cancer responded to initial platinum-based treatment and didn't worsen for over 6 months.I have been on a stable dose of corticosteroids for at least 4 weeks.My kidney function, measured by creatinine levels, is within the normal range.I agree not to donate blood during and for 3 months after the study.I can take pills by mouth.I have long-lasting anemia, low white blood cell or platelet counts from my last cancer treatment.My cancer is advanced uterine serous carcinoma (stage III, IV, or recurrent and responds to platinum).I have been treated with a PARP inhibitor before.My organs are functioning well.I haven't had certain types of radiation or new drug tests within the last month.I can do most of my daily activities by myself.I had fluid removed from my abdomen during my last two chemotherapy cycles.I have brain or spinal cord cancer that is not under control and causes symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Niraparib
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.
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
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