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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
Must not have
Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
Major surgery within 3 weeks of starting the study or patient has not recovered from any effects of any major surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Select...
I am a woman aged 18 or older.
Select...
My tumor has responded to at least 3 cycles of chemotherapy.
Select...
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.
Select...
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.
Select...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have never been diagnosed with MDS or AML.
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I haven't had major surgery in the last 3 weeks or still recovering from one.
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I have a serious health condition that is not under control.
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My cancer has a high number of mutations (MSI-H).
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I haven't had treatment for cancer other than uterine or non-serious skin cancer in the last 2 years.
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I have active hepatitis.
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I have long-lasting anemia, low white blood cell or platelet counts from my last cancer treatment.
Select...
I have been treated with a PARP inhibitor before.
Select...
I had fluid removed from my abdomen during my last two chemotherapy cycles.
Select...
I have brain or spinal cord cancer that is not under control and causes symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
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%
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%
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%
Hyperkalemia
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
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~2400
Find a Location
Who is running the clinical trial?
Northwell HealthLead Sponsor
474 Previous Clinical Trials
469,115 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.
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