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PARP Inhibitor
Alternative Dosing of Niraparib for Ovarian Cancer
Phase 2
Recruiting
Led By Dr. Allan Covens, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be female and age >/= 18 years of age
Newly diagnosed, histologically confirmed, high-grade serous and grade 3 endometrioid ovarian, primary peritoneal, or fallopian tube cancer undergoing frontline treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will test a new way of giving a drug to ovarian cancer patients to see if it improves their prognosis.
Who is the study for?
This trial is for women over 18 with newly diagnosed high-grade ovarian cancer who've completed certain chemotherapies. They must be post-menopausal, surgically sterilized, or use contraception. Exclusions include pregnancy, previous severe reactions to niraparib or PARP inhibitors, and certain health conditions.Check my eligibility
What is being tested?
The trial tests alternative dosing of Niraparib in patients with advanced stage ovarian cancer to see how it affects the rate of side effects, treatment interruptions, dose reductions/discontinuations and progression-free survival at 24 months.See study design
What are the potential side effects?
Potential side effects may include blood disorders (like low counts leading to increased infection risk), fatigue, hypertension that needs control before starting treatment. Patients should not have had persistent severe side effects from prior treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman and at least 18 years old.
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I have been newly diagnosed with a specific type of advanced ovarian, peritoneal, or fallopian tube cancer.
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My cancer is stage III or IV, and I am receiving chemotherapy before surgery.
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I can take pills by mouth.
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My cancer responded well to platinum-based treatment, with no tumor larger than 1cm.
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I have completed at least 4 rounds of platinum-based chemotherapy.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of thrombocytopenia
Secondary outcome measures
Incidence of discontinuation due to disease progression
Incidence of discontinuation due to other hematologic toxicity
Incidence of discontinuation due to other toxicities
+8 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: Single arm- NiraparibExperimental Treatment1 Intervention
Oral niraparib will be administered in a dose escalation design where patients will start at a dose of 100 mg PO daily for the first two cycles, then 200 mg PO daily for the third and fourth cycle. Patients will remain on the individualized dose until either they experience an adverse event and require a dose reduction or they have disease progression.
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?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,267 Total Patients Enrolled
2 Trials studying Ovarian Cancer
236 Patients Enrolled for Ovarian Cancer
GlaxoSmithKlineIndustry Sponsor
4,755 Previous Clinical Trials
8,070,795 Total Patients Enrolled
23 Trials studying Ovarian Cancer
16,410 Patients Enrolled for Ovarian Cancer
Dr. Allan Covens, MDPrincipal InvestigatorSunnybrook Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 30 days.I have a serious heart condition.You have taken another experimental treatment within the past 4 weeks or 5 times the length of time it takes for the treatment to leave your body, whichever is longer.I am not taking any medications that are not allowed in the study.I had major surgery more than 3 weeks ago and have recovered.My organs are functioning well enough for me to join the trial.I do not have active liver or biliary disease, except for stable conditions as assessed.I have stomach or intestine problems that could affect how my body absorbs medicine.I am getting regular blood tests to meet the trial's requirements.You are currently participating in another research study.Your heart takes too long to recharge between beats, which can be dangerous.I have had PRES in the past.I am a woman and at least 18 years old.I have been newly diagnosed with a specific type of advanced ovarian, peritoneal, or fallopian tube cancer.If you can have children, you need to have a negative pregnancy test within 3 days before starting the study treatment.I have had severe blood-related side effects or extreme tiredness from past cancer treatment.My cancer is stage III or IV, and I am receiving chemotherapy before surgery.I am under 18 years old.You are allergic to niraparib or any of its parts.I have been treated with or participated in a trial involving PARP inhibitors.I plan to donate blood during or within 90 days after the study.I have a serious health condition that is not well-controlled.I am receiving blood transfusions to qualify for this trial.I have a weakened immune system, but I haven't had my spleen removed.I finished chemotherapy less than 12 weeks ago.I am post-menopausal, surgically sterilized, or will use birth control and not donate eggs until 6 months after treatment ends.I have a history or risk of blood disorders like myelodysplastic syndrome or leukemia.I had fluid removed from my abdomen within the last 4 weeks.My high blood pressure is under control with treatment.I can take pills by mouth.I do not have uncontrolled brain or spinal cord cancer spread.I have HIV and am at high risk for serious health issues.I haven't had any cancer other than ovarian or non-serious skin cancer in the last 2 years.I haven't had extensive bone marrow radiation in the last 2 weeks or any radiation in the last week.I have not had a blood transfusion in the last 4 weeks.I have a known BRCA1 or BRCA2 gene mutation.My cancer responded well to platinum-based treatment, with no tumor larger than 1cm.Your CA-125 levels need to be normal, or they must have decreased by 90% during the first treatment and stayed stable for at least 7 days (not increasing by more than 15%).I do not have any health issues that could interfere with the study.I have completed at least 4 rounds of platinum-based chemotherapy.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: Single arm- 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.
Are there any possible risks associated with using Niraparib in a one-arm trial?
"The safety of niraparib, a single-arm drug, was rated at 2 by the Power team. This is because Phase 2 trials only have limited data attesting to its security but no evidence yet for efficacy."
Answered by AI
Has recruitment for this trial commenced?
"The clinical trial originally posted on September 1st 2023 is no longer actively recruiting, as per the information available from clinicaltrials.gov. Despite that, there are still over 700 other studies which require participants at this current moment in time."
Answered by AI
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