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PARP Inhibitor
Niraparib for Brain Cancer
Phase 2
Recruiting
Led By Priscilla Brastianos, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of triple negative breast cancer or ovarian cancer, or any cancer histology with the presence of alteration in BRCA1, BRCA2, PARP metabolism, DNA repair pathways and HRD (homologous recombination deficiency) genes in the metastatic site as described in Section 9.2 using a CLIA-certified assay
Tissue from a prior craniotomy or biopsy for clinical genetic sequencing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is being done to see how effective niraparib is against cancer that has metastasized to the central nervous system (CNS).
Who is the study for?
This trial is for adults with solid tumors that have spread to the brain and are minimally symptomatic. Participants must have measurable CNS disease, be stable on medications, and not have had recent major surgery or blood transfusions. They should not have been treated with PARP inhibitors before and must not be pregnant or breastfeeding. A good performance status and normal organ function are required.Check my eligibility
What is being tested?
The effectiveness of niraparib, a drug designed to combat cancer in the central nervous system (CNS), is being tested. The study focuses on patients whose cancer has metastasized to the CNS, particularly those with genetic alterations related to DNA repair pathways.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 bleeding problems, nausea, constipation or diarrhea, heart palpitations, insomnia, dizziness and dry mouth.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is triple negative or has specific genetic changes.
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I have had brain surgery or a biopsy for genetic testing.
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My organ and bone marrow functions are normal.
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I am older than 18 years.
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I can care for myself but may not be able to do active work.
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My brain or spinal cord cancer is getting worse.
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My cancer diagnosis was confirmed through tissue or cell analysis.
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I have a brain lesion that is at least 10 mm big.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intracranial Clinical benefit rate
Secondary outcome measures
Extracranial clinical benefit rate
Extracranial disease progression
Intracranial disease progression
+2 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%
Back pain
9%
Dehydration
9%
Blood bilirubin increased
9%
Urinary tract infection
9%
Dry mouth
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%
Postnasal drip
4%
Hypokalemia
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
Participants will receive niraparib 1x daily for each 28 day study treatment cycle up to 2 years or until disease worsens or unacceptable side effects occur.
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?
Massachusetts General HospitalLead Sponsor
2,932 Previous Clinical Trials
13,198,477 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,753 Previous Clinical Trials
8,069,668 Total Patients Enrolled
Priscilla Brastianos, MDPrincipal InvestigatorMassachusetts General Hospital
6 Previous Clinical Trials
485 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had significant radiation therapy affecting my bone marrow recently.My cancer is triple negative or has specific genetic changes.I haven't taken any colony stimulating factors in the last 4 weeks.I have had brain surgery or a biopsy for genetic testing.I agree not to donate blood during the study or for 90 days after the last treatment.I have been treated with a PARP inhibitor before.I do not have any serious, uncontrolled illnesses or infections.I have never had myelodysplastic syndrome or acute myeloid leukemia.I haven't had a blood transfusion in the last 4 weeks.I haven't been treated for any cancer other than my current one in the last 2 years.I am not pregnant and agree to avoid pregnancy during the study.I haven't had chemotherapy, immunotherapy, or radiotherapy in the last 2 weeks and have no ongoing major side effects from previous treatments.My organ and bone marrow functions are normal.I am older than 18 years.I can care for myself but may not be able to do active work.I've had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.I haven't had major surgery in the last 3 weeks and have recovered from any surgery effects.My brain or spinal cord cancer is getting worse.I have brain metastases but have had stable or no symptoms for at least 7 days.I can continue taking my current medications.My cancer diagnosis was confirmed through tissue or cell analysis.I have been on a stable dose of corticosteroids for at least a week.My cancer outside the brain is getting worse but I can still participate.I have a brain lesion that is at least 10 mm big.
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.
Have earlier studies been conducted on the impact of Niraparib?
"Presently, 99 Niraparib clinical trials are ongoing with 13 in a Phase 3 status. Most of these investigations have been set up in Washington D.C., but there is also 2817 locations conducting such research around the world."
Answered by AI
How many individuals are currently enrolled in this experiment?
"Affirmative, clinicaltrials.gov supports that this investigation is still searching for trialists. This project was originally published on January 28th 2022 and afterwards updated the same day. Presently seeking 20 subjects across 3 facilities."
Answered by AI
Has Niraparib been certified by the FDA?
"Our analysts at Power assessed Niraparib's safety to be a 2 on the scale of 1-3 since it is in Phase 2. This implies that some data supports its security, but there has yet to be any evidence backing up its efficacy."
Answered by AI
Is this the inaugural experiment of its kind?
"Myriad Genetics, Inc. initiated the first clinical trial of Niraparib in 2016 with 733 participants and after successful completion, this medication was approved for Phase 3 trials. Nowadays, 99 active studies involving Niraparib are being conducted across 49 countries and 485 cities."
Answered by AI
Are enrollment opportunities for this investigation presently available?
"Affirmative, the information available on clinicaltrials.gov suggests that this medical trial is still admitting participants. It was originally posted on January 28th 2022 and its latest update occurred in the same month. 20 patients are required from 3 separate sites for this study to be completed successfully."
Answered by AI
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