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PARP Inhibitor
Niraparib for Recurrent Brain Cancer
Phase < 1
Recruiting
Led By Isabel Arrillaga-Romany, MD, Phd
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be on a stable or decreasing dose of glucocorticoids for 7 days prior to registration.
Patient must have Karnofsky Performance Score (KPS) ≥ 70
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is open-label, which means both the research doctor and the participants will know which treatment is being given. This is a phase 0 trial, which means that the purpose of this trial is to learn how the body reacts to the treatment and to find out what the side effects are. This trial will test the effects of Niraparib on subjects with progressive IDH1 or IDH2 mutant, non-enhancing glioma.
Who is the study for?
Adults with confirmed IDH1/2 mutant glioma, evidence of tumor progression, and a Karnofsky Performance Score (KPS) ≥ 70. Must be at least 12 weeks post-CNS radiation, not pregnant or breastfeeding, agree to contraception use, have adequate organ function and no major surgery within the last 4 weeks. Cannot be on other clinical trials or have had certain treatments recently.Check my eligibility
What is being tested?
The trial is testing Niraparib's effects directly in the brain tumors of patients with progressive IDH1/2 mutant gliomas. It's an open-label phase 0 study where participants will undergo resection/treatment to assess how well Niraparib works inside these tumors.See study design
What are the potential side effects?
While specific side effects for Niraparib in this trial are not listed, common ones from similar studies include nausea, fatigue, blood cell count issues (like anemia), digestive problems like constipation or diarrhea, and potential heart risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on a stable or decreasing dose of steroids for at least a week.
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I am mostly able to care for myself and carry out daily activities.
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My tumor can be removed surgically, and I am fit for surgery.
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My kidneys are functioning well enough for treatment.
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My blood counts and organ functions are within the required ranges for the trial.
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My glioma has a confirmed IDH1 or IDH2 mutation.
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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 18 years old or older.
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My brain tumor has grown or come back, confirmed by an MRI.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Drug concentration of niraparib
Secondary outcome measures
D-2-hydroxyglutarate (2-HG) levels by MRS
Duration of Overall Response
Genomic profile
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A Treatment with NiraparibExperimental Treatment2 Interventions
Patients randomized to arm A will receive niraparib daily and undergo tumor resection after 28 days (+/- 7 days) of treatment. The participants in both arms will resume/start on treatment with niraparib 2 -4 weeks after surgery . Participants will continue treatment for up to 12 total cycles of treatment or until tumor progression, unacceptable toxicity or withdrawal of consent
Group II: Arm B No Treatment with NiraparibActive Control1 Intervention
Subjects in arm B will not receive niraparib prior to surgery. The participants in both arms will resume/start on treatment with niraparib 2 -4 weeks after surgery . Participants will continue treatment for up to 12 total cycles of treatment or until tumor progression, unacceptable toxicity or withdrawal of consent.
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?
GlaxoSmithKlineIndustry Sponsor
4,755 Previous Clinical Trials
8,070,800 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,465 Total Patients Enrolled
Isabel Arrillaga-Romany, MD, PhdPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It has been over 12 weeks since I completed radiation therapy to my brain.I have been on a stable or decreasing dose of steroids for at least a week.I am not pregnant, cannot become pregnant, or will avoid pregnancy during the study.I am not pregnant and agree to avoid pregnancy during the study, or I cannot become pregnant.I have had a hysterectomy, both ovaries or my tubes removed, or I'm committed to using two forms of birth control.I have HIV or active hepatitis B or C.I am mostly able to care for myself and carry out daily activities.My organs are functioning well.My tumor can be removed surgically, and I am fit for surgery.My kidneys are functioning well enough for treatment.I do not have cancer spread to the lining of my brain and spinal cord.I do not have any serious health issues that are not under control.My blood counts and organ functions are within the required ranges for the trial.I have a condition that affects my ability to swallow or absorb pills.I have had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.I agree to use or continue using birth control during and for 3 months after the study.I haven't had any cancer other than skin or treated cervical cancer in the last 2 years.My glioma has a confirmed IDH1 or IDH2 mutation.I haven't had significant radiation therapy affecting my bone marrow recently.I haven't had major surgery in the last 4 weeks and have recovered from any surgery effects.I haven't had cancer treatment in the last 28 days, nor lomustine in the last 6 weeks.I haven't had blood transfusions or certain injections to boost blood cells in the last 4 weeks.I agree not to donate blood during and for 3 months after the study.I am over 45 and have not had a period for more than a year.I am 18 years old or older.My brain tumor has grown or come back, confirmed by an MRI.You are likely to live for at least 6 more months.My brain tumor has grown or come back, but it's mostly not showing up as brighter areas on scans.I have recovered from major side effects of my previous cancer treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B No Treatment with Niraparib
- Group 2: Arm A Treatment with 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.
What is the cap on the population size participating in this clinical trial?
"Affirmative. Clinicaltrials.gov indicates that this medical experiment, initially posted on November 1st 2022, is actively looking for participants. The trial requires 16 patients from a single clinical centre to complete the study."
Answered by AI
Is enrollment for this clinical study still open?
"Clinicaltrials.gov reveals that this experimental trial is still actively seeking participants. Originally posted on November 1st 2022, the study was recently updated on October 19th of the same year."
Answered by AI
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