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PARP Inhibitor
Niraparib for Brain Cancer (OU-SCC-PI-4G Trial)
Phase 2
Waitlist Available
Led By James Battiste, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be able to take oral medications
Patients must be ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
OU-SCC-PI-4G Trial Summary
This trial is testing a new drug, niraparib, to see if it can help treat patients with recurrent brain cancer.
Who is the study for?
Adults with recurrent high-grade gliomas (GBM, Astrocytoma, Oligodendroglioma) who can take oral meds and have a life expectancy of at least 3 months. They must be stable on corticosteroids if used, not pregnant or breastfeeding, willing to use contraception, and not donate blood during the study. Excludes those with other recent cancers except certain skin cancers, prior PARP inhibitor treatment, active hepatitis B/C or HIV with detectable viral load.Check my eligibility
What is being tested?
The trial is testing niraparib's effects on patients with recurrent brain cancer. It aims to understand both positive outcomes and adverse reactions from taking this medication in individuals whose previous treatments for brain tumors have failed.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with niraparib include nausea, fatigue, blood cell count issues which could lead to anemia or infection risks; heart palpitations; constipation; muscle and joint pain.
OU-SCC-PI-4G Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take pills by mouth.
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I am 18 years old or older.
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My high-grade brain tumor has come back, confirmed by MRI or surgery.
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I can provide a sample of my tumor for testing, or I have one already.
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My blood pressure is under control, below 140/90 mmHg.
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I can take care of myself and am up and about more than half of my waking hours.
OU-SCC-PI-4G Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of treatment in Dose expansion phase
Number of patients who experience toxicities with individualized starting dose (ISD) of niraparib using CTCAE v5.0 [Safety of niraparib] in dose expansion phase
Number of patients who experience toxicities with individualized starting dose (ISD) of niraparib using CTCAE v5.0. [Safety and Tolerability of niraparib] in safety-lead in phase
Secondary outcome measures
Duration of disease control of all patients
Overall survival in Dose expansion phase
Progression free survival in Dose expansion phase
Side 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%
Dyspnea
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Platelet count decreased
17%
Mucositis oral
17%
Creatinine increased
13%
Sinus tachycardia
13%
Vomiting
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Urinary tract infection
9%
Dehydration
9%
Back pain
9%
Blood bilirubin increased
9%
Dry mouth
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Esophageal ulcer
4%
Skin tear
4%
Diarrhea
4%
Edema limbs
4%
Leukocytosis
4%
Syncope
4%
Hypotension
4%
Head injury
4%
Oral petechia
4%
Sinus pain
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Itchy eyes
4%
Flu like symptoms
4%
Hoarseness
4%
Peripheral sensory neuropathy
4%
Sore throat
4%
Upper respiratory infection
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Depression
4%
Hyponatremia
4%
Hypokalemia
4%
Postnasal drip
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
OU-SCC-PI-4G Trial Design
1Treatment groups
Experimental Treatment
Group I: Niraparib TreatmentExperimental Treatment1 Intervention
Patients will be treated with individualized starting dose of Niraparib.
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
4,750 Previous Clinical Trials
8,067,437 Total Patients Enrolled
University of OklahomaLead Sponsor
455 Previous Clinical Trials
97,595 Total Patients Enrolled
James Battiste, MDPrincipal InvestigatorStephenson Cancer Center
1 Previous Clinical Trials
27 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take pills by mouth.I have HIV with controlled viral load and CD4 count ≥ 350.I have an active hepatitis B or C infection.I haven't had blood transfusions or certain medications in the last 4 weeks.I haven't had cancer treatment in the last 4 weeks.I have a serious health condition that is not under control.I have a history of MDS or AML.I haven't had significant radiation therapy affecting my bone marrow recently.I am 18 years old or older.My organs are functioning well.My high-grade brain tumor has come back, confirmed by MRI or surgery.I haven't been in a clinical trial for a new drug or device within the last 4 weeks or 5 half-lives of the drug.I have been treated with a PARP inhibitor before.I can provide a sample of my tumor for testing, or I have one already.I have serious stomach or bowel issues that affect how my body absorbs medicine.I am a woman who can have children, have a recent negative pregnancy test, and agree to avoid pregnancy during the study.I agree to use contraception or practice abstinence during and up to 180 days after my treatment.I am not allergic to niraparib or its ingredients like lactose monohydrate and magnesium stearate.My blood pressure is under control, below 140/90 mmHg.I haven't had major surgery in the last 4 weeks and have recovered from any surgeries I've had.I haven't needed treatment for another cancer, except for certain skin cancers or cervical cancer, in the last 3 years.I can take care of myself and am up and about more than half of my waking hours.I have been on a stable dose of corticosteroids for at least 4 weeks.I have had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Niraparib Treatment
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 opportunities available to join this experiment right now?
"According to clinicaltrials.gov, this medical trial is actively in search of participants. The experiment was first advertised on June 9th 2022 and its information has been amended most recently on July 20th 2022."
Answered by AI
Has the FDA sanctioned Niraparib for public use?
"Niraparib's safety is assessed to be a 2 on our 1-3 scale, as this Phase2 trial has established some evidence of safety but not efficacy."
Answered by AI
What is the anticipated participant count for this research endeavor?
"Indeed, clinicaltrials.gov reveals that this medical investigation is presently recruiting individuals. This trial was originally presented on the 9th of June 2022 and recently modified on 20th July 2022. 45 patients must be sourced from a single site for completion of this study."
Answered by AI
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