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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
Must not have
Known active hepatitis B or hepatitis C
Patients have medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active hepatitis B or C infection.
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I have a serious health condition that is not under control.
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I have a history of MDS or AML.
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I haven't had significant radiation therapy affecting my bone marrow recently.
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I have been treated with a PARP inhibitor before.
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I have serious stomach or bowel issues that affect how my body absorbs medicine.
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I am not allergic to niraparib or its ingredients like lactose monohydrate and magnesium stearate.
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I have had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

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 • NCT03207347
74%
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%
Vomiting
13%
Sinus tachycardia
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
9%
Back pain
9%
Alanine aminotransferase increased
9%
Blood bilirubin increased
9%
Non-cardiac chest pain
9%
Anxiety
9%
Dry mouth
9%
Cough
9%
Urinary tract infection
9%
Hypertension
9%
Dehydration
4%
Hyperkalemia
4%
Head injury
4%
Bloating
4%
Unknown infection
4%
Hyponatremia
4%
Syncope
4%
Ascites
4%
Hoarseness
4%
Upper respiratory infection
4%
Lung infection
4%
Tremor
4%
White blood cell decreased
4%
Hypotension
4%
Sinus pain
4%
Diarrhea
4%
Esophageal ulcer
4%
Hypokalemia
4%
Skin tear
4%
Sore throat
4%
Leukocytosis
4%
Flu like symptoms
4%
Neutrophil count decreased
4%
Peripheral sensory neuropathy
4%
Bruising
4%
Postnasal drip
4%
Hematuria
4%
Depression
4%
Edema limbs
4%
Hot flashes
4%
Oral petechia
4%
Hyperglycemia
4%
Itchy eyes
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for brain tumors include surgery, radiotherapy, chemotherapy, and targeted therapies. Surgery aims to remove as much of the tumor as possible, reducing mass effect and symptoms. Radiotherapy uses high-energy radiation to kill cancer cells and shrink tumors. Chemotherapy, such as temozolomide, disrupts cancer cell division and growth. Targeted therapies, like PARP inhibitors (e.g., niraparib), block specific enzymes involved in DNA repair, making cancer cells more susceptible to damage and death. These treatments are crucial for brain tumor patients as they can improve survival rates and quality of life by targeting the tumor more effectively and reducing recurrence.
Combining PARP inhibitors with radiation therapy for the treatment of glioblastoma: Is PTEN predictive of response?Advances in the biology of astrocytomas.

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineIndustry Sponsor
4,772 Previous Clinical Trials
8,106,888 Total Patients Enrolled
University of OklahomaLead Sponsor
457 Previous Clinical Trials
95,740 Total Patients Enrolled
James Battiste, MDPrincipal InvestigatorStephenson Cancer Center
1 Previous Clinical Trials
27 Total Patients Enrolled

Media Library

Niraparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05297864 — Phase 2
Brain Tumor Research Study Groups: Niraparib Treatment
Brain Tumor Clinical Trial 2023: Niraparib Highlights & Side Effects. Trial Name: NCT05297864 — Phase 2
Niraparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05297864 — Phase 2
~5 spots leftby Jul 2025