Your session is about to expire
← Back to Search
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.
Select...
I am 18 years old or older.
Select...
My high-grade brain tumor has come back, confirmed by MRI or surgery.
Select...
I can provide a sample of my tumor for testing, or I have one already.
Select...
My blood pressure is under control, below 140/90 mmHg.
Select...
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%
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%
Dehydration
9%
Blood bilirubin increased
9%
Dry mouth
9%
Anxiety
9%
Back pain
9%
Alanine aminotransferase increased
9%
Cough
9%
Urinary tract infection
9%
Hypertension
9%
Non-cardiac chest pain
4%
Hot flashes
4%
Oral petechia
4%
Sinus pain
4%
Syncope
4%
Leukocytosis
4%
Ascites
4%
Itchy eyes
4%
Hoarseness
4%
Peripheral sensory neuropathy
4%
Sore throat
4%
Edema limbs
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Hypotension
4%
Hyponatremia
4%
Diarrhea
4%
Esophageal ulcer
4%
Head injury
4%
Skin tear
4%
Hypokalemia
4%
Postnasal drip
4%
Hyperkalemia
4%
Bloating
4%
Flu like symptoms
4%
Tremor
4%
Hyperglycemia
4%
Bruising
4%
Hematuria
4%
Depression
4%
Unknown infection
4%
Upper respiratory infection
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
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.
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
4,766 Previous Clinical Trials
8,105,571 Total Patients Enrolled
University of OklahomaLead Sponsor
455 Previous Clinical Trials
95,641 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.
Share this study with friends
Copy Link
Messenger