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PARP Inhibitor

Niraparib vs Temozolomide for Brain Cancer

Phase 3
Recruiting
Research Sponsored by Ivy Brain Tumor Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Histologic documentation of a newly-diagnosed intracranial GBM, per 2021 WHO classification guidelines through local pathology review.
6. No prior treatment for GBM (including brachytherapy or BCNU wafers), other than surgical resection or biopsy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Summary

"This trial will compare two drugs, niraparib and temozolomide, to see which one is more effective for treating a specific type of brain cancer called glioblastoma. The

Who is the study for?
This trial is for adults over 18 with a new diagnosis of glioblastoma multiforme (GBM) that hasn't been treated yet, except for surgery. Participants need to be in good physical condition and not planning pregnancy or breastfeeding. They must agree to use effective contraception.
What is being tested?
The study compares the effectiveness of niraparib against temozolomide (TMZ), which is standard treatment for GBM without MGMT methylation. It will assess if niraparib can extend the time before cancer worsens or improve overall survival compared to TMZ.
What are the potential side effects?
Potential side effects from niraparib and temozolomide include nausea, fatigue, blood cell count changes leading to increased infection risk, liver function changes, and other common chemotherapy-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My diagnosis is a new brain tumor identified as GBM.
Select...
I have not had any treatment for GBM except for surgery or biopsy.
Select...
I am mostly able to care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall survival
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR)
Secondary study objectives
Changes from baseline in neurocognitive function assessed by Controlled Oral Word Association
Changes from baseline in neurocognitive function assessed by Hopkins Verbal Learning Test
Changes from baseline in neurocognitive function assessed by Trail Making Test Parts A and B
+6 more

Side effects data

From 2022 Phase 2 trial • 37 Patients • NCT03207347
74%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Anemia
30%
Alkaline phosphatase increased
26%
Weight loss
22%
Dizziness
22%
Dyspnea
22%
Insomnia
22%
Abdominal pain
17%
Headache
17%
Mucositis oral
17%
Platelet count decreased
17%
Creatinine increased
13%
Vomiting
13%
Aspartate aminotransferase increased
13%
Rash maculo-papular
13%
Sinus tachycardia
9%
Urinary tract infection
9%
Hypertension
9%
Dry mouth
9%
Cough
9%
Dehydration
9%
Non-cardiac chest pain
9%
Alanine aminotransferase increased
9%
Anxiety
9%
Blood bilirubin increased
9%
Back pain
4%
White blood cell decreased
4%
Head injury
4%
Hyperglycemia
4%
Hypokalemia
4%
Hyponatremia
4%
Depression
4%
Esophageal ulcer
4%
Flu like symptoms
4%
Bruising
4%
Leukocytosis
4%
Skin tear
4%
Oral petechia
4%
Hypotension
4%
Tremor
4%
Diarrhea
4%
Itchy eyes
4%
Postnasal drip
4%
Edema limbs
4%
Upper respiratory infection
4%
Hoarseness
4%
Hot flashes
4%
Hyperkalemia
4%
Neutrophil count decreased
4%
Peripheral sensory neuropathy
4%
Lung infection
4%
Bloating
4%
Unknown infection
4%
Hematuria
4%
Ascites
4%
Sinus pain
4%
Sore throat
4%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: NiraparibExperimental Treatment1 Intervention
Group II: Arm B: TemozolomideActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~2400

Find a Location

Who is running the clinical trial?

Ivy Brain Tumor CenterLead Sponsor
11 Previous Clinical Trials
389 Total Patients Enrolled
8 Trials studying Glioblastoma
253 Patients Enrolled for Glioblastoma
GlaxoSmithKlineIndustry Sponsor
4,788 Previous Clinical Trials
8,176,357 Total Patients Enrolled
8 Trials studying Glioblastoma
386 Patients Enrolled for Glioblastoma
Nader Sanai, MDStudy ChairIvy Brain Tumor Center
13 Previous Clinical Trials
569 Total Patients Enrolled
8 Trials studying Glioblastoma
246 Patients Enrolled for Glioblastoma
~300 spots leftby Dec 2027
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