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PARP Inhibitor

Niraparib + Radiation for Brain Tumor

Phase < 1
Recruiting
Led By Nader Sanai, MD
Research Sponsored by Nader Sanai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant who is no longer of childbearing potential due to surgical, chemical, or natural menopause. If the serum pregnancy test is completed > 7 days from Day 1, a urine pregnancy test will be done to confirm a negative result prior to Day 1 dose administration
Arm A participants undergoing resection for a suspected newly diagnosed glioblastoma
Must not have
Participant has myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML
Active infection or fever >38.5°C requiring systemic antibiotic, antifungal or antiviral therapy within 4 weeks of Day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights

Summary

This trial will enroll up to 24 participants with newly-diagnosed glioblastoma and up to 18 recurrent glioma participants with IDH mutation and ATRX loss. The trial will be composed of a Phase 0 component (subdivided into Arm A and B) and a therapeutic expansion phase. Patients with tumors demonstrating a positive PK Response (in Arm A) or a positive PD Response (in Arm B) of the Phase 0 component of the study will graduate to a therapeutic expansion phase that combines therapeutic dosing of niraparib plus standard-of-care fractionated radiotherapy (in Arm A) or nir

Who is the study for?
Adults over 18 with newly-diagnosed glioblastoma or recurrent glioma with specific genetic mutations can join. They must have recovered from any previous chemotherapy, have normal blood pressure, adequate organ function, and not be pregnant or breastfeeding. Participants need to agree to use effective contraception and adhere to lifestyle considerations for the study duration.
What is being tested?
The trial is testing Niraparib in combination with standard radiotherapy for some patients (Arm A), and as a single therapy for others (Arm B). It's an open-label Phase 0 study followed by an expansion phase based on initial responses, aiming to enroll up to 42 participants across multiple centers.
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of Niraparib may include nausea, fatigue, blood cell count changes leading to increased infection risk or bruising/bleeding tendencies, heart palpitations, insomnia, headache and hypertension.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant or cannot become pregnant due to surgery, menopause, or other reasons.
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I am having surgery for a suspected new glioblastoma diagnosis.
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I am mostly able to care for myself and perform daily activities.
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I can swallow pills.
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My blood tests show my organs and bone marrow are working well.
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I have a tumor that can be measured and is at least 1 cm in size.
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I have recovered from chemotherapy side effects, except for possible hair loss or mild nerve pain.
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My blood pressure is normal or well-controlled with treatment.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.
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I haven't needed antibiotics or antivirals for an infection or high fever in the last 4 weeks.
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I do not have an active infection needing IV antibiotics or a known virus like HIV or hepatitis B/C.
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I have been treated with PARP inhibitors at a dose meant to treat my condition.
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I meet the heart health requirements.
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I do not have severe infections or serious liver diseases.
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I am currently using a blood thinner that cannot be stopped before surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 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
Phase 0 Arm A: Total and unbound niraparib concentration in enhancing and nonenhancing tissue
Phase 0 Arm B: Presence of Chromosomal fusion
Phase 0 Expansion Arm A: Progression-free survival in participants with demonstrated PK effects
+1 more
Secondary study objectives
Adverse events
Deaths
Drug-related toxicity
+4 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
Group I: Arm B: Recurrent Glioma (Grades II-IV)Experimental Treatment1 Intervention
Participants undergoing resection of a recurrent WHO Grade II, III, or IV glioma with IDH1 or IDH2 mutation and ATRX loss will be treated with niraparib for 4 days prior to a planned surgical resection. Participants who proceed to the Expansion cohort will receive niraparib in 28d cycles after surgery.
Group II: Arm A: Presumed Newly-Diagnosed glioblastomaExperimental Treatment2 Interventions
Participants undergoing resection for a presumed newly-diagnosed glioblastoma (WHO grade 4) will be treated with niraparib for 4 days prior to surgical resection. Participants who proceed to the therapeutic expansion phase of this study will receive niraparib in combination with radiation (60 Gy over 6-7 weeks, as per standard of care). Following radiotherapy, eligible study participants may receive niraparib maintenance treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~2400
Radiation therapy
2013
Completed Phase 3
~2850

Find a Location

Who is running the clinical trial?

University of California, San FranciscoOTHER
2,551 Previous Clinical Trials
15,257,844 Total Patients Enrolled
21 Trials studying Glioblastoma
4,103 Patients Enrolled for Glioblastoma
GlaxoSmithKlineIndustry Sponsor
4,788 Previous Clinical Trials
8,176,765 Total Patients Enrolled
8 Trials studying Glioblastoma
794 Patients Enrolled for Glioblastoma
Barrow Neurological InstituteOTHER
25 Previous Clinical Trials
6,983 Total Patients Enrolled
7 Trials studying Glioblastoma
211 Patients Enrolled for Glioblastoma

Media Library

Niraparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05076513 — Phase < 1
Glioblastoma Research Study Groups: Arm B: Recurrent Glioma (Grades II-IV), Arm A: Presumed Newly-Diagnosed glioblastoma
Glioblastoma Clinical Trial 2023: Niraparib Highlights & Side Effects. Trial Name: NCT05076513 — Phase < 1
Niraparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05076513 — Phase < 1
~11 spots leftby Sep 2025
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