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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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%

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

Anxiety

Alanine aminotransferase increased

Dehydration

Blood bilirubin increased

Urinary tract infection

Dry mouth

Back pain

Cough

Hypertension

Non-cardiac chest pain

Esophageal ulcer

Skin tear

Diarrhea

Flu like symptoms

Leukocytosis

Oral petechia

Sinus pain

Syncope

Bruising

Unknown infection

Ascites

Itchy eyes

Hoarseness

Peripheral sensory neuropathy

Sore throat

Upper respiratory infection

Depression

Edema limbs

Neutrophil count decreased

Lung infection

White blood cell decreased

Hypotension

Hyponatremia

Head injury

Hypokalemia

Hyperkalemia

Postnasal drip

Bloating

Hot flashes

Hyperglycemia

Hematuria

Tremor

100%

80%

60%

40%

20%

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

Radiation therapy

2013

Completed Phase 3

~2850

Niraparib

2018

Completed Phase 4

~1540

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoOTHER

2,506 Previous Clinical Trials

15,238,513 Total Patients Enrolled

21 Trials studying Glioblastoma

4,079 Patients Enrolled for Glioblastoma

GlaxoSmithKlineIndustry Sponsor

4,755 Previous Clinical Trials

8,070,774 Total Patients Enrolled

7 Trials studying Glioblastoma

344 Patients Enrolled for Glioblastoma

Barrow Neurological InstituteOTHER

24 Previous Clinical Trials

7,021 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are involved in this research initiative?

"Affirmative. Clinicaltrials.gov's records demonstrate that this investigation, which was first listed on October 29th 2021, is currently recruiting participants. 42 patients need to be recruited between 2 distinct medical centres."

Answered by AI

Are the methods employed by this clinical trial unique and cutting-edge?

"The research for Niraparib has been conducted since 2016, when a trial sponsored by Myriad Genetics was completed with 733 participants. The drug subsequently attained Phase 3 approval and currently there are 99 ongoing studies taking place in 485 cities across 49 nations."

Answered by AI

Are recruitment efforts for this trial ongoing?

"Affirmative. Clinicaltrials.gov reveals that this investigation, which was first published on October 29th of 2021 is actively recruiting participants. A total of 42 patients will be enrolled between two medical sites."

Answered by AI

What are the stated aims of this research endeavor?

"The main target of this 6-month long trial is to gauge the presence of chromosomal fusion. Additionally, researchers are gauging overall survival estimates, pharmacodynamics via immunohistochemistry and homogenates assays for PAR concentration, as well as adverse events reported up until 24 months."

Answered by AI

Can you elaborate on the other experiments that have evaluated Niraparib?

"Niraparib was first trialled in 2016 by GSK at an Investigational Site. 72 trials have been concluded thus far and there are 99 ongoing studies, with a concentration of these being conducted out of San Francisco, California."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma

Nader Sanai 2021. "Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05076513.

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