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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

No Placebo-Only Group

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 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

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%

Insomnia

22%

Dyspnea

22%

Abdominal pain

17%

Headache

17%

Mucositis oral

17%

Platelet count decreased

17%

Creatinine increased

13%

Vomiting

13%

Rash maculo-papular

13%

Aspartate aminotransferase increased

13%

Sinus tachycardia

Urinary tract infection

Cough

Dehydration

Dry mouth

Hypertension

Non-cardiac chest pain

Alanine aminotransferase increased

Anxiety

Blood bilirubin increased

Back pain

Postnasal drip

Hoarseness

Hypotension

Hot flashes

Peripheral sensory neuropathy

Head injury

Hypokalemia

Hyponatremia

Flu like symptoms

Skin tear

Hyperglycemia

Neutrophil count decreased

Tremor

Bruising

Esophageal ulcer

Diarrhea

Depression

Itchy eyes

Oral petechia

Edema limbs

Upper respiratory infection

Hyperkalemia

Leukocytosis

White blood cell decreased

Lung infection

Bloating

Unknown infection

Hematuria

Ascites

Sinus pain

Sore throat

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Cohort A

Cohort B

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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