Niraparib for Glioblastoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Glioblastoma+2 More
Niraparib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer treatment that uses both a drug and electric fields to treat brain tumors.

Eligible Conditions
  • Glioblastoma
  • GBM

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: When termination of the study or 5 years after removal from protocol therapy, whichever occurs first.

Year 5
Disease control, defined as achievement of either CR, PR, or SD, as defined by modified Response Assessment in Neuro-Oncology (mRANO) criteria.
Duration of disease control.
Number of AEs (Adverse Events)
Objective radiographic response (ORR)
Objective response rate (ORR) associations.
Overall survival (OS)
Overall survival (OS) associations
Progression-free survival (PFS)
Progression-free survival (PFS) associations

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Stage 1 (Cohort 2): Niraparib + Pembrolizumab
57%Nausea
52%Decreased appetite
48%Anaemia
48%Constipation
43%Fatigue
38%Dyspnoea
24%Oedema peripheral
24%Vomiting
24%Stomatitis
24%Platelet count decreased
19%Insomnia
19%Blood alkaline phosphatase increased
19%Arthralgia
19%Pruritus
14%Pneumonia
14%Diarrhoea
14%Cough
14%Pain
14%Chills
14%Upper respiratory tract infection
14%Weight decreased
14%Neutrophil count decreased
14%Dysgeusia
14%Back pain
14%Muscular weakness
10%Depression
10%Erythema
10%Vision blurred
10%Pleural effusion
10%Atrial fibrillation
10%Neuropathy peripheral
10%Haemorrhoids
10%Haemorrhoidal haemorrhage
10%Anxiety
10%Proctalgia
10%Oropharyngeal pain
10%Wheezing
10%Non-cardiac chest pain
10%Productive cough
10%Gait disturbance
10%Chest pain
10%Urinary tract infection
10%Hypophosphataemia
10%Aspartate aminotransferase increased
10%Dehydration
10%Blood creatinine increased
10%Hypokalaemia
10%Lymphocyte count decreased
10%Alanine aminotransferase increased
10%Rash maculo-papular
10%Pain of skin
10%Overdose
10%Hypothyroidism
5%Dysphonia
5%Sinus tachycardia
5%Angina pectoris
5%Neuroendocrine carcinoma of the skin
5%Gastrooesophageal reflux disease
5%Candida infection
5%Sepsis
5%Dizziness
5%Fall
5%Pulmonary embolism
5%Pneumonitis
5%Respiratory failure
5%Cardiac arrest
5%Pericardial effusion
5%Intestinal obstruction
5%Lactic acidosis
5%Diverticulitis
5%Lethargy
5%Headache
5%Cancer pain
5%Toxicity to various agents
5%Abdominal pain
5%Haematochezia
5%Nasal congestion
5%Asthenia
5%Pyrexia
5%Malaise
5%Hypomagnesaemia
5%Hyponatraemia
5%Amylase increased
5%Hepatic enzyme increased
5%Peripheral sensory neuropathy
5%Pain in extremity
5%Hyperhidrosis
5%Tachycardia
5%Contusion
5%Hypotension
5%Lipase increased
5%Syncope
5%Hyperglycaemia
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03308942) in the Stage 1 (Cohort 2): Niraparib + Pembrolizumab ARM group. Side effects include: Nausea with 57%, Decreased appetite with 52%, Anaemia with 48%, Constipation with 48%, Fatigue with 43%.

Trial Design

2 Treatment Groups

Cohort B
1 of 2
Cohort A
1 of 2
Active Control
Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Niraparib · No Placebo Group · Phase 2

Cohort AExperimental Group · 2 Interventions: Niraparib, Optune · Intervention Types: Drug, Device
Cohort BActiveComparator Group · 3 Interventions: Planned surgical resection, Niraparib, Optune · Intervention Types: Procedure, Drug, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
FDA approved
Optune
2016
Completed Phase 1
~90

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: when termination of the study or 5 years after removal from protocol therapy, whichever occurs first.

Who is running the clinical trial?

Tesaro, Inc.Industry Sponsor
55 Previous Clinical Trials
10,353 Total Patients Enrolled
NovoCure Ltd.Industry Sponsor
52 Previous Clinical Trials
4,516 Total Patients Enrolled
26 Trials studying Glioblastoma
2,588 Patients Enrolled for Glioblastoma
University of PennsylvaniaLead Sponsor
1,816 Previous Clinical Trials
41,115,063 Total Patients Enrolled
7 Trials studying Glioblastoma
168 Patients Enrolled for Glioblastoma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have had a relapse of Crohn's disease.
You have a Karnofsky performance status of 60 or higher.
You have a life expectancy of at least 3 months.
Adequate hematologic parameters.
Patients must have measurable contrast-enhancing disease (defined by at least 1cm x 1cm) by magnetic resonance imaging (MRI) imaging within 28 days of starting study treatment.
You have a diagnosis of glioblastoma that is recurrent following radiation therapy

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 21st, 2021

Last Reviewed: October 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.