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PARP Inhibitor
Niraparib + Optune for Glioblastoma
Phase 2
Waitlist Available
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be able to swallow oral medications
Karnofsky performance status >= 60
Timeline
Screening 3 weeks
Treatment Varies
Follow Up when termination of the study or 5 years after removal from protocol therapy, whichever occurs first.
Awards & highlights
Study Summary
This trial is testing a new cancer treatment that uses both a drug and electric fields to treat brain tumors.
Who is the study for?
This trial is for adults over 22 with recurrent glioblastoma after radiation therapy. They must understand and consent to the study, have measurable disease by MRI, be in stable health with a life expectancy over 3 months, and agree to contraception. Excluded are those with certain blood disorders, prior Optune use within 6 months, hypersensitivity to treatment components or severe medical conditions.Check my eligibility
What is being tested?
The trial tests niraparib's effectiveness combined with Tumor-Treating Fields (TTFields) on recurrent glioblastoma. It includes patients who've had multiple relapses and measures safety alongside efficacy of this combination therapy.See study design
What are the potential side effects?
Potential side effects include blood-related issues like anemia or thrombocytopenia from niraparib; skin irritation or discomfort from TTFields device; as well as general drug-related reactions such as fatigue, nausea, or allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow pills.
Select...
I can care for myself but may need occasional help.
Select...
My brain tumor's MGMT methylation status is known from a previous test.
Select...
My glioblastoma has returned after radiation treatment.
Select...
My kidney function is good as tested within the last week.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ when termination of the study or 5 years after removal from protocol therapy, whichever occurs first.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~when termination of the study or 5 years after removal from protocol therapy, whichever occurs first.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease control, defined as achievement of either CR, PR, or SD, as defined by modified Response Assessment in Neuro-Oncology (mRANO) criteria.
Secondary outcome measures
Duration of disease control.
Number of AEs (Adverse Events)
Objective radiographic response (ORR)
+2 moreOther outcome measures
Objective response rate (ORR) associations.
Overall survival (OS) associations
Progression-free survival (PFS) associations
Side effects data
From 2022 Phase 2 trial • 37 Patients • NCT0320734774%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Anemia
30%
Alkaline phosphatase increased
26%
Weight loss
22%
Dyspnea
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Platelet count decreased
17%
Mucositis oral
17%
Creatinine increased
13%
Sinus tachycardia
13%
Vomiting
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Dehydration
9%
Blood bilirubin increased
9%
Urinary tract infection
9%
Dry mouth
9%
Back pain
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Esophageal ulcer
4%
Skin tear
4%
Diarrhea
4%
Edema limbs
4%
Leukocytosis
4%
Syncope
4%
Head injury
4%
Oral petechia
4%
Sinus pain
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Itchy eyes
4%
Flu like symptoms
4%
Hoarseness
4%
Peripheral sensory neuropathy
4%
Sore throat
4%
Upper respiratory infection
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Hypotension
4%
Hyponatremia
4%
Hypokalemia
4%
Depression
4%
Postnasal drip
4%
Hyperkalemia
4%
Bloating
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cohort AExperimental Treatment2 Interventions
Cohort A is for subjects with recurrent glioblastoma who do not have clinical indication for surgical resection of the recurrent tumor. Subjects in Cohort A will initiate and continue TTFields therapy for 5-7 days prior to starting niraparib.
Group II: Cohort BActive Control3 Interventions
Cohort B is for subjects with recurrent glioblastoma who have a clinical indication for surgical resection of the recurrent tumor. Subjects in Cohort B will receive TTFields for 5-7 days prior to planned surgical resection, undergo surgical resection, resume TTFields postoperatively, and initiate niraparib 5- 7 days after starting TTFields postoperatively.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Optune
2016
Completed Phase 1
~90
Niraparib
FDA approved
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,058 Total Patients Enrolled
7 Trials studying Glioblastoma
175 Patients Enrolled for Glioblastoma
Tesaro, Inc.Industry Sponsor
56 Previous Clinical Trials
10,526 Total Patients Enrolled
NovoCure Ltd.Industry Sponsor
57 Previous Clinical Trials
4,692 Total Patients Enrolled
28 Trials studying Glioblastoma
2,714 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood test results are within normal ranges.I am in Cohort B and my doctor has determined I need surgery.I have a form showing I can provide tissue from my past brain tumor surgery.I have a defect in my skull.I have recovered from serious side effects of my previous treatments.I have not used Optune therapy in the last 6 months.I understand the study and agree to participate, or I have someone who can consent for me if I'm unable.My liver is functioning well, as tested within the last week.My tumor is located in the lower part of my brain.I have had treatments for multiple relapses of my condition.I have had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.I agree not to donate blood during the study or for 90 days after my last dose.I do not have any serious health issues that are not under control.I am allergic to certain gel materials or ingredients in niraparib.You are expected to live for at least 3 more months.I can swallow pills.I can care for myself but may need occasional help.My brain tumor's MGMT methylation status is known from a previous test.I am younger than 22 years old.I have or had myelodysplastic syndrome or acute myeloid leukemia.I do not have stomach or intestine problems affecting medicine absorption.My glioblastoma has returned after radiation treatment.My kidney function is good as tested within the last week.My MRI shows a tumor that is at least 1cm big.I have been treated with a PARP inhibitor before.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A
- Group 2: Cohort B
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the U.S. Food and Drug Administration sanctioned Niraparib for medical use?
"This Phase 2 trial has gathered some evidence supporting the security of Niraparib, warranting it a score of two on our team's safety scale."
Answered by AI
Is this experiment the initial instance of its kind?
"Presently, there are 99 active studies for Niraparib spanning over 49 nations and 485 cities. The first clinical trial began in 2016 and was sponsored by Myriad Genetics Incorporated; it involved 733 participants who completed the Phase 3 drug approval process. Since then, 19 other trials have concluded their investigations successfully."
Answered by AI
What is the current cap for enrolment in this clinical experiment?
"Affirmative. Clinicaltrials.gov reveals that this medical examination, which was initially published on December 30th 2019, is actively looking for volunteers. Approximately thirty patients must be enroll from a single site."
Answered by AI
Are there still enrollments available for the clinical trial?
"Yes, this medical trial is currently recruiting candidates. According to the clinicaltrials.gov record, it was initially posted on December 30th 2019 and last revised on August 29th 2022."
Answered by AI
Are there any documented precedents of Niraparib being examined in a research project?
"Currently, there are 99 active studies looking into Niraparib. 13 of these clinical trials have entered Phase 3 and 2817 locations in Washington D.C., alone, are running Niraparib related experiments."
Answered by AI
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