Niraparib + Optune for Glioblastoma

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Pennsylvania

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests niraparib and TTFields in patients with recurrent glioblastoma. The electric fields weaken the cancer cells, and the drug stops them from fixing themselves, leading to cell death. Tumor-Treating Fields (TTFields) is a noninvasive cancer treatment that uses low-intensity alternating electric fields to disrupt cell division and has been FDA-approved for glioblastoma.

Research Team

Eligibility Criteria

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.

Inclusion 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.

Exclusion Criteria

I have a defect in my skull.

I have not used Optune therapy in the last 6 months.

My tumor is located in the lower part of my brain.

Treatment Details

Interventions

• Niraparib (PARP Inhibitor)
• Optune (Device)

Trial Overview 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.

Participant Groups

Group I: Cohort A Experimental Treatment 2 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 B Active Control 3 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.

Niraparib is already approved in Canada for the following indications:

Approved in Canada as Zejula for:

• Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Dr. Joan Lau

University of Pennsylvania

Chief Executive Officer since 2020

PhD in Neuroscience from the University of Cincinnati College of Medicine, MBA from the Wharton School of Business, BS in Bioengineering from the University of Pennsylvania

Dr. Robert Iannone

University of Pennsylvania

Chief Medical Officer since 2019

MD from Yale University, MSCE from the University of Pennsylvania

Tesaro, Inc.

Industry Sponsor

Trials

57

Recruited

10,600+

NovoCure Ltd.

Industry Sponsor

Trials

64

Recruited

6,100+

Ashley Cordova

NovoCure Ltd.

Chief Executive Officer

Bachelor of Science in Material Engineering from Ben-Gurion University of the Negev, Israel

Uri Weinberg

NovoCure Ltd.

Chief Medical Officer since 2020

MD from an unspecified institution