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ACTIVE NOT RECRUITING
NCT04221503
PHASE2

Niraparib/TTFields in GBM

Sponsor: Abramson Cancer Center at Penn Medicine

View on ClinicalTrials.gov

Summary

Evaluating the efficacy and safety of niraparib and Tumor-Treating Fields (TTFields) in recurrent glioblastoma (GBM).

Official title: A Phase II Study Evaluating the Efficacy and Safety of Niraparib and Tumor-Treating Fields in Recurrent Glioblastoma

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2019-12-30

Completion Date

2026-01

Last Updated

2026-01-08

Healthy Volunteers

No

Interventions

DRUG

Niraparib

Niraparib (\[3S\]-3-\[4-{7-(aminocarbonyl)-2H-indazol-2-yl} phenyl\] piperidine \[tosylate monohydrate salt\]) is an orally available, potent, highly selective poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) -1 and -2 inhibitor. The niraparib drug product is provided as 100-mg capsules filled with a dry blend of niraparib tosylate monohydrate, lactose monohydrate, and magnesium stearate in a hard gelatin capsule.

DEVICE

Optune

Optune, which is manufactured by Novocure, is a portable battery or power supply operated device which produces alternating electrical fields, called tumor treatment fields ("TTFields") within the human body. TTFields are applied to the patient by electrically-insulated surface transducer arrays. TTFields disrupt the rapid cell division exhibited by cancer cells.

PROCEDURE

Planned surgical resection

Surgery of supratentorial glioblastoma (GBM).

Locations (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States