Niraparib/TTFields in GBM

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 30, 2019

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
GlioblastomaRecurrent GlioblastomaGBM
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).

Trial Locations (1)

19104

Hospital of the University of Pennsylvania, Philadelphia

All Listed Sponsors
collaborator

Tesaro, Inc.

INDUSTRY

collaborator

NovoCure Ltd.

INDUSTRY

lead

University of Pennsylvania

OTHER