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Niraparib/TTFields in GBM

NCT04221503 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-08

No results posted yet for this study

Summary

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

Conditions

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).

Sponsors & Collaborators

  • Tesaro, Inc.

    collaborator INDUSTRY

  • NovoCure Ltd.

    collaborator INDUSTRY

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-30
Primary Completion
2026-01-31
Completion
2026-01-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04221503 on ClinicalTrials.gov