Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma

EARLY_PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

October 29, 2021

Primary Completion Date

March 19, 2024

Study Completion Date

September 30, 2025

Conditions
GlioblastomaGlioblastoma MultiformeGliomaGBMGlioma, MalignantGlioblastoma Multiforme of Brain
Interventions
DRUG

Niraparib

"In Phase 0, 300mg administered orally QD for 4 days prior to resection.~In the Expansion cohort/Maintenance phase, niraparib will be administered as described below:~* For patients weighing \<77 kg (\<170 lbs) OR with a platelet count \<150,000/mcL, the recommended dosage is 200 mg taken orally once daily.~* For patients weighing ≥77 kg (≥170 lbs) AND a platelet count ≥150,000/ mcL, the recommended dosage is 300 mg taken orally once daily."

RADIATION

Radiation therapy

Participants in Arm A who move onto the Expansion cohort will receive 6-7 weeks of radiation therapy per standard of care.

Trial Locations (1)

85013

St. Joseph's Hospital and Medical Center, Phoenix

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Barrow Neurological Institute

OTHER

collaborator

Ivy Brain Tumor Center

OTHER

collaborator

University of California, San Francisco

OTHER

collaborator

GlaxoSmithKline

INDUSTRY

lead

Nader Sanai

OTHER