Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

July 7, 2020

Primary Completion Date

September 29, 2023

Study Completion Date

July 30, 2026

Conditions
GliosarcomaNewly DiagnosedGlioblastoma
Interventions
DRUG

Selinexor

Selinexor will be administered orally at an initial dose of 80 mg. The first dose will be given on day 2 of radiation and will thereafter be administered weekly on the second day of weekly radiation on weeks 1, 2, 4, and 5. If this dose level is tolerated, the dose will be escalated to 60 mg twice a week (days 1 and 4) on weeks 1,2,4,5. The third and final dose level will also be 60mg administered twice weekly for 6 weeks starting on days 1 and 4 radiation.

DRUG

Temozolomide

Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m\^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care.

RADIATION

Generic Radiation therapy (RT)

Radiation therapy (RT) will be administered daily (Monday to Friday)

OTHER

Selective serotonin receptor (5-HT3) antagonists

Anti-emetic for breakthrough nausea.

OTHER

Olanzapine

2.5mg to 5mg once a day if weight loss is rapid.

DIETARY_SUPPLEMENT

Salt tablets

To treat hyponatremia, add salt tablets to participants diet per institutional guidelines.

OTHER

Anti-diarrheal

Treat diarrhea with an anti-diarrheal per institutional guidelines

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH