A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

June 8, 2020

Primary Completion Date

July 3, 2023

Study Completion Date

July 3, 2023

Conditions
Glioblastoma Multiforme
Interventions
DRUG

Selinexor

Dose and Formulation: 20 milligram (mg); Tablet Route of Administration: Oral

DRUG

Temozolomide (TMZ)

Dose strength and Formulation: 5, 20, 100, 140, 180, or 250 mg; Capsule Route of Administration: Oral

DRUG

Lomustine (CCNU)

Dose and Formulation: 10, 40, or 100 mg; Capsule Route of Administration: Oral

RADIATION

Standard Fractionated Radiation therapy (RT)

Radiation Therapy Oncology Group (RTOG) or European Organisation for Research and Treatment of Cancer (EORTC) methodologies of approximately 60 Gy in 30 fractions.

DRUG

Bevacizumab

Dose and Formulation: 10 mg/kg; Route of Administration: Intravenous

DEVICE

TTField

Dose and Formulation: 200 kHz ≥18h/day; Route of administration: Scalp application of transducer arrays.

DRUG

Carmustine

Dose and Formulation: 150 or 200 mg/m\^2; Route of Administration: Intravenous

Trial Locations (18)

10032

Columbia University Irving Medical Center, New York

10075

Lenox Hill Hospital-Northwell Health, New York

11042

Northwell Health, Lake Success

30309

Piedmont Healthcare, Atlanta

33176

Baptist Hospital of Miami Cancer Institute, 8900 North Kendall Drive, Miami

35294

University of Alabama, Birmingham

44195

Cleveland Clinic, Cleveland

60611

Northwestern University Feinberg School of Medicine, Chicago

77030

MD Anderson Cancer Center, Houston

84112

University of Utah - Huntsman Cancer Institute, Salt Lake City

90033

University of Southern California (USC Norris Comprehensive Cancer Center and LAC+USC Medical Center), Los Angeles

94122

University of California, San Francisco

98109

University of Washington - Alvord Brain Tumor Center, Seattle

02114

Massachusetts General Hospital, Boston

02215

Dana Farber Cancer Institute, Boston

07601

Hackensack Meridian Health, 92 Second Street, Hackensack

07960

Atlantic Health Systems Hospital Corp., Morristown

M5G 2MG

Princess Margaret Hospital (PMH), Toronto

Sponsors
All Listed Sponsors
lead

Karyopharm Therapeutics Inc

INDUSTRY