A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 22, 2022

Primary Completion Date

August 25, 2026

Study Completion Date

August 26, 2030

Conditions
GlioblastomaGlioblastoma Multiforme
Interventions
DRUG

BPM31510

Subjects will receive a weekly, 96-h infusion of BPM31510 for a duration of 8 weeks.

OTHER

Vitamin K1

Subjects will receive prophylactic Vitamin K1 at a recommended dose of 10 mg subcutaneously prior to the beginning of each week of BPM31510 therapy.

DRUG

Temozolomide (TMZ)

After 2 wk of treatment with BPM31510 (ie, on Day 15), subjects will start concurrent TMZ 75 mg/m2 once daily (qd) × 42 days. Subjects will receive the standard TMZ treatment for up to 12 cycles post BPM31510 treatment.

RADIATION

Radiation

After 2 wk of treatment with BPM31510 (ie, on Day 15), subjects will start concurrent standard RT for 42 days.

Trial Locations (11)

10029

Mount Sinai Hospital, New York

22031

Virginia Cancer Specialists, Fairfax

22037

Inova, Fairfax

23502

Virginia Oncology Associates, Norfolk

78229

UT Health San Antonio Mays Cancer Center, San Antonio

78705

Texas Oncology, Austin

90048

Cedars-Sinai Medical Center, Los Angeles

93105

Sansum Clinic, Santa Barbara

94305

Stanford University Cancer Center, Palo Alto

02215

Dana Farber Cancer Institute, Boston

07450

Valley Health, Ridgewood

All Listed Sponsors
lead

BPGbio

INDUSTRY