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A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)
Sponsor: BPGbio
Summary
This is a single-arm, non-randomized, open-label Phase 2 therapeutic study that will assess the effects of adding BPM31510 onto a conventional treatment framework of RT and concurrent TMZ chemotherapy for subjects with newly diagnosed glioblastoma.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2022-08-22
Completion Date
2030-08-26
Last Updated
2026-01-26
Healthy Volunteers
No
Conditions
Interventions
BPM31510
Subjects will receive a weekly, 96-h infusion of BPM31510 for a duration of 8 weeks.
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.
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
After 2 wk of treatment with BPM31510 (ie, on Day 15), subjects will start concurrent standard RT for 42 days.
Locations (11)
Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford University Cancer Center
Palo Alto, California, United States
Sansum Clinic
Santa Barbara, California, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Valley Health
Ridgewood, New Jersey, United States
Mount Sinai Hospital
New York, New York, United States
Texas Oncology
Austin, Texas, United States
UT Health San Antonio Mays Cancer Center
San Antonio, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Inova
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States