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ACTIVE NOT RECRUITING
NCT04752813
PHASE2

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

Sponsor: BPGbio

View on ClinicalTrials.gov

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

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.

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