A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Efficacy will be assessed by subject progression free survival — 6 months and 12 months
Progression free survival will be determined by measuring the proportion of subjects who have met RANO criteria for complete response, partial response , or stable disease at 6 mo and 12 mo following initiation of BPM31510.
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | |
| Stanford University Cancer Center | Palo Alto | California | |
| Sansum Clinic | Santa Barbara | California | |
| Dana Farber Cancer Institute | Boston | Massachusetts | |
| Valley Health | Ridgewood | New Jersey | |
| Mount Sinai Hospital | New York | New York | |
| Texas Oncology | Austin | Texas | |
| UT Health San Antonio Mays Cancer Center | San Antonio | Texas | |
| Virginia Cancer Specialists | Fairfax | Virginia | |
| Inova | Fairfax | Virginia | |
| Virginia Oncology Associates | Norfolk | Virginia |
More BPGbio trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04752813 on ClinicalTrials.gov ↗ ← All trials in the USA