Sarcoma Oncology Research Center | Santa Monica, CA
Berg
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About
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.
Full description
The study will start with a dose-confirmation phase to establish safety of BPM31510 in combination with RT and TMZ. This phase will follow a standard 3+3 dose design with the starting dose of BPM31510 at 110 mg/kg/week (wk), with 1 potential dose de-escalation to 66 mg/kg/wk in the event a DLT is experienced at the 110 mg/kg dose. Toxicity at this dose level will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (CTCAE v5). Subjects will be monitored for DLTs associated with combination therapy for 30 days (d) (± 5 d) after the end of RT (DLT assessment period). Subjects will continue to be monitored for late radiation-related DLTs during follow up, every 8 wk (± 2 wk) during the first 12 months (mo), and then every 12 wk (± 2 wk) for a total of 5 years (y). Safety oversight will be provided by the independent Data and Safety Monitoring Committee (DSMC). The DSMC will review and confirm all DLT data, make recommendations for dose modifications, if necessary, and continue to monitor safety throughout the study. The efficacy phase of the study will begin after the recommended Phase 2 dose (RP2D) has been confirmed.
Enrollment
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Volunteers
Inclusion criteria
Exclusion criteria
No evidence of residual tumor.
History of clinically significant tumor-related cerebral hemorrhage.
Any serious cardiac history as per protocol.
Uncontrolled or severe coagulopathies or a history of clinically significant bleeding within the past 6 months.
Known predisposition for bleeding such as von Willebrand's disease or other such condition(s).
Uncontrolled concurrent illness.
Prior malignancy except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 3 y prior to first dose of study drug.
Receiving any of the following medications:
Known allergy to CoQ10.
Known allergy or adverse reaction to oral, subcutaneous, or IV Vitamin K1.
Pregnant or lactating.
Known to be positive for the human immunodeficiency virus (HIV). Note: HIV testing is not required for eligibility, but if performed previously and was positive, the subject is ineligible.
Primary purpose
Allocation
Interventional model
Masking
50 participants in 1 patient group
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Central trial contact
Vijay Modur, MD, PhD; Arianne Lyng
Data sourced from clinicaltrials.gov
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