Clinical Trial: BPM31510 in Treating Patients With Recurrent Glioblastoma or Gliosarcoma Previously Treated With Bevacizumab

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase I Study of BPM31510 Plus Vitamin K in Subjects With Glioblastoma That Has Recurred on a Bevacizumab-Containing Regimen

Brief Summary: This phase I trial studies the side effects and best dose of ubidecarenone injectable nanosuspension (BPM31510) in treating patients with glioblastoma or gliosarcoma that has come back and have been previously treated with bevacizumab. BPM31510 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Summary:

PRIMARY OBJECTIVES:

I. Assess the safety and tolerability of BPM31510 plus vitamin K in subjects with glioblastoma (GB) that has recurred on a bevacizumab (BEV)-containing regimen.

SECONDARY OBJECTIVES:

I. To evaluate plasma pharmacokinetics (PK) when BPM31510 plus vitamin K is given to subjects with GB recurrent on a BEV-containing regimen.

TERTIARY OBJECTIVES:

I. Estimate the overall survival in subjects with GB recurrent on a BEV-containing regimen from the 1st day of infusion of BPM31510 plus vitamin K to death.

II. To evaluate the effects of BPM31510 plus vitamin K on shifting GB metabolism to aerobic respiration by positron emission tomography (PET) imaging.

III. To evaluate the effects of BPM1510 plus vitamin K on magnetic resonance imaging (MRI) imaging by Response Assessment in Neuro-Oncology (RANO) criteria (specifically progression-free survival [PFS] and response rate [RR]).

IV. To evaluate plasma pharmacodynamics (PD) when BPM31510 plus vitamin K is given to subjects with GB recurrent on a BEV-containing regimen.

OUTLINE: This is a dose-escalation study.

Patients receive ubidecarenone injectable nanosuspension intravenously (IV) over 72 hours twice weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 12 weeks.


Sponsor: Seema Nagpal

Current Primary Outcome: Percentage of patients with dose-limiting toxicities defined as thrombocytopenia >= grade 3, hemorrhage >= grade 3, and INR elevation >= grade 2 assessed by CTCAE v4.03 [ Time Frame: Up to 28 days ]

Will be tabulated at each dose, along with the result of the pooled adjacent violators algorithm as implemented in the Modified Toxicity Probability Interval (equal weights, and the weighted mean solver).


Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of adverse events graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version (v)4.03 [ Time Frame: Up to 30 days after last dose of BPM3150 ]

Will be tabulated separately for each dose cohort, by Medical Dictionary for Regulatory Activities (MedDRA) major organ system and severity.


Original Secondary Outcome: Same as current

Information By: Stanford University

Dates:
Date Received: January 5, 2017
Date Started: January 2017
Date Completion: January 2021
Last Updated: January 11, 2017
Last Verified: January 2017