Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
10

Summary

Conditions
  • Astrocytoma of Brain
  • Glioblastoma
  • Gliosarcoma
  • Recurrent Glioblastoma
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Primary Objective: Assess the safety and tolerability of BPM31510 plus vitamin K in subjects with high-grade glioma(HGG), defined as anaplastic astrocytoma (AA) or glioblastoma (GB) that has recurred on a BEV containing regimen. Secondary Objectives: To evaluate plasma pharmacokinetics (PK) when BPM...

Primary Objective: Assess the safety and tolerability of BPM31510 plus vitamin K in subjects with high-grade glioma(HGG), defined as anaplastic astrocytoma (AA) or glioblastoma (GB) that has recurred on a BEV containing regimen. Secondary Objectives: To evaluate plasma pharmacokinetics (PK) when BPM31510 plus vitamin K is given to subjects with HGG recurrent on a BEV containing regimen. Exploratory Objectives: Estimate the overall survival in subjects with HGG recurrent on a BEV containing regimen from the 1st day of infusion of BPM31510 plus vitamin K to death. To evaluate the effects of BPM31510 plus vitamin K on shifting HGG metabolism to aerobic respiration by PET imaging. To evaluate the effects of BPM1510 plus vitamin K on MRI imaging by Response Assessment in Neuro Oncology (RANO) criteria [specifically progression free survival (PFS) and response rate (RR)]. To evaluate plasma pharmacodynamics (PD) when BPM31510 plus vitamin K is given to subjects with HGG recurrent on a BEV containing regimen.

Tracking Information

NCT #
NCT03020602
Collaborators
Not Provided
Investigators
Principal Investigator: Seema Nagpal Stanford University
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