BPM31510 in Treating Patients With Recurrent High-Grade Glioma Previously Treated With Bevacizumab
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|ClinicalTrials.gov Identifier: NCT03020602|
Recruitment Status : Recruiting
First Posted : January 13, 2017
Last Update Posted : April 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gliosarcoma Recurrent Glioblastoma Astrocytoma of Brain Glioblastoma||Other: Laboratory Biomarker Analysis Other: Pharmacological Study Drug: Ubidecarenone Injectable Nanosuspension||Phase 1|
- 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.
- To evaluate plasma pharmacokinetics (PK) when BPM31510 plus vitamin K is given to subjects with HGG recurrent on a BEV containing regimen.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of BPM31510 Plus Vitamin K in Subjects With High-Grade Glioma That Has Recurred on a Bevacizumab Containing Regimen|
|Actual Study Start Date :||January 4, 2017|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2021|
Experimental: Treatment (BPM31510)
Patients receive ubidecarenone injectable nanosuspension IV over 72 hours twice weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Ubidecarenone Injectable Nanosuspension
- 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).
- 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.
- Brain tumor metabolism as measured by PET [ Time Frame: Up to 8 weeks ]Standardized uptake value (SUV) of the HGG will be measured. SUV is the standard PET measure.
- Overall survival (OS) [ Time Frame: From the date of BPM31510 initiation to death, assessed for up to 3 years ]Kaplan-Meier survival estimates for OS will be presented for data at the maximum tolerated dose, with a 95% confidence interval using Greenwood's formula at 3.5 months and 7 months.
- PFS assessed by RANO criteria [ Time Frame: Up to 3 years ]
- Response rate assessed by RANO criteria [ Time Frame: Up to 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020602
|Contact: Sophie Bertrandfirstname.lastname@example.org|
|United States, California|
|Stanford University, School of Medicine||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Sophie Bertrand 650-723-4467 email@example.com|
|Principal Investigator: Seema Nagpal|
|Principal Investigator:||Seema Nagpal||Stanford University|