Back to resultsA Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)
Primary Purpose
Glioblastoma, Glioblastoma Multiforme
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BPM31510
Vitamin K1
Temozolomide (TMZ)
Radiation
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma
Eligibility Criteria
Inclusion Criteria:
- Subjects with newly diagnosed pathologically verified GB.
- No prior RT, chemotherapy, immunotherapy, or targeted agents administered specifically for the lesion being treated.
- Age ≥18 y.
- Life expectancy ≥3 months.
- Karnofsky performance score ≥60.
- Adequate organ and marrow function as per protocol.
- Ability for subject to understand and the willingness to sign a written ICF.
- Subjects of childbearing potential must agree to use hormonal or barrier birth control with spermicidal gel to avoid pregnancy during the study.
- Be at least 14 d out from surgery.
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:
- Therapeutic doses of any anticoagulant, including low-molecular weight heparin. Concomitant use of warfarin, even at prophylactic doses, is prohibited.
- Digoxin, digitoxin, lanatoside C, or any type of digitalis alkaloids.
- Antiangiogenic drugs (ie, Avastin) either in the past 2 wk or if anticipated within the next 2 wk of informed consent.
- Theophylline
- 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.
Sites / Locations
- Cedars-Sinai Medical CenterRecruiting
- Stanford University Cancer CenterRecruiting
- Sarcoma Oncology Research Center
- Mount Sinai Hospital
- Inova
- University of Washington
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BPM31510, Vitamin K1, RT and TMZ
Arm Description
Subjects will receive a BPM31510 96hr infusion once weekly for 8 wk. Prophylactic Vitamin K1 at a recommended dose of 10 mg will be given intramuscular (IM) to all subjects prior to the beginning of each week of therapy. After 2 wk of treatment with BPM31510, subjects will start concurrent standard RT and TMZ 75 mg/m2 once daily (qd) × 42 days. Subjects will receive the standard TMZ treatment for additional 6 cycles post BPM31510 treatment.
Outcomes
Primary Outcome Measures
Efficacy will be assessed by subject progression free survival
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 following initiation of BPM31510.
Secondary Outcome Measures
Efficacy will be assessed by subject Overall survival
Overall survival as determined by measuring from start date of BPM31510 to the date of death or date of last follow-up (for subjects who have not died).
Safety and tolerability of BPM31510 and Vitamin K1 will be assessed by incidence of dose limiting toxicities (DLTs) and adverse events (AEs).
A DLT is defined as an event possibly related to BPM31510 and clearly not due to an underlying disease or extraneous causes. An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Full Information
NCT ID
NCT04752813
First Posted
February 1, 2021
Last Updated
June 3, 2023
Sponsor
Berg, LLC
Collaborators
BPGbio
1. Study Identification
Unique Protocol Identification Number
NCT04752813
Brief Title
A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)
Official Title
A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2023 (Anticipated)
Primary Completion Date
December 24, 2025 (Anticipated)
Study Completion Date
May 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Berg, LLC
Collaborators
BPGbio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Glioblastoma Multiforme
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BPM31510, Vitamin K1, RT and TMZ
Arm Type
Experimental
Arm Description
Subjects will receive a BPM31510 96hr infusion once weekly for 8 wk. Prophylactic Vitamin K1 at a recommended dose of 10 mg will be given intramuscular (IM) to all subjects prior to the beginning of each week of therapy.
After 2 wk of treatment with BPM31510, subjects will start concurrent standard RT and TMZ 75 mg/m2 once daily (qd) × 42 days. Subjects will receive the standard TMZ treatment for additional 6 cycles post BPM31510 treatment.
Intervention Type
Drug
Intervention Name(s)
BPM31510
Intervention Description
Subjects will receive a weekly, 96-h infusion of BPM31510 for a duration of 8 weeks.
Intervention Type
Other
Intervention Name(s)
Vitamin K1
Intervention Description
Subjects will receive prophylactic Vitamin K1 at a recommended dose of 10 mg Intramuscularly prior to the beginning of each week of BPM31510 therapy.
Intervention Type
Drug
Intervention Name(s)
Temozolomide (TMZ)
Intervention Description
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 additional 6 cycles post BPM31510 treatment.
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
After 2 wk of treatment with BPM31510 (ie, on Day 15), subjects will start concurrent standard RT for 42 days.
Primary Outcome Measure Information:
Title
Efficacy will be assessed by subject progression free survival
Description
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 following initiation of BPM31510.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Efficacy will be assessed by subject Overall survival
Description
Overall survival as determined by measuring from start date of BPM31510 to the date of death or date of last follow-up (for subjects who have not died).
Time Frame
5 years
Title
Safety and tolerability of BPM31510 and Vitamin K1 will be assessed by incidence of dose limiting toxicities (DLTs) and adverse events (AEs).
Description
A DLT is defined as an event possibly related to BPM31510 and clearly not due to an underlying disease or extraneous causes. An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame
28 days post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with newly diagnosed pathologically verified GB.
No prior RT, chemotherapy, immunotherapy, or targeted agents administered specifically for the lesion being treated.
Age ≥18 y.
Life expectancy ≥3 months.
Karnofsky performance score ≥60.
Adequate organ and marrow function as per protocol.
Ability for subject to understand and the willingness to sign a written ICF.
Subjects of childbearing potential must agree to use hormonal or barrier birth control with spermicidal gel to avoid pregnancy during the study.
Be at least 14 d out from surgery.
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:
Therapeutic doses of any anticoagulant, including low-molecular weight heparin. Concomitant use of warfarin, even at prophylactic doses, is prohibited.
Digoxin, digitoxin, lanatoside C, or any type of digitalis alkaloids.
Antiangiogenic drugs (ie, Avastin) either in the past 2 wk or if anticipated within the next 2 wk of informed consent.
Theophylline
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Berman, MD, PhD
Phone
617-588-0083
Email
clinicaltrials.connect@berghealth.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nathaniel DiTommaso, MS
Phone
617-588-0083
Email
clinicaltrials.connect@berghealth.com
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chirag Patil, MD,MS
Email
clinicaltrials.connect@berghealth.com
Facility Name
Stanford University Cancer Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seema Nagpal, MD
Email
clinicaltrials.connect@berghealth.com
Facility Name
Sarcoma Oncology Research Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Individual Site Status
Withdrawn
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca M Brown, MD,PhD
Email
clinicaltrials.connect@berghealth.com
Facility Name
Inova
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Learn more about this trial
A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)
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