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A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04752813
Recruitment Status : Recruiting
First Posted : February 12, 2021
Last Update Posted : June 1, 2022
Sponsor:
Information provided by (Responsible Party):
Berg, LLC

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.

Condition or disease Intervention/treatment Phase
Glioblastoma Glioblastoma Multiforme Drug: BPM31510 Other: Vitamin K1 Drug: Temozolomide (TMZ) Radiation: Radiation Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)
Actual Study Start Date : August 2, 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : September 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin K

Arm Intervention/treatment
Experimental: BPM31510, Vitamin K1, RT and TMZ

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.

Drug: BPM31510
Subjects will receive a weekly, 96-h infusion of BPM31510 for a duration of 8 weeks.

Other: Vitamin K1
Subjects will receive prophylactic Vitamin K1 at a recommended dose of 10 mg Intramuscularly prior to the beginning of each week of BPM31510 therapy.

Drug: Temozolomide (TMZ)
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.

Radiation: Radiation
After 2 wk of treatment with BPM31510 (ie, on Day 15), subjects will start concurrent standard RT for 42 days.




Primary Outcome Measures :
  1. Efficacy will be assessed by subject progression free survival [ Time Frame: 6 months ]
    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 :
  1. Efficacy will be assessed by subject Overall survival [ Time Frame: 5 years ]
    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).

  2. Safety and tolerability of BPM31510 and Vitamin K1 will be assessed by incidence of dose limiting toxicities (DLTs) and adverse events (AEs). [ Time Frame: 28 days post treatment ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects with newly diagnosed pathologically verified GB.
  2. No prior RT, chemotherapy, immunotherapy, or targeted agents administered specifically for the lesion being treated.
  3. Age ≥18 y.
  4. Life expectancy ≥3 months.
  5. Karnofsky performance score ≥60.
  6. Adequate organ and marrow function as per protocol.
  7. Ability for subject to understand and the willingness to sign a written ICF.
  8. Subjects of childbearing potential must agree to use hormonal or barrier birth control with spermicidal gel to avoid pregnancy during the study.
  9. Be at least 14 d out from surgery.

Exclusion Criteria:

  1. No evidence of residual tumor.
  2. History of clinically significant tumor-related cerebral hemorrhage.
  3. Any serious cardiac history as per protocol.
  4. Uncontrolled or severe coagulopathies or a history of clinically significant bleeding within the past 6 months.
  5. Known predisposition for bleeding such as von Willebrand's disease or other such condition(s).
  6. Uncontrolled concurrent illness.
  7. 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.
  8. Receiving any of the following medications:

    1. Therapeutic doses of any anticoagulant, including low-molecular weight heparin. Concomitant use of warfarin, even at prophylactic doses, is prohibited.
    2. Digoxin, digitoxin, lanatoside C, or any type of digitalis alkaloids.
    3. Antiangiogenic drugs (ie, Avastin) either in the past 2 wk or if anticipated within the next 2 wk of informed consent.
    4. Theophylline
  9. Known allergy to CoQ10.
  10. Known allergy or adverse reaction to oral, subcutaneous, or IV Vitamin K1.
  11. Pregnant or lactating.
  12. 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.

Information from the National Library of Medicine

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): NCT04752813


Contacts
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Contact: Elder Granger, MD, FACP, DFACMQ 617-588-0083 clinicaltrials.connect@berghealth.com
Contact: Nathaniel DiTommaso, MS 617-588-0083 clinicaltrials.connect@berghealth.com

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Chirag Patil, MD,MS       clinicaltrials.connect@berghealth.com   
Stanford University Cancer Center Recruiting
Palo Alto, California, United States, 94305
Contact: Seema Nagpal, MD       clinicaltrials.connect@berghealth.com   
Sarcoma Oncology Research Center Withdrawn
Santa Monica, California, United States, 90403
United States, New York
Mount Sinai Hospital Not yet recruiting
New York, New York, United States, 10029
Contact: Rebecca M Brown, MD,PhD       clinicaltrials.connect@berghealth.com   
Sponsors and Collaborators
Berg, LLC
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Responsible Party: Berg, LLC
ClinicalTrials.gov Identifier: NCT04752813    
Other Study ID Numbers: BPM31510IV-11
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Vitamin K
Vitamin K 1
Temozolomide
Vitamins
Micronutrients
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants