A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)
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|ClinicalTrials.gov Identifier: NCT04752813|
Recruitment Status : Recruiting
First Posted : February 12, 2021
Last Update Posted : June 1, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Glioblastoma Multiforme||Drug: BPM31510 Other: Vitamin K1 Drug: Temozolomide (TMZ) Radiation: Radiation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
After 2 wk of treatment with BPM31510 (ie, on Day 15), subjects will start concurrent standard RT for 42 days.
- 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.
- 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).
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
- 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.
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
|Contact: Elder Granger, MD, FACP, DFACMQfirstname.lastname@example.org|
|Contact: Nathaniel DiTommaso, MSemail@example.com|
|United States, California|
|Cedars-Sinai Medical Center||Recruiting|
|Los Angeles, California, United States, 90048|
|Contact: Chirag Patil, MD,MS firstname.lastname@example.org|
|Stanford University Cancer Center||Recruiting|
|Palo Alto, California, United States, 94305|
|Contact: Seema Nagpal, MD email@example.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 firstname.lastname@example.org|
|Responsible Party:||Berg, LLC|
|Other Study ID Numbers:||
|First Posted:||February 12, 2021 Key Record Dates|
|Last Update Posted:||June 1, 2022|
|Last Verified:||August 2021|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Vitamin K 1
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Fibrin Modulating Agents