Clinical trial · Interventional
A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)
NCT04752813CI-TRIAL-00101586active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BPM31510 | Drug | — | UNRESOLVED |
| Radiation | Radiation | — | UNRESOLVED |
| Temozolomide (TMZ) | Drug | Temozolomide | ALIAS |
| Vitamin K1 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BPM31510, Vitamin K1, RT and TMZ
- 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 subcutaneously 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 up to 12 cycles post BPM31510 treatment.
- interventionNames
- Drug: BPM31510
- Other: Vitamin K1
- Drug: Temozolomide (TMZ)
- Radiation: Radiation
Primary outcomes (1)
- measure
- Efficacy will be assessed by subject progression free survival
- timeFrame
- 6 months and 12 months
- 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 and 12 mo following initiation of BPM31510.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 15 d out and not more than 50 d from surgery.
Exclusion Criteria:
1. History of clinically significant tumor-related cerebral hemorrhage.
2. Patients with multicentric disease defined by tumors which have multiple discrete areas of contrast-enhancing tumor without connecting T2/FLAIR signal abnormality.
3. Patients with diffuse leptomeningeal disease.
4. Patients who are not eligible for definitive surgical resection.
5. Patients on decadron daily dosing more than 2 mg.
6. Any serious cardiac history as per protocol.
7. Uncontrolled or severe coagulopathies or a history of clinically significant bleeding within the past 6 months.
8. Known predisposition for bleeding such as von Willebrand's disease or other such condition(s).
9. Uncontrolled concurrent illness.
10. 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.
11. 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
12. Known allergy to CoQ10.
13. Known allergy or adverse reaction to Vitamin K1.
14. Pregnant or lactating.
15. 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.
16. Patients with a contraindication to radiation.References
Publications (0)
Data not yet available
No reference posted for this study.