GliosarcomaPhase 1NCT03020602
BPM31510 in Treating Patients With Recurrent High-Grade Glioma Previously Treated With Bevacizumab
A Phase 1 study testing Laboratory Biomarker Analysis, Pharmacological Study and Ubidecarenone Injectable Nanosuspension in people with Gliosarcoma and Recurrent Glioblastoma, run by Seema Nagpal at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of ubidecarenone injectable nanosuspension (BPM31510) in treating patients with high-grade glioma (anaplastic astrocytoma or glioblastoma) that has come back and have been previously treated with bevacizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gliosarcoma, Recurrent Glioblastoma, Astrocytoma of Brain
- What is being tested?
- Laboratory Biomarker Analysis, Pharmacological Study and Ubidecarenone Injectable Nanosuspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2017to 26 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be ≥ 18 years of age
- Have a life expectancy ≥ 6 weeks
- Have a Karnofsky Performance Score (KPS) ≥ 60
- Have pathologically proven GB, gliosarcoma (WHO IV), or anaplastic astrocytoma (WHO III) in recurrence after treatment with bevacizumab
- Be at least 14 days from the last administration of bevacizumab
- Be at least 28 days from last administration of cytotoxic chemotherapy or other investigational agent
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- Have received radiation therapy with concurrent temozolomide. Total radiation dosage can range from 5400 to 6000 cGy administered in daily fractions of 150 to 200 cGy over 6 weeks, or the equivalent in a hypofractionated protocol (for example, 4000cGy in 15 fractions or 2500cGy in 5 fractions). Patients who are MGMT negative do not need to have received temozolomide.
- Have adequate organ and marrow function as follows (all required):
- ANC ≥ 1500 mm3
- Platelets ≥ 100,000/mm3
- Hemoglobin ≥ 9 g/dL
- Serum creatinine ≤ 1.8 mg/dL or creatinine clearance > 50 mL/min Bilirubin ≤ 1.5 mg/dL
- Alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)
- Aspartate transaminase (AST) ≤ 2.5 x ULN
- Prothrombin time (PT) ≤ 1.5 x ULN
- International Normalized Ratio (INR) ≤ 1.5 x ULN
- Partial thromboplastin time (PTT) ≤ 1.5 x ULN
- Subjects of childbearing potential must agree to use hormonal or barrier birth control with spermicidal gel to avoid pregnancy during the study
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Has a history of spontaneous or tumor related cerebral hemorrhage; or has cerebral hemorrhage as determined by the screening FDG PET CT and MRI. This does not include stable post operative blood products seen on a gradient echo MRI sequence.
- Has the any of the following cardiac history:
- Active heart disease including myocardial infarction within previous 3 months
- Symptomatic coronary artery disease
- Arrhythmias not controlled by medication
- Unstable angina pectoris
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- Uncontrolled or symptomatic congestive heart failure (NYHA class III and IV) 3.2.3 Uncontrolled or severe coagulopathies or a history of clinically significant bleeding within the past 6 months, including any of the following, but not limited to:
- Epistaxis
- Hemoptysis
- Hematochezia
- Hematuria
- Gastrointestinal bleeding
- Spontaneous or tumor related intracranial hemorrhage
- Known predisposition for bleeding such as von Willebrand's disease or other such condition(s)
- Uncontrolled concurrent illness that would limit compliance with study requirements, including any of the following, but limited to:
- Uncontrolled infection.
- Psychiatric illness/social situations
- 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 years prior to 1st dose of investigational drug
- Receiving any of the following medications:
- Therapeutic doses of any anticoagulant, including low molecular weight heparin (LMWH). Concomitant use of warfarin, even at prophylactic doses, is prohibited
- Digoxin, digitoxin, lanatoside C, or any type of digitalis alkaloids.
- Colony stimulating factors (CSFs) that cannot be held during the monitoring period for dose limiting toxicities (DLT)
- Has significant toxicities from prior treatment that have not resolved or stabilized
- Known allergy to Coenzyme Q10
- Known allergy or adverse reaction to oral, subcutaneous, or intravenous vitamin K
- Is 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Palo Alto, California, 94304
About this study
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
This phase I trial studies the side effects and best dose of ubidecarenone injectable nanosuspension (BPM31510) in treating patients with high-grade glioma (anaplastic astrocytoma or glioblastoma) that has come back and have been previously treated with bevacizumab. BPM31510 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
Primary Objective:
- 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.
Secondary Objectives:
- To evaluate plasma pharmacokinetics (PK) when BPM31510 plus vitamin K is given to subjects with HGG recurrent on a BEV containing regimen.
Exploratory Objectives:
- 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.
- Being tested
- Laboratory Biomarker Analysis, Pharmacological Study, Ubidecarenone Injectable Nanosuspension
- Medical subject headings
- Gliosarcoma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Correlative studies
Ubidecarenone Injectable NanosuspensionDrug
Also called BP31510, Coenzyme Q10 Injectable Nanosuspension, Ubiquinone Injectable Nanosuspension
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (BPM31510) | Experimental | 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. Receives: Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Ubidecarenone Injectable Nanosuspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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).
Measured: Up to 28 days
Secondary outcomes (1)
Incidence of adverse events graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version (v)4.03
Will be tabulated separately for each dose cohort, by Medical Dictionary for Regulatory Activities (MedDRA) major organ system and severity.
Measured: Up to 30 days after last dose of BPM3150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start4 Jan 2017
- Primary completion4 Apr 2019
- Study completion26 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seema Nagpal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seema Nagpal, Stanford University
- Investigators
- Seema Nagpal, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020602
- Sponsor's protocol ID
- IRB-38514
- Other IDs
- NCI-2016-01973, BRN0035
- Status last verified
- Aug 2021
- First submitted
- 5 Jan 2017
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03020602
- Acronym / sponsor ID
- IRB-38514
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Seema NagpalUniversity, hospital or other
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 4 Apr 2019 (actual)
- Study completion
- 26 Jun 2021 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I trial studies the side effects and best dose of ubidecarenone injectable nanosuspension (BPM31510) in treating patients with high-grade glioma (anaplastic astrocytoma or glioblastoma) that has come back and have been previously treated with bevacizumab. BPM31510 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description
Primary Objective:
- 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.
Secondary Objectives:
- To evaluate plasma pharmacokinetics (PK) when BPM31510 plus vitamin K is given to subjects with HGG recurrent on a BEV containing regimen.
Exploratory Objectives:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (BPM31510) | Experimental | Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Drug: Ubidecarenone Injectable NanosuspensionPatients receive ubidecarenone injectable nanosuspension IV over 72 hours twice weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Be ≥ 18 years of age
- Have a life expectancy ≥ 6 weeks
- Have a Karnofsky Performance Score (KPS) ≥ 60
- Have pathologically proven GB, gliosarcoma (WHO IV), or anaplastic astrocytoma (WHO III) in recurrence after treatment with bevacizumab
- Be at least 14 days from the last administration of bevacizumab
Key exclusion criteria (27 listed)
- Has a history of spontaneous or tumor related cerebral hemorrhage; or has cerebral hemorrhage as determined by the screening FDG PET CT and MRI. This does not include stable post operative blood products seen on a gradient echo MRI sequence.
- Has the any of the following cardiac history:
- Known predisposition for bleeding such as von Willebrand's disease or other such condition(s)
- Uncontrolled concurrent illness that would limit compliance with study requirements, including any of the following, but limited to:
- 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 years prior to 1st dose of investigational drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (BPM31510) |
| Pharmacological StudyCorrelative studies | Other | Treatment (BPM31510) |
| Ubidecarenone Injectable NanosuspensionAlso: BP31510, Coenzyme Q10 Injectable Nanosuspension, Ubiquinone Injectable NanosuspensionGiven IV | Drug | Treatment (BPM31510) |
Primary outcome
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).
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seema Nagpal principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Laboratory Biomarker Analysis, Pharmacological Study and Ubidecarenone Injectable Nanosuspension in people with Gliosarcoma and Recurrent Glioblastoma, run by Seema Nagpal at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.