GlioblastomaPhase 1NCT03687034
A Study of the Safety and Pharmacokinetics of BRCX014 in Patients With Glioblastoma
A Phase 1 study testing Temozolomide and Optune in people with Glioblastoma, run by Leaf Vertical Inc..
Trial summary
An Open-Label, Multi-Center Study to Assess the Safety and Pharmacokinetics of BRCX014 Combined with Standard-of-Care Treatment in Subjects with Glioblastoma Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Temozolomide and Optune
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2019to 31 Dec 2020
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed glioblastoma (astrocytoma WHO grade IV)
- MGMT promoter methylation status is negative
- Brain MRI confirmation of disease according to RANO (Response Assessment in Neuro-Oncology) criteria
- Completion of standard-of-care temozolomide-based chemoradiation for post-operative treatment of glioblastoma plus two-to-six week "washout" period and stable-to-improved baseline brain MRI.
- Male and female subjects between the ages of 18 and 85 years
- Karnofsky Performance Score ≥ 60%
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- Expected survival of at least six months from the day of enrollment
- No severe dysfunction of major organs (e.g., bone marrow, liver, kidneys, heart, lungs, etc.) and laboratory results from up to 14 days prior to enrollment fall within criteria:
- Hemoglobin > 10 g/dL
- Leukocytes ≥ 3,000 per μl
- Absolute neutrophil count ≥ 1,500 per μl
- Platelet count > 100,000 per μl
- BUN < 25 mg
- Serum creatinine within normal institutional limits OR Creatinine clearance ≥ 60 ml/min/1.73 m2 for patients with creatinine levels above institutional normal
- Total serum bilirubin within normal institutional limits
- ALT (SGPT) ≤ 2.5× the institutional upper limit of normal OR AST (SGOT) ≤ 2.5× the institutional upper limit of normal
- Ability to take medication sublingually
- Willingness and ability to comply with scheduled visits, laboratory tests, and other trial procedures
- Accessible for treatment and follow-up
- Female subjects: Use of two approved forms of contraceptives
- Male subjects: Use of two approved forms of contraceptives and willing to instruct their partners to use one form of contraceptive as well
- Ability to understand and willingness to sign a written informed consent document
Who cannot join
- MGMT promoter methylation status is positive (i.e., promoter is methylated)
- Prior radiotherapy for GBM within two (2) weeks of entering the study or has not recovered from adverse events due to agents administered more than four (4) weeks earlier
- Prior chemotherapy, immunotherapy, or radiation therapy for other cancers (except for treatment of limited curable skin cancers)
- Currently or recently (in the previous six months) part of a clinical trial involving any other investigational agents
- Hypersensitivity or allergy to any ingredient in the study drug
- Receiving any medications or substances that are known substantial inhibitors or inducers of CYP3A4
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- Consumption of grapefruit or grapefruit juice three (3) days prior to screening or unwillingness to abstain from consuming grapefruit in any form during the study
- Uncontrolled intercurrent illness that would limit compliance with study requirements
- Pregnancy, possible pregnancy, plans for pregnancy, or active lactation or nursing
- Positive HIV or hepatitis status
- Unwillingness or inability to take medication sublingually
- Diagnosis of cancer more than 120 days prior to initial visit
- History of prior malignancy except curatively treated skin cancers
- History of prior chemotherapy or radiation for other cancers (except for treatment of limited curable skin cancers) before initial visit
- Clinically significant unstable medical conditions other than GBM
- Clinically relevant symptoms or clinically significant illness in the four (4) weeks prior to screening or registration, other than GBM
- Clinically significant unstable medical conditions, other than GBM, deemed by the investigator to pose an unacceptable risk to the patient
- History of substance abuse within the last two years
- Current use of recreational or medicinal cannabis, synthetic cannabinoid-based medications, or alcohol, or planned use while in the study
- Evidence of any diseases or conditions that may interfere with the study or interpretation of study results
- Inability or unwillingness to cooperate with the study procedures
- Known history of severe depression or psychiatric disorders, or active suicidal ideation
- Subjects with close affiliation with an investigational site
- Absence of or unwillingness to sign and date the informed consent document
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase I Study of BRCX014 to Investigate Dose-Ranging Safety and Pharmacokinetics in Adults With Glioblastoma (GBM) and Non-Methylated MGMT Gene Status
An Open-Label, Multi-Center Study to Assess the Safety and Pharmacokinetics of BRCX014 Combined with Standard-of-Care Treatment in Subjects with Glioblastoma
Read the detailed description
Several studies have shown a possible anti-tumor role for cannabinoids by modulating cell signaling pathways, inhibiting angiogenesis, inducing apoptosis, and overcoming chemotherapy resistance. The investigators seek to demonstrate the safety profile of BRCX014, a cannabinoid formulation, when given to glioblastoma patients in conjunction with standard-of-care therapy.
- Conditions
- Glioblastoma
- Being tested
- Temozolomide, Optune
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Also called Temodar
Standard-of-care chemotherapy for patients with glioblastoma includes concurrent radiation therapy (2 Gy per day for a total of 60 Gy) and temozolomide (75 mg per square meter of body- surface area per day, seven days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for five days during each 28-day cycle).
OptuneDevice
Also called TTFields
Standard-of-care treatment for glioblastoma includes alternating electric-field therapy, or Optune, as a Category 1 treatment in conjunction with temozolomide after maximal safe resection and completion of radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| BRCX014 | Experimental | Subjects will receive escalating doses of BRCX014 in conjunction with standard-of-care (SOC) treatment. For patients with GBM, following standard chemo-radiation treatment (radiation: 2 Gy per day for a total of 60 Gy; and temozolomide: 75 mg per square meter of body-surface area per day, seven days per week from the first to the last day of radiotherapy), SOC treatment comprises six cycles of adjuvant temozolomide (150 to 200 mg per square meter for five days during each 28-day cycle), with or without use of alternating electric field therapy (Optune device). Receives: Drug: Temozolomide; Device: Optune |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
The primary objective of this study is to evaluate the safety and tolerability of BRCX014 using clinical assessments and lab results.
Measured: Through study completion, an average of one year
Secondary outcomes (3)
Maximum tolerated dose
A secondary objective of this study is to identify the maximum tolerated dose of BRCX014.
Measured: Through study completion, an average of one year
Levels of metabolites
A secondary objective of this study is to perform pharmacokinetics analyses by measuring the plasma concentrations of BRCX014, temozolomide, and their major metabolites using lab results.
Measured: Through study completion, an average of one year
Progression-free survival
A secondary objective of this study is to measure PFS using lab results and radiographic data.
Measured: Through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start1 Jun 2019 (estimated)
- Primary completion30 Sep 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies 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
- Model description
- This study consists of dose escalations that follow the standard 3+3 design, proceeding until the maximum tolerated dose is attained. The treatment period for patients in this study at each dose will be one year.
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leaf Vertical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Avgeropoulos, MD, Principal investigator, Orlando Health / UF Health Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687034
- Sponsor's protocol ID
- Olympian 2
- Status last verified
- Feb 2019
- First submitted
- 22 Aug 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of BRCX014 to Investigate Dose-Ranging Safety and Pharmacokinetics in Adults With Glioblastoma (GBM) and Non-Methylated MGMT Gene Status
- ClinicalTrials.gov ID
- NCT03687034
- Acronym / sponsor ID
- Olympian 2
- Conditions
- Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Leaf Vertical Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 27 Sep 2018 (actual)
- 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.
An Open-Label, Multi-Center Study to Assess the Safety and Pharmacokinetics of BRCX014 Combined with Standard-of-Care Treatment in Subjects with Glioblastoma
Detailed description
Several studies have shown a possible anti-tumor role for cannabinoids by modulating cell signaling pathways, inhibiting angiogenesis, inducing apoptosis, and overcoming chemotherapy resistance. The investigators seek to demonstrate the safety profile of BRCX014, a cannabinoid formulation, when given to glioblastoma patients in conjunction with standard-of-care therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study consists of dose escalations that follow the standard 3+3 design, proceeding until the maximum tolerated dose is attained. The treatment period for patients in this study at each dose will be one year.
| Arm | Type | Receives |
|---|---|---|
| BRCX014 | Experimental | Drug: Temozolomide, Device: OptuneSubjects will receive escalating doses of BRCX014 in conjunction with standard-of-care (SOC) treatment. For patients with GBM, following standard chemo-radiation treatment (radiation: 2 Gy per day for a total of 60 Gy; and temozolomide: 75 mg per square meter of body-surface area per day, seven days per week from the first to the last day of radiotherapy), SOC treatment comprises six cycles of adjuvant temozolomide (150 to 200 mg per square meter for five days during each 28-day cycle), with or without use of alternating electric field therapy (Optune device). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histopathologically confirmed glioblastoma (astrocytoma WHO grade IV)
- MGMT promoter methylation status is negative
- Brain MRI confirmation of disease according to RANO (Response Assessment in Neuro-Oncology) criteria
- Completion of standard-of-care temozolomide-based chemoradiation for post-operative treatment of glioblastoma plus two-to-six week "washout" period and stable-to-improved baseline brain MRI.
- Male and female subjects between the ages of 18 and 85 years
Key exclusion criteria (24 listed)
- MGMT promoter methylation status is positive (i.e., promoter is methylated)
- Prior radiotherapy for GBM within two (2) weeks of entering the study or has not recovered from adverse events due to agents administered more than four (4) weeks earlier
- Prior chemotherapy, immunotherapy, or radiation therapy for other cancers (except for treatment of limited curable skin cancers)
- Currently or recently (in the previous six months) part of a clinical trial involving any other investigational agents
- Hypersensitivity or allergy to any ingredient in the study 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 |
|---|---|---|
| TemozolomideAlso: TemodarStandard-of-care chemotherapy for patients with glioblastoma includes concurrent radiation therapy (2 Gy per day for a total of 60 Gy) and temozolomide (75 mg per square meter of body- surface area per day, seven days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for five days during each 28-day cycle). | Drug | BRCX014 |
| OptuneAlso: TTFieldsStandard-of-care treatment for glioblastoma includes alternating electric-field therapy, or Optune, as a Category 1 treatment in conjunction with temozolomide after maximal safe resection and completion of radiation therapy. | Device | BRCX014 |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Through study completion, an average of one year
The primary objective of this study is to evaluate the safety and tolerability of BRCX014 using clinical assessments and lab results.
3 secondary outcomes
Maximum tolerated dose
Time frame: Through study completion, an average of one year
Levels of metabolites
Time frame: Through study completion, an average of one year
Progression-free survival
Time frame: Through study completion, an average of one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Glioblastoma
Active, not recruitingPhase 3
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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.
Nicholas Avgeropoulos, MD principal investigator
Orlando Health / UF Health Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Temozolomide and Optune in people with Glioblastoma, run by Leaf Vertical Inc..
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 22 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip A Arlen, PhD (4074430656, parlen@leafvertical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: Through study completion, an average of one year). 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 26 Feb 2019.