A Study of the Safety and Pharmacokinetics of BRCX014 in Patients With Glioblastoma

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leaf Vertical Inc.
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• 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%

• 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

Exclusion Criteria:

• 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

• 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