A Study of the Safety and Pharmacokinetics of BRCX014 in Patients With Glioblastoma (NCT03687034) | Clinical Trial Compass
UnknownPhase 1
A Study of the Safety and Pharmacokinetics of BRCX014 in Patients With Glioblastoma
21 participantsStarted 2019-06-01
Plain-language 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
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Timeframe: Through study completion, an average of one year