Status:
NOT_YET_RECRUITING
NG101m Adjuvant Therapy in Glioblastoma Patients
Lead Sponsor:
NeuGATE Theranostics
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this clinical trial is to evaluate the addition of NG101m adjuvant therapy to standard of care treatment of glioblastoma multiforme. All subjects will receive NG101m capsules along with...
Detailed Description
Glioblastoma multiforme (GBM) is the most lethal form of malignant brain cancer, with about 12,000 new cases diagnosed each in the the United States. The current standard treatment consists of maximal...
Eligibility Criteria
Inclusion
- Male or female subjects ≥ 18 years of age
- Must be newly diagnosed with GBM
- Primary treatment must consist of a chemoradiation therapy (CRT) regimen
- Hemoglobin \> 9 g/dL
- White blood count 3,600 - 11,000/mm3
- Absolute neutrophil count (ANC) ≥ 1,500/mm3
- Absolute lymphocyte count (ALC) ≥ 1,000/mm3
- Platelet count 100,000/mm3
- BUN ≤ 1.5 times upper limit of normal
- Creatinine clearance rate \> 40 mL/min
- ALT ≤ 3 times upper limit of normal
- AST ≤ 3 times upper limit of normal
- Alkaline phosphatase ≤ 3 times upper limit of normal
- Total bilirubin ≤ 2.0 mg/dL
- Karnofsky Performance Status ≥ 70
- Must not be on any other alternative therapies
- Not pregnant
Exclusion
- Known hypersensitivity to meloxicam, famotidine, and/or caffeine or any of their derivatives or components
- Known allergy to vitamin A, vitamin D3, and/or L-citrulline
- Pregnant women
- Breastfeeding women
- Corticosteroid therapy that cannot be tapered down to a dose of 1 - 2 mg/day of dexamethasone or its equivalent
- History of immunodeficiency diseases or autoimmune diseases
- History of peptic ulcer disease or gastrointestinal perforation
Key Trial Info
Start Date :
January 1 2027
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04373785
Start Date
January 1 2027
End Date
December 31 2030
Last Update
October 21 2025
Active Locations (1)
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1
Yvonne Kew MD, PLLC
Houston, Texas, United States, 77030