NCT04373785Not yet recruitingPhase 1/2
NG101m Adjuvant Therapy in Glioblastoma Patients
A Multi-Center Pilot/Phase I and Phase II Clinical Trial of NG101m Adjuvant Therapy in Newly Diagnosed Glioblastoma Patients
Source: ClinicalTrials.gov · Last updated 21 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 the standard treatment of temozolomide and radiation.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 30 Apr 2020
- Start date
- 1 Jan 2027
- Primary completion date
- 30 Jul 2030
- Lead sponsor
- NeuGATE Theranostics
- Diseases
- Glioblastoma
- NCT number
- NCT04373785
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 52
- From 1 Jan 2027 to the primary completion date, 30 Jul 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Corticosteroid therapy that cannot be tapered down to a dose of 1 - 2 mg/day of dexamethasone or its equivalent
Other illness
- 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
- History of immunodeficiency diseases or autoimmune diseases
- History of peptic ulcer disease or gastrointestinal perforation
Other
- Pregnant women
- Breastfeeding women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yvonne Kew MD, PLLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.