Clinical trial · Interventional
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
NCT04373785CI-TRIAL-00096699not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensity-modulated radiation therapy | Radiation | — | UNRESOLVED |
| NG101m | Drug | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NG101m and standard treatment
- description
- Concomittant therapy: Radiation therapy, oral temozolomide, and oral NG101m Adjuvant therapy: Oral temozolomide and oral NG101m
- interventionNames
- Radiation: Intensity-modulated radiation therapy
- Drug: Temozolomide
- Drug: NG101m
Primary outcomes (2)
- measure
- Number of participants with treatment-emergent adverse events and serious adverse events
- timeFrame
- 1 month
- description
- Safety and tolerability of NG101m as adjuvant therapy to chemoradiation therapy
- measure
- Efficacy of NG101m adjuvant chemoradiation therapy assessed by measuring 2-year overall survival rate.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.