Clinical trial · Observational
Safety and Effectiveness Evaluation of Temozolomide (Amitzo, NanoAlvand) in Patients With Grade III and IV Glioma Tumors
A Phase IV and Observational Study to Evaluate Safety and Effectiveness of Temozolomide (Amitzo, NanoAlvand) Therapy in in Patients With Grade III and IV Glioma Tumors
- 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)
This is a phase IV, post-marketing, observational, cohort study for safety and effectiveness evaluation of Amitzo® in Iranian patients with grade III and IV glioma tumors. No control group is considered in the study design. The primary objective is to evaluate the incidence of hepatic injury in patients with grade III and IV glioma tumors, treated with Amitzo®.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Grade III Glioma | — | UNRESOLVED | — |
| Grade IV Glioma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Patients receiving temozolomide (Amitzo®, NanoAlvand)
- interventionNames
- Drug: temozolomide
Primary outcomes (1)
- measure
- Assessment of the incidence of hepatic injury in patients with grade III and IV glioma tumors, receiving temozolomide (Amitzo®, NanoAlvand)
- timeFrame
- From enrollment to the end of study at 24 weeks
Secondary outcomes (2)
- measure
- Safety of temozolomide (Amitzo®, NanoAlvand) through evaluation of adverse events, based on the treating physician's assessment
- timeFrame
- From enrollment to the end of study at 24 weeks
- description
- * Frequency of causality assessments of adverse events in patients with grade III and IV glioma tumors, treated with temozolomide (Amitzo®, NanoAlvand) * Severity of adverse events occurring in patients with grade III and IV glioma tumors, treated with temozolomide (Amitzo®, NanoAlvand) * Incidence of serious adverse events (SAEs) in patients with grade III and IV glioma tumors, treated with temozolomide (Amitzo®, NanoAlvand)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with newly diagnosed grade III or IV glial tumors, or patients who have experienced disease recurrence or progression after receiving standard treatment and, based on the treating physician's diagnosis, require treatment with temozolomide * Patients aged 18-80 years old Exclusion Criteria: * Patients without a baseline MRI * Patients who are unwilling to participate in the study
References
Publications (0)
Data not yet available