An observational study in Brain Tumor, Grade III Glioma and Grade IV Glioma, sponsored by NanoAlvand. Recruiting at 1 site in Iran. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by NanoAlvand · Observational
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®.
This is a phase IV, post-marketing, observational, cohort study to evaluate the safety and effectiveness of Amitzo® in Iranian patients with grade III and IV glioma tumors. To gather the data during the predefined six intervention visits and one follow-up visit of the study, a booklet will be filled by the designated physician. The treatment will be administered during the first 5 days of each 28-day treatment cycle. The primary objective of this study is to evaluate the incidence of hepatic injury in patients with brain tumors treated with Amitzo®. This is a single arm study with a calculated sample size of 100 patients.
2,440 studies on the registry are indexed under Brain Neoplasms; 540 are open to participants now.
This study's planned enrollment of 100 is close to the median of 99 across 433 observational studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →NanoAlvand is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
A total of 100 Iranian patients diagnosed with grade III or IV gliomas and treated with Amitzo® will be enrolled in the study.
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Exclusion Criteria:
Drug: temozolomide
Temozolomide (Amitzo®, NanoAlvand), during the first five days of every 28-day cycle.
Assessment of the incidence of hepatic injury in patients with grade III and IV glioma tumors, receiving temozolomide (Amitzo®, NanoAlvand)
Time frame: From enrollment to the end of study at 24 weeks
Safety of temozolomide (Amitzo®, NanoAlvand) through evaluation of adverse events, based on the treating physician's assessment
* 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)
Time frame: From enrollment to the end of study at 24 weeks
Response to temozolomide (Amitzo®, NanoAlvand) by evaluating the Overall Response Rate (ORR) in patients, based on the treating physician's assessment or magnetic resonance imaging (MRI) findings
Time frame: Week 24
Plan to share: Undecided — Data regarding this study will be shared, upon reasonable request from the investigator.
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Sep 2026, 6 months after the start.
Of 199 observational studies under Brain Neoplasms, half reached primary completion within 82 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 269. This study's planned 6 months is below that.
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