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Safety and Effectiveness Evaluation of Temozolomide (Amitzo, NanoAlvand) in Patients With Grade III and IV Glioma Tumors
Sponsor: NanoAlvand
Summary
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®.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2026-03-22
Completion Date
2026-11
Last Updated
2026-06-30
Healthy Volunteers
No
Interventions
temozolomide
Temozolomide (Amitzo®, NanoAlvand), during the first five days of every 28-day cycle.
Locations (1)
Orchid Pharmed
Tehran, Iran