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NCT07675070
Safety and Effectiveness Evaluation of Temozolomide (Amitzo, NanoAlvand) in Patients With Grade III and IV Glioma Tumors
Conditions: Brain Tumor, Grade III Glioma, Grade IV Glioma
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Enrollment: 100
Sponsor: NanoAlvand
Location: Orchid Pharmed Tehran
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®.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07675070). StuddyBuddy aggregates publicly available trial information.