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Recruiting 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07675070). StuddyBuddy aggregates publicly available trial information.