Safety and Effectiveness Evaluation of Temozolomide (Amitzo, NanoAlvand) in Patients With Grade III and IV Glioma Tumors

Sponsor
NanoAlvand
Study ID
NCT07675070
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • temozolomide — DRUG
    Temozolomide (Amitzo®, NanoAlvand), during the first five days of every 28-day cycle.

Study Details

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®.

Key Dates

First listed
Jun 30, 2026
Start date
Mar 22, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Patients receiving temozolomide (Amitzo®, NanoAlvand)

Primary Outcome Measure

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 ]

Central Contacts

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