Temozolomide safety and effectiveness in adults with Grade III–IV glioma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a post-marketing, observational cohort study in Iranian adults with newly diagnosed or recurrent Grade III or IV glioma treated with temozolomide (Amitzo). The study uses a single-arm design with 100 participants and collects safety and effectiveness data over six treatment visits and a follow-up. Physicians complete a data booklet to document hepatic safety and other outcomes during the first 5 days of each 28-day cycle. The primary objective is to determine the incidence of hepatic injury in patients receiving Amitzo®, with secondary observations on overall safety and potential effectiveness signals. Enrollment is limited to adults aged 18–80 and requires imaging baseline, with no control group for comparison.

Why it matters

Who can join: the full rules

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

Where it's running

• Orchid Pharmed
  Tehran, Iran Recruiting

Study contacts

• Principal investigator: mohadese shahin, Assistant Professor — Iran University of Medical Sciences
• Study coordinator: Nassim Anjidani, PharmD
• Email: anjidani.n@orchidpharmed.com
• Phone: +982143473000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.