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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Islamic Republic of Iran
Orchid Pharmed
RECRUITING
Tehran
Contact Information
Primary
Nassim Anjidani, PharmD
anjidani.n@orchidpharmed.com
+982143473000
Time Frame
Start Date: 2026-03-22
Estimated Completion Date: 2026-11
Participants
Target number of participants: 100
Treatments
Patients receiving temozolomide (Amitzo®, NanoAlvand)
Related Therapeutic Areas
Sponsors
Leads: NanoAlvand