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

NCT07675070 | Recruiting DMC

• 1 other identifier: TEM.NA.MS.IV.05
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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®.

Conditions

Brain Tumor; Grade III Glioma; Grade IV Glioma

Keywords

Brain Neoplasms; Temozolomide; Effectiveness; Safety; Glioma; Amitzo; Adverse Event

Outcome Measures

Primary Outcomes (1)

• Assessment of the incidence of hepatic injury in patients with grade III and IV glioma tumors, receiving temozolomide (Amitzo®, NanoAlvand)

  From enrollment to the end of study at 24 weeks

Secondary Outcomes (2)

• Safety of temozolomide (Amitzo®, NanoAlvand) through evaluation of adverse events, based on the treating physician's assessment

  From enrollment to the end of study at 24 weeks

• Response to temozolomide (Amitzo®, NanoAlvand) by evaluating the Overall Response Rate (ORR) in patients, based on the treating physician's assessment or magnetic resonance imaging (MRI) findings

  Week 24

Study Arms (1)

Patients receiving temozolomide (Amitzo®, NanoAlvand)

Drug: temozolomide

Interventions

temozolomide DRUG

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

Patients receiving temozolomide (Amitzo®, NanoAlvand)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 100 Iranian patients diagnosed with grade III or IV gliomas and treated with Amitzo® will be enrolled in the study.

You may qualify if:

• 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

You may not qualify if:

• Patients without a baseline MRI
• Patients who are unwilling to participate in the study

Sponsors & Collaborators

• NanoAlvand: lead

Study Sites (1)

Orchid Pharmed

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Glioma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• mohadese shahin, Assistant Professor

  Iran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nassim Anjidani, PharmD

CONTACT

+982143473000; anjidani.n@orchidpharmed.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: March 22, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

IR (1)