Safety and Effectiveness Evaluation of Temozolomide (Amitzo, NanoAlvand) in Patients With Grade III and IV Glioma Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: temozolomide.
- Who it may be relevant to
- Registry conditions: Brain Tumor, Grade III Glioma, Grade IV Glioma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Iran
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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®.
Detailed description
This is a phase IV, post-marketing, observational, cohort study to evaluate the safety and effectiveness of Amitzo® in Iranian patients with grade III and IV glioma tumors. To gather the data during the predefined six intervention visits and one follow-up visit of the study, a booklet will be filled by the designated physician. The treatment will be administered during the first 5 days of each 28-day treatment cycle. The primary objective of this study is to evaluate the incidence of hepatic injury in patients with brain tumors treated with Amitzo®. This is a single arm study with a calculated sample size of 100 patients.
Interventions
- Drug temozolomide
Temozolomide (Amitzo®, NanoAlvand), during the first five days of every 28-day cycle.
Primary outcome measures
- 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]
Secondary outcome measures (2)
- Safety of temozolomide (Amitzo®, NanoAlvand) through evaluation of adverse events, based on the treating physician's assessment [Time frame: 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 [Time frame: Week 24]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Iran · 1 center
- Orchid Pharmed — Tehran
Identifiers
NCT: NCT07675070 · TEM.NA.MS.IV.05