Brain Tumor, Grade III Glioma, Grade IV Glioma
Conditions
Keywords
Brain Neoplasms, Temozolomide, Effectiveness, Safety, Glioma, Amitzo, Adverse Event
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®.
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
DRUGtemozolomide
Temozolomide (Amitzo®, NanoAlvand), during the first five days of every 28-day cycle.
Sponsors
NanoAlvand
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | * Frequency of causality assessments of adverse events in patients with grade III and IV glioma tumors, treated with temozolomide (Amitzo®, NanoAlvand) * Severity of adverse events occurring in patients with grade III and IV glioma tumors, treated with temozolomide (Amitzo®, NanoAlvand) * Incidence of serious adverse events (SAEs) in patients with grade III and IV glioma tumors, treated with temozolomide (Amitzo®, NanoAlvand) |
| 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 | — |
Countries
Iran
Contacts
CONTACTNassim Anjidani, PharmD
PRINCIPAL_INVESTIGATORmohadese shahin, Assistant Professor
Iran University of Medical Sciences
Outcome results
None listed