Brain TumorNCT07675070
Safety and Effectiveness Evaluation of Temozolomide (Amitzo, NanoAlvand) in Patients With Grade III and IV Glioma Tumors
An observational study of Brain Tumor and Grade III Glioma, run by NanoAlvand at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Tumor, Grade III Glioma, Grade IV Glioma
- What is being tested?
- temozolomide
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- 22 Mar 2026to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients without a baseline MRI
- Patients who are unwilling to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iran1 site, 1 recruiting
- Recruiting
Orchid Pharmed
Tehran
Hamidreza Kafi, +989129232594, Kafi.H@Orchidpharmed.com
About this study
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
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®.
Read the 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.
- Conditions
- Brain Tumor, Grade III Glioma, Grade IV Glioma
- Being tested
- temozolomide
- Keywords
- Brain Neoplasms, Temozolomide, Effectiveness, Safety, Glioma, Amitzo, Adverse Event
- Medical subject headings
- Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temozolomideDrug
Temozolomide (Amitzo®, NanoAlvand), during the first five days of every 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving temozolomide (Amitzo®, NanoAlvand) | Not described Receives: Drug: temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the incidence of hepatic injury in patients with grade III and IV glioma tumors, receiving temozolomide (Amitzo®, NanoAlvand)
Measured: 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
- 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)
Measured: 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
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start22 Mar 2026
- Primary completionSep 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NanoAlvand
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- mohadese shahin, Assistant Professor, Principal investigator, Iran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675070
- Sponsor's protocol ID
- TEM.NA.MS.IV.05
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data regarding this study will be shared, upon reasonable request from the investigator.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07675070
- Acronym / sponsor ID
- TEM.NA.MS.IV.05
- Conditions
- Brain Tumor, Grade III Glioma, Grade IV Glioma
- Keywords
- Brain Neoplasms, Temozolomide, Effectiveness, Safety, Glioma, Amitzo, Adverse Event
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- NanoAlvandIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving temozolomide (Amitzo®, NanoAlvand) | – | Drug: temozolomide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients without a baseline MRI
- Patients who are unwilling to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| temozolomideTemozolomide (Amitzo®, NanoAlvand), during the first five days of every 28-day cycle. | Drug | Patients receiving temozolomide (Amitzo®, NanoAlvand) |
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Undecided. Data regarding this study will be shared, upon reasonable request from the investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
mohadese shahin, Assistant Professor principal investigator
Iran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor and Grade III Glioma, run by NanoAlvand at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nassim Anjidani, PharmD (+982143473000 ext. 3200, anjidani.n@orchidpharmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.