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Brain tumor drug safety under scrutiny: temozolomide liver risk study launched

NCT ID NCT07675070

Disease control Sponsor: NanoAlvand Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study looks at how safe and effective temozolomide (brand name Amitzo) is for people with aggressive brain tumors (grade III and IV gliomas). Researchers are tracking 100 patients to see how often liver injury occurs and to monitor other side effects. The goal is to better understand the risks of this chemotherapy drug in real-world use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
temozolomide (Amitzo)
What this could lead to
If successful, this study could confirm the safety profile of temozolomide for glioma patients, potentially guiding safer treatment protocols.
What could go wrong
This is an observational study with no control group, so results may not prove cause and effect. Liver injury is a known risk of temozolomide, and the study's small size limits general conclusions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

brain cancer brain neoplasm glioblastoma glioma grade III glioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain tumor Grade III glioma Grade IV glioma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Orchid Pharmed

    RECRUITING

    Tehran, Iran

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