Health Trials

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

ConditionsBrain TumorGrade III GliomaGrade IV Glioma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorNanoAlvand

About this trial

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®.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients without a baseline MRI

Patients who are unwilling to participate in the study

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • temozolomide

    Drug

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Patients receiving temozolomide (Amitzo®, NanoAlvand)1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

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)

Time frame
From enrollment to the end of study at 24 weeks
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NanoAlvand

Lead sponsor

Source ClinicalTrials.gov
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