Идёт набор NCT07675070

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

— Наблюдательное Brain Tumor Grade III Glioma Grade IV Glioma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: temozolomide.
Кому может быть актуально: Состояния в реестре: Brain Tumor, Grade III Glioma, Grade IV Glioma. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Иран
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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®.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

Assessment of the incidence of hepatic injury in patients with grade III and IV glioma tumors, receiving temozolomide (Amitzo®, NanoAlvand) [Срок оценки: From enrollment to the end of study at 24 weeks]

Вторичные конечные точки (2)

Safety of temozolomide (Amitzo®, NanoAlvand) through evaluation of adverse events, based on the treating physician's assessment [Срок оценки: 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 [Срок оценки: Week 24]

Критерии участия

Критерии включения

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