Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT04091503
Eligibility Criteria:
Inclusion Criteria:
* Informed consent signed
* 21 years or older
* Histologically confirmed the diagnosis of Grade 4 astrocytic tumour, which includes glioblastoma, giant cell glioblastoma, gliosarcoma, and glioblastoma with oligodendroglial components
* The availability of histological material for the possibility of revising histological verification
* IDH 1 Mutation and IDH2 Mutation are not taken into account when enrolling in that study
* MGMT promoter methylation MUST BE CONFIRMED
* Must have a Karnofsky performance status of ≥ 70% and the ability to use intranasal administration
* Sexually active fertile subjects (male and female) must agree to use accepted methods of contraception during the course of the study and for 3 months after the last intranasal administration of Temozolomide
* Female subjects of childbearing potential must have a negative pregnancy test at screening.
* Must be capable of understanding and complying with the protocol requirements
Exclusion Criteria:
* History of hypersensitivity to TMZ or any of its excipients
* The subject has had major surgery within 28 days prior to starting study treatment, or had non-water-tight dural closure during previous surgery, or has unhealed wounds from previous surgery
* The subject has inherited bleeding diathesis or coagulopathy with the risk of bleeding.
* The subject is pregnant or breastfeeding
* The subject suffered a stroke according to the results of the first MRI upon admission
* Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from the effects of prior chemotherapy (haematological and bone marrow suppression effects), generally at least 3 weeks from the most recent administration (6 weeks for nitrosoureas). Subjects may not have received more than 1 cycle of Irinotecan and Temozolomide as previous relapse therapy
* Subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT04091503
Study Brief:
Protocol Section:
NCT04091503