Itraconazole for Glioblastoma multiforme

Inclusion criteria

• {"criterion_text":"- 1.\tHistologically confirmed diagnosis of GBM"}
• {"criterion_text":"- 2.2.\tNo previuos treatment except surgery (i.e., no previous RT, local chemotherapy, or systemic therapy) is allowed. Subjects who were not candidates for surgery and had biopsy only and could be treated with standard RT (60 Gy in 30 fractions) and TMZ. Patients must be able to undergo serial MRI scans."}
• {"criterion_text":"- 3.\t ≥ 18 years old"}
• {"criterion_text":"- 4.\tAdequate renal and hepatic function and hematopoietic capacity"}
• {"criterion_text":"- 5.\tECOG performance status of ≤ 2 and must be able to swallow whole capsules"}
• {"criterion_text":"- 6.\tMust be able to understand and comply with the protocol requirements and has signed the informed consent document"}

Exclusion criteria

• {"criterion_text":"- 1.\tPrevious treatment with systemic chemotherapy or RT or any other type of investigational agent for the treatment of brain tumours"}
• {"criterion_text":"- 2.\tEvidence of acute intracranial or intratumoural haemorrhage > Grade 1 either by MRI or Computertomography scan. Subjects with resolving haemorrhage changes, punctate haemorrhage, or hemosiderin may enter the CT"}
• {"criterion_text":"- 3.\tPregnant or breastfeeding woman"}
• {"criterion_text":"- 4.\tCongestive heart failure (compensate or decompensate)"}
• {"criterion_text":"- 5.\tSerious liver disease such a cirrhosis, acute or chronic hepatitis"}
• {"criterion_text":"- 6.\tOther serious illness such as significant cardiac arrhythmias, severe respiratory failure or acute kidney failure"}
• {"criterion_text":"- 7.\tSerious gastrointestinal symptoms such as nausea, vomiting, feeling of fullness, flatulence, constipation or diarrhea, abdominal pain, irregular bowel habits (CTCAE II° or more)"}
• {"criterion_text":"- 8.\tKnown gastrointestinal motility disorders"}
• {"criterion_text":"- 9.\tOther malignant illnesses other than surgically removed non-melanoma skin cancer or carcinoma in situ of the cervix or treated early stage prostate cancer"}
• {"criterion_text":"- 10.\tPreviously diagnosed allergy or known hypersensitivity to components of ITRA or TMZ"}
• {"criterion_text":"- 11.\tCurrent treatment with ITRA"}
• {"criterion_text":"- 12.\tRegular intake of proton pump inhibitors or H2 antagonists with known intolerance to aspartame and the presence of diabetes mellitus"}
• {"criterion_text":"- 13.\tIf patients are treated with medications that are approved for use with itraconazole are contraindicated and whose intake cannot be interrupted during this study or replaced by other medications that do not interact with itraconazole"}
• {"criterion_text":"- 14.\tParticipation in a clinical trial within the last 4 weeks"}

Primary endpoints

• {"endpoint_text":"- Determination of the maximum tolerated dose (MTD) of ITRA administered concomitantly with standard treatment (RT and TMZ)","definition_or_measurement_approach":""}

Germany

Earliest CTIS Part Ii Submission Date

11-03-2025

Latest Decision Or Authorization Date

07-04-2026

Processing Time Days

392

Number Of Sites

1

Number Of Participants

15

Primary sponsor

Full Name

Otto Von Guericke Universitaet Magdeburg

Organisation Type

Educational Institution

Country Of Registered Address

Germany