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Itraconazole (ITRA) with standard radiotherapy (RT) and temozolomide (TMZ) in patients with newly diagnosed glioblastoma multiforme (GBM) ITRA-RAD: Phase I Clinical Study
EU CTIS ID: 2024-519239-40-01
What this study is testing
To determine the maximum tolerated dose (MTD) of ITRA given concurrently with RT and TMZ.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Histologically confirmed diagnosis of GBM 2.2. No 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. 3. ≥ 18 years old 4. Adequate renal and hepatic function and hematopoietic capacity 5. ECOG performance status of ≤ 2 and must be able to swallow whole capsules 6. Must be able to understand and comply with the protocol requirements and has signed the informed consent document
You likely can't join if
- 1. Previous treatment with systemic chemotherapy or RT or any other type of investigational agent for the treatment of brain tumours 2. Evidence 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 3. Pregnant or breastfeeding woman 4. Congestive heart failure (compensate or decompensate) 5. Serious liver disease such a cirrhosis, acute or chronic hepatitis 6. Other serious illness such as significant cardiac arrhythmias, severe respiratory failure or acute kidney failure 7. Serious gastrointestinal symptoms such as nausea, vomiting, feeling of fullness, flatulence, constipation or diarrhea, abdominal pain, irregular bowel habits (CTCAE II° or more) 8. Known gastrointestinal motility disorders 9. Other malignant illnesses other than surgically removed non-melanoma skin cancer or carcinoma in situ of the cervix or treated early stage prostate cancer 10. Previously diagnosed allergy or known hypersensitivity to components of ITRA or TMZ 11. Current treatment with ITRA 12. Regular intake of proton pump inhibitors or H2 antagonists with known intolerance to aspartame and the presence of diabetes mellitus 13. If 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 14. Participation in a clinical trial within the last 4 weeks
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.