Itraconazole (ITRA) with standard radiotherapy (RT) and temozolomide (TMZ) in patients with newly diagnosed glioblastoma multiforme (GBM) ITRA-RAD: Phase I Clinical Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Otto Von Guericke Universitaet Magdeburg

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Not possible to specify

Trial duration

7 Apr 2025 → ongoing

Decision date (initial)

2025-03-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

University Clinic of Radiotherapy Magdeburg

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Dose response, Therapy, Efficacy

To determine the maximum tolerated dose (MTD) of ITRA given concurrently with RT and TMZ.

Secondary objectives 1

1. To determine the safety profile of ITRA according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. • To determine the effect of ITRA on overall survival (OS) • To assess the tolerability of the treatment regimen to evaluate patient-reported health-related quality of life outcomes

Conditions and MedDRA coding

Glioblastom

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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

Exclusion criteria 1

1. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Determination of the maximum tolerated dose (MTD) of ITRA administered concomitantly with standard treatment (RT and TMZ)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Otto Von Guericke Universitaet Magdeburg

Sponsor organisation

Otto Von Guericke Universitaet Magdeburg

Address

Leipziger Strasse 44, Leipziger Str. Leipziger Str.

City

Magdeburg

Postcode

39120

Country

Germany

Scientific contact point

Organisation

Otto Von Guericke Universitaet Magdeburg

Contact name

Sponsor representitive

Public contact point

Organisation

Otto Von Guericke Universitaet Magdeburg

Contact name

KKS Magdeburg

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications