Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
175
Countries
1
Sites
2
Glioblastoma multiforme
An open label, Phase IV study to assess immunological changes in patients with glioblastoma multiforme treated with bevacizumab infusion
Key facts
- Sponsor
- Orszagos Onkologiai Intezet
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2024-06-28
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- National Institute of Oncology
External identifiers
- EU CT number
- 2024-512136-30-00
- EudraCT number
- 2022-002700-21
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
An open label, Phase IV study to assess immunological changes in patients with glioblastoma multiforme treated with bevacizumab infusion
Secondary objectives 1
- Overall survival
Conditions and MedDRA coding
Glioblastoma multiforme
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Not recurrent glioblastoma multiforme patients (either after opus or with no opus) before radiotherapy and temozolomide therapy. Recurrent patients who have already undergone other therapeutic intervention (surgery, radiotherapy and temozolomide therapy) and due to the recurrence of the disease, based on clinical experience, it is justified to start bevacizumab therapy. Known relapse patients who are already receiving bevacizumab therapy.
Exclusion criteria 1
- Unwillingness to sign the written Informed Consent Form. History of psychiatric diseases and treatment. Hypersensitivity to the active substance or to any of the excipients. Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies. Participation in another clinical trial within 3 months prior to this study. Known drug or chronic alcohol abuse, drug addiction. Malignant disease other than GBM. Legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study. Evidence of an uncooperative attitude. Vulnerable subject.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1. Immunological changes in patients during the course of the disease before and under bevacizumab treatment, which might predict the course of the disease. 2. Local relapse free survival 3. Progression free survival 4. Overall survival.
Secondary endpoints 1
- Investigation of plasma-derived extracellular vesicles (EV), their micro-RNA and protein content, and free DNA-RNA fragments. We do not perform genome sequencing.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB16402MIG · Substance
- Active substance
- Bevacizumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 10 mg/Kg milligram(s)/kilogram
- Max total dose
- 110 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 2
SUB16402MIG · Substance
- Active substance
- Bevacizumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 10 mg/kg milligram(s)/kilogram
- Max total dose
- 110 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Avastin 25 mg/ml concentrate for solution for infusion.
PRD2153902 · Product
- Active substance
- Bevacizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 10 mg/kg milligram(s)/kilogram
- Max total dose
- 110 mg/kg milligram(s)/kilogram
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FG01 — -
- Marketing authorisation
- EU/1/04/300/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Orszagos Onkologiai Intezet
2
Total trials
Academic / Non-commercial
- Sponsor organisation
- Orszagos Onkologiai Intezet
- Address
- Rath Gyorgy Utca 7-9, Kerulet Kerulet
- City
- Budapest XII
- Postcode
- 1122
- Country
- Hungary
Scientific contact point
- Organisation
- Orszagos Onkologiai Intezet
- Contact name
- Orszagos Onkologiai Intezet
Public contact point
- Organisation
- Orszagos Onkologiai Intezet
- Contact name
- Orszagos Onkologiai Intezet
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Authorised, recruitment pending | 175 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Orszagos Onkologiai Intezet
Dept. of Radiobiology and Diagnostic Oncocytogenetics, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
University Of Szeged
Oncology Clinic, Koranyi Fasor 12, 6720, Szeged
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Bevacizumab study protocol modified 20240306 | 1 |
| Recruitment arrangements (for publication) | Recruitmentprocedure_en | 1 |
| Subject information and informed consent form (for publication) | Glioblastoma tajekoztato es beleegyezo nyilatkozat OOI | 1 |
| Subject information and informed consent form (for publication) | Glioblastoma tajekoztato es beleegyezo nyilatkozat Szeged | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | avastin-epar-product-information_en | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-20 | Hungary | Acceptable 2024-06-27
|
2024-06-28 |