2024-515952-19-00RecruitingPhase 2
Study of the effectiveness of drugs selected depending on the molecular profile of diffuse intrinsic pontine glioma (DIPG).
Multicenter, open label study using molecularly determined targeted therapies in children 3-18 years of age with DIPG (diffuse intrinsic pontine glioma- DIPG)- DIPGen
Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The aim of the study is to develop the optimal treatment for patients with DIPG by identifying molecular markers important for therapy, adjusting the type of medicinal product to the indicated markers and assessing the safety and efficacy of selected drugs (sirolimus, trametinib) in the treatment of DIPG in children
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 16 Oct 2024
- Start date
- 18 Dec 2024
- Lead sponsor
- Instytut Pomnik Centrum Zdrowia Dziecka
- Diseases
- Childhood cancers
- EU CT number
- 2024-515952-19-00
- EudraCT number
- 2021-001375-16
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous (< 5 yrs ) diagnosis of malignant neoplasm
- Concomitant use of CYP3A or PgP inhibitors
- Major surgery in the past 28 days
Other illness
- Any severe comorbid disease (eg kidney insufficiency, immunological deficiencies, HIV infection)
- Clinically significant cardiovascular condition ( eg arrythmia)
- Active infection requiring systemic treatment
- Known allergy to the studied products
- Radiological evidence of active intracranial hemorrhage (excluding receding post biopsy or focal bleeding)
Who the study is looking for
- Age 3 to 18 years, inclusive
- Informed consent signed by parents or legal guardian of minor and by patient over 13 years of age) for the study diagnostic and therapeutic procedures, including molecular -based diagnostic and prognostic tests using NGS method
- Diagnosis of diffuse intrinsic pontine glioma (DIPG) based on clinical and radiological criteria
- Histological diagnosis of glioma WHO grade III and IV confirmed by reference pathologist
Age in the registry: - to 64 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Górnośląskie Centrum Zdrowia Dziecka | Katowice | Poland | Recruiting |
| Instytut Pomnik Centrum Zdrowia Dziecka | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.