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NCT04915404
Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme (WHO Grade IV)
Phase 1, PHASE2 trial testing Berubicin Hydrochloride in Recurrent Glioblastoma Multiforme in 5 participants. Terminated before completion.
30 December 2023
Quick facts
| Lead sponsor | WPD Pharmaceuticals Sp. z o.o. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 5 |
| Start date | 7 December 2022 |
| Primary completion | 30 December 2023 |
| Estimated completion | 30 December 2023 |
| Sites | 2 locations across Poland |
Drugs / interventions tested
- Berubicin Hydrochloride — full drug profile →
Conditions studied
- Recurrent Glioblastoma Multiforme — all drugs for Recurrent Glioblastoma Multiforme →
Sponsor
WPD Pharmaceuticals Sp. z o.o.
Who can join
18 and older, any sex, with Recurrent Glioblastoma Multiforme. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, open-label, Phase 1b/2 efficacy and safety study of Berubicin utilizing a Simon's 2-stage design to confirm the efficacy (or futility) of a single arm of Berubicin treatment, administered at the recommended Phase 2 dose (RP2D) identified in Phase 1 studies (7.5 mg/m2 Berubicin HCl), on the endpoint of ORR in up to approximately 61 patients. A central reader will determine the radiologic responses for each patient according to m RANO criteria. The responder criteria for this Simon's design will be based on objective response criteria defined as individual patients achieving CR or PR per m-RANO criteria within 6 months from baseline.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Looking for the Holy Grail-Drug Candidates for Glioblastoma Multiforme Chemotherapy.
Pająk B. · · 2022 · cited 21× · PMID 35625738 · DOI 10.3390/biomedicines10051001 -
Investigational treatment strategies in glioblastoma: progress made and barriers to success.
Nelson TA, Dietrich J. · · 2023 · cited 11× · PMID 37796104 · DOI 10.1080/13543784.2023.2267982 -
Role of scaffold proteins in the heterogeneity of glioblastoma.
Iyer VJ, Donahue JE, Osman MA. · · 2024 · cited 2× · PMID 39375741 · DOI 10.1186/s12964-024-01809-1
Verify or expand the search:
- PubMed search for NCT04915404
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Recurrent Glioblastoma Multiforme
Currently open trials in the same condition.
- NCT03423628 — A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04915404 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by WPD Pharmaceuticals Sp. z o.o.
- Last refreshed: 6 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04915404.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing