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NCT04629209
A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma
Phase 2 trial testing ONC201 in Glioblastoma. Withdrawn.
31 December 2024
Quick facts
| Lead sponsor | Masonic Cancer Center, University of Minnesota |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 28 June 2024 |
| Primary completion | 31 December 2024 |
| Estimated completion | 30 June 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- ONC201 — full drug profile →
Conditions studied
- Glioblastoma — all drugs for Glioblastoma →
Sponsor
Masonic Cancer Center, University of Minnesota
Who can join
18 and older, any sex, with Glioblastoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label, two arm study. The trial will enroll a total of up to 36 patients. Arm A will enroll up to a total of 6 evaluable patients and Arm B will enroll up to a total of 30 evaluable patients. Arm A will explore the intra-tumoral ONC201 concentrations and pharmacodynamic activity in adult EGFR-low glioblastoma patients. Arm B will determine the radiographic efficacy of ONC201 in adult recurrent EGFR-low glioblastoma patients. All patients will be treated with oral ONC201 (625 mg) twice weekly, 2 consecutive days on and 5 days off per week schedule.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Mechanisms of imipridones in targeting mitochondrial metabolism in cancer cells.
Bonner ER, Waszak SM, Grotzer MA, Mueller S, et al · · 2021 · cited 50× · PMID 33336683 · DOI 10.1093/neuonc/noaa283 -
Metabolic Rewiring in Glioblastoma Cancer: <i>EGFR</i>, <i>IDH</i> and Beyond.
El Khayari A, Bouchmaa N, Taib B, Wei Z, et al · · 2022 · cited 43× · PMID 35912242 · DOI 10.3389/fonc.2022.901951 -
A review of current therapeutics targeting the mitochondrial protease ClpP in diffuse midline glioma, H3 K27-altered.
Jackson ER, Persson ML, Fish CJ, Findlay IJ, et al · · 2024 · cited 30× · PMID 37589388 · DOI 10.1093/neuonc/noad144 -
Hijacking of the nervous system in cancer: mechanism and therapeutic targets.
Zhang Y, Liao Q, Wen X, Fan J, et al · · 2025 · cited 20× · PMID 39915765 · DOI 10.1186/s12943-025-02246-5 -
Imipridones and Dopamine Receptor Antagonism in the Therapeutic Management of Gliomas.
Burton E, Ozer BH, Boris L, Brown D, et al · · 2024 · cited 3× · PMID 38868646 · DOI 10.1016/j.yao.2024.02.003 -
Targeting the Mitochondria in High-Grade Gliomas.
Sathe S, Li Q, Jung J, Wu J. · · 2025 · cited 2× · PMID 41008904 · DOI 10.3390/cancers17183062 -
The GPCR Connection: Linking Alzheimer's Disease and Glioblastoma.
Caniceiro AB, Agostinho SP, Piochi LF, Rosário-Ferreira N, et al · · 2026 · PMID 41958080 · DOI 10.1111/jcmm.71131
Verify or expand the search:
- PubMed search for NCT04629209
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials testing the same drug.
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- NCT03394027 — ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma · Phase 2 · completed
- NCT03034200 — Phase 2 Study of ONC201 in Neuroendocrine Tumors · Phase 2 · completed
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Currently open trials in the same condition.
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Other Masonic Cancer Center, University of Minnesota trials
Trials by the same sponsor.
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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 NCT04629209 (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 Masonic Cancer Center, University of Minnesota
- Last refreshed: 24 November 2023
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/NCT04629209.
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