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NCT04319276
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Phase 1 trial testing Gallium maltolate (500 mg) in Glioblastoma in 26 participants. Participants enrolled and being followed up; not accepting new ones.
13 February 2025
Quick facts
| Lead sponsor | Medical College of Wisconsin |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 11 November 2022 |
| Primary completion | 13 February 2025 |
| Estimated completion | 1 March 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Gallium maltolate (500 mg) — full drug profile →
- Gallium maltolate (1,000 mg)
- Gallium maltolate (1,500 mg) — full drug profile →
- Gallium maltolate (2,000 mg) — full drug profile →
- Gallium maltolate (2,500 mg) — full drug profile →
- Gallium maltolate (recommended phase 2 dose) — full drug profile →
Conditions studied
- Glioblastoma — all drugs for Glioblastoma →
Sponsor
Medical College of Wisconsin
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 a phase 1 investigational study to assess the safety and preliminary efficacy of oral gallium maltolate (GaM) in participants with relapsed glioblastoma (GBM).
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Potent <i>in vivo</i> efficacy of oral gallium maltolate in treatment-resistant glioblastoma.
Al-Gizawiy MM, Wujek RT, Alhajala HS, Cobb JM, et al · · 2023 · cited 4× · PMID 38288102 · DOI 10.3389/fonc.2023.1278157 -
In Vivo Trafficking of the Anticancer Drug Tris(8-Quinolinolato) Gallium (III) (KP46) by Gallium-68/67 PET/SPECT Imaging.
Darwesh AMF, Imberti C, Bartnicka JJ, Al-Salemee F, et al · · 2023 · cited 4× · PMID 37894695 · DOI 10.3390/molecules28207217 -
Gallium disrupts endoplasmic reticulum iron metabolism to induce lipid metabolic reprogramming in glioblastoma cells.
Petronek MS, Stolwijk JM, Zaher A, Owusu SB, et al · · 2025 · cited 1× · PMID 40469110 · DOI 10.1016/j.isci.2025.112404 -
Regulatory networks of iron sulfur cluster biology in cancer mechanisms and therapeutic perspectives.
Yao S, Guan H, Chai J, Liu X. · · 2026 · PMID 41952995 · DOI 10.1016/j.isci.2026.115256
Verify or expand the search:
- PubMed search for NCT04319276
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04319276 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Medical College of Wisconsin
- Last refreshed: 3 November 2025
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/NCT04319276.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing