drugset / Trial / NCT04677049
Study of Niacin in Glioblastoma
Phase 1/2
Active not recruiting
59 enrolled
AHS Cancer Control Alberta
Tom Baker Cancer Centre · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a single institution Phase I-II study to evaluate the tolerability and Maximum Tolerated Dose (MTD) (Phase I) and efficacy (Phase II) of adding Niacin CRT™ to standard first line treatment (concurrent Radiation Therapy (RT) and Temozolomide (TMZ) following by monthly TMZ - AKA Stupp protocol) in patients with newly diagnosed glioblastoma isocitrate dehydrogenase (IDH) wild type.
Timeline
- Start
- 2021-03-18
- Primary completion
- 2027-12
- Completion
- 2027-12
Publications
- Poon CC, Hagen KM, Sarkar S, Mirzaei R, Silva C, Ueno A, de Robles P, Roldan-Urgoiti G, Yong VW. Niacin Modulates Immune Responses in a Phase I Dose-Escalation Clinical Trial of Newly Diagnosed Glioblastoma. Neurol Neuroimmunol Neuroinflamm. 2026 Mar;13(2):e200530. doi: 10.1212/NXI.0000000000200530. Epub 2026 Feb 3.
- Roldan Urgoiti G, de Robles P, Tsang RY, Willson M, Ghosh S, Faruqi M, Lim G, Loewen S, Nordal R, Cairncross G, Leckie C, Poon CC, Yong VW. A phase I-II study of niacin in patients with newly diagnosed glioblastoma: safety and interim phase II analysis. J Neurooncol. 2025 Nov 28;176(1):101. doi: 10.1007/s11060-025-05351-z.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Niacin | Small molecule | 2000 mg | — |
| Subject | Niacin | Small molecule | 2500 mg | — |