Trial reportJournal of neuro-oncology2025
A phase I-II study of niacin in patients with newly diagnosed glioblastoma: safety and interim phase II analysis.
Trial report in Journal of neuro-oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04677049 (A Phase I-II Study of Niacin in Patients With Newly Diagnosed Glioblastoma Receiving Concurrent Radiotherapy and Temozolomide Followed by Monthly Temozolomide), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase I-II Study of Niacin in Patients With Newly Diagnosed Glioblastoma Receiving Concurrent Radiotherapy and Temozolomide Followed by Monthly Temozolomide
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeSurvival of patients with glioblastoma (GB) treated with standard of care (SOC) surgery, radiotherapy, and temozolomide is 15 months with progression free survival at 6 months (PFS-6 M) of 53.9%. In vivo studies showed increased survival in mice with GB treated with niacin. This is a first in human Phase I-II study aiming to evaluate safety and efficacy of controlled-release niacin (NiacinCRT ™) added to SOC.
methodsPatients 18–75 years old with newly diagnosed glioblastoma eligible for SOC treatment were included. Phase I evaluated intra-patient dose escalation of niacin (500–3000 mg/d) to determine dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended phase II dose (RP2D). Phase II aims to determine if niacin adds ≥ 20% absolute increase in PFS-6 M over historical controls. Interim/futility analysis was planned when 24 patients become evaluable for PFS-6 M. The study would stop if the conditional power (one-sided Z test) < 20% or futility index > 80%.
resultsPhase I included 15 patients; median age: 57 years (37–68), 40% women, and 47% with MGMT promoter methylated. The most common side effect was flushing (10/15; 9 grade 1). Two DLTs occurred at 2,500 mg/d niacin (grade 3 thrombocytopenia and hyperbilirubinemia). Niacin dose escalated up to 2000 mg/d is the ongoing RP2D. Interim analysis by central radiology review reported PFS-6 M of 82.3% (CI95% 82.14–82.46%).
conclusionThe MTD dose of niacin added to first line treatment in patients with GB is 2000 mg/d. The interim analysis already showed an absolute increase in PFS-6 M of 28%. TRIAL REGISTRATION NUMBER: (1) Local ethics board approval - HREBA cc 20–0402. (2) Clinicaltrials.gov - NCT04677049. Registered 15 Dec 2020.
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Registered trials
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