A Phase 1/2 interventional study of Niacin CRT in Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, sponsored by AHS Cancer Control Alberta. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by AHS Cancer Control Alberta · Phase 1/2, Interventional, and Treatment
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.
During the Phase I stage Niacin CRT™ dose will be escalated every 4 weeks until the maximum tolerated dose (MTD) is determined. The MTD dose will be prescribed to patients during the Phase II stage.
During the Phase I study a sample of blood at baseline, at each level dose of Niacin CRT™, and every two months during the maintenance phase while on Niacin CRTTM will be sent to a lab to evaluate the peripheral activity of Niacin CRT™ in innate immune system cells. These samples will be taken at the time of routine standard of care lab work.
Based on prior clinical trials evaluating niacin extended release formulation for the management of dyslipidaemias there is vast experience on dose escalation of niacin. One of the main side effects is flushing that is ameliorated by escalating doses in intervals no shorter than 4 weeks and usually decreases with time.
Following this schema, there is no increase in dose coinciding with TMZ while administered in a 5/28 days schedule (given daily for 5 days of each 28-day cycle). This will not only improve tolerance but also will allow us to differentiate potential adverse events from chemotherapy from the ones from Niacin CRT™.
1,921 studies on the registry are indexed under Glioblastoma; 451 are open to participants now.
This study's planned enrollment of 59 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →AHS Cancer Control Alberta is the lead sponsor of 182 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Niacin controlled release technology (CRT): Niacin CRT™ is to be started 7 days before concurrent Radiation Therapy (RT)- Temozolomide (TMZ) treatment. Chemo/Radiation Therapy: For all patients, regardless of the phase of the study, concurrent RT and TMZ for 6 weeks followed by 6-12 cycles of monthly TMZ will be given. Concurrent Temozolomide: TMZ will be administered from the first to the last day of RT at 75 mg/m2 orally (PO) for a maximum of 49 days. Monthly Temozolomide: Cycles of chemotherapy Day 1 to Day 5 every 28 days will start 28 days (+/- 2 days) after the end of RT-TMZ. First cycle of TMZ is administered at 150 mg/m2 Day 1-Day 5 by mouth (PO) and increased to 200 mg/m2 Day 1-Day 5 PO from cycle 2 onwards if well tolerated. While 6 cycles are standard of care, the Neuro-Oncologist may continue up to 12 cycles if clinically appropriate.
Drug: Niacin CRT
A controlled release technology (CRT) tablet of Niacin
Also known as: Nicotinic acid, Vitamin B3
Determining the Maximum Tolerated Dose
To evaluate and determine maximum tolerated dose (MTD) of Niacin CRT added to concurrent radiotherapy (RT) and temozolomide (TMZ) in patients with newly diagnosed glioblastoma (GB).
Time frame: Up to 24 weeks after registration onto the study
Evaluating if Niacin CRT Improves Glioblastoma Survival Rates
To evaluate if adding Niacin CRT to current standard first line treatment of GB improves progression free survival (PFS) at 6 months.
Time frame: 6 months after determining the maximum tolerated dose which can last up to 24 weeks after registration onto the study
Effect of Niacin CRT in Peripheral Monocytes
To evaluate the effect of Niacin CRT in peripheral monocytes by comparing control monocytoid cells to those that have been treated with Niacin.
Time frame: From date of registration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 5 years.
Response Rate Associated with Niacin
To determine the response rate associated with the investigational regimen.
Time frame: From date of registration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 5 years.
Overall Survival Rate Associated with Niacin
To determine the overall survival (OS) associated with the investigational regimen.
Time frame: From date of registration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 5 years.
Quality of Life While on Study using EORTC QLQ-C30 Questionnaires
To determine Quality of Life (QOL) that will be evaluated throughout the study using EORTC QLQ-C30 questionnaires.
Time frame: From date of registration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 5 years.
Quality of Life While on Study using EORTC BN-20 Questionnaires
To determine Quality of Life (QOL) that will be evaluated throughout the study using EORTC BN-20 questionnaires.
Time frame: From date of registration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 5 years.
Plan to share: No
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AHS Cancer Control Alberta