Glioblastoma IDH (Isocitrate Dehydrogenase) WildtypePhase 1/2NCT04677049
Study of Niacin in Glioblastoma
A Phase 1/2 study testing Niacin CRT in people with Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
- What is being tested?
- Niacin CRT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteCanada
- Study dates
- 18 Mar 2021to Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, 18 years old to 75 years old inclusive.
- New diagnoses of glioblastoma IDH wild type.
- ECOG 0-2 (Appendix I).
- Candidates for concurrent standard first line treatment according to their Neuro-Oncologist and Radiotherapy Oncologist after maximal safe debulking neurosurgery. Patients that only had biopsy are included as long as pathology confirms the diagnoses and it is considered the maximal safe procedure for that patient.
- Adequate hematological, renal and hepatic function (see details in Section 4.1 of the protocol).
- Absence of known human immunodeficiency virus (HIV) infection, chronic hepatitis B or hepatitis C infection.
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- Absence of any other serious medical condition according to the medical judgment of the Qualified Investigator prior to registration.
- Absence of any medical condition, which could interfere with oral medication intake.
- Signed informed consent.
- Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre.
- Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.
Who cannot join
- Glioblastoma, IDH-mutant.
- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years. Additionally, any low grade or low risk malignancy not requiring treatment will not exclude a patient from participation in the trial.
- Known hypersensitivity to niacin.
- Inability to provide informed consent.
- Active liver disease or unexplained persistent elevations of serum transaminases.
- Active peptic ulcer or active gastrointestinal bleeding.
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- Unstable angina or myocardial infarction within 6 months.
- Symptomatic gout.
- Patients on 3-hydroxy-3-methylglutaryl-coenzyme (HMG-COA reductase) inhibitors that cannot discontinue them at least 2 weeks before starting Niacin CRT™.
- Any prior systemic treatment for glioblastoma (standard, evidence based or experimental) or radiotherapy/radiosurgery.
- Individuals with MRI non-compatible metal in the body, or unable to undergo MRI procedures including allergy to gadolinium.
- Patients unfit for any treatment component, including contraindications for radiotherapy or Connective Tissue Disease.
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Has known psychiatric or substance abuse disorders that would interfere with compliance with the requirements of the trial.
- Pregnant, breast-feeding, unable and/or unwilling to use contraception methods.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Tom Baker Cancer Centre/Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
About this study
Official title: A Phase I-II Study of Niacin in Patients With Newly Diagnosed Glioblastoma Receiving Concurrent Radiotherapy and Temozolomide Followed by Monthly Temozolomide
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.
Read the detailed description
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™.
- Being tested
- Niacin CRT
- Keywords
- Glioblastoma
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niacin CRTDrug
Also called Nicotinic acid, Vitamin B3
A controlled release technology (CRT) tablet of Niacin
| Study group | Role | What they receive |
|---|---|---|
| Niacin | Experimental | 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. Receives: Drug: Niacin CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 6 months after determining the maximum tolerated dose which can last up to 24 weeks after registration onto the study
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start18 Mar 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma IDH (Isocitrate Dehydrogenase) WildtypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Tom Baker Cancer Centre
- Responsible party
- Sponsor
- Investigators
- Gloria Roldan Urgoiti, MD, Principal investigator, Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677049
- Sponsor's protocol ID
- NiacinCNS2020
- Status last verified
- Sep 2026
- First submitted
- 3 Dec 2020
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41632924Roldan 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.
PubMed 41313494
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II Study of Niacin in Patients With Newly Diagnosed Glioblastoma Receiving Concurrent Radiotherapy and Temozolomide Followed by Monthly Temozolomide
- ClinicalTrials.gov ID
- NCT04677049
- Acronym / sponsor ID
- NiacinCNS2020
- Keywords
- Glioblastoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Tom Baker Cancer Centre
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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™.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Niacin | Experimental | Drug: Niacin CRTNiacin 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults, 18 years old to 75 years old inclusive.
- New diagnoses of glioblastoma IDH wild type.
- ECOG 0-2 (Appendix I).
- Candidates for concurrent standard first line treatment according to their Neuro-Oncologist and Radiotherapy Oncologist after maximal safe debulking neurosurgery. Patients that only had biopsy are included as long as pathology confirms the diagnoses and it is considered the maximal safe procedure for that patient.
- Adequate hematological, renal and hepatic function (see details in Section 4.1 of the protocol).
Key exclusion criteria (15 listed)
- Glioblastoma, IDH-mutant.
- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years. Additionally, any low grade or low risk malignancy not requiring treatment will not exclude a patient from participation in the trial.
- Known hypersensitivity to niacin.
- Inability to provide informed consent.
- Active liver disease or unexplained persistent elevations of serum transaminases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niacin CRTAlso: Nicotinic acid, Vitamin B3A controlled release technology (CRT) tablet of Niacin | Drug | Niacin |
Primary outcome
Determining the Maximum Tolerated Dose
Time frame: Up to 24 weeks after registration onto the study
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).
Evaluating if Niacin CRT Improves Glioblastoma Survival Rates
Time frame: 6 months after determining the maximum tolerated dose which can last up to 24 weeks after registration onto the study
To evaluate if adding Niacin CRT to current standard first line treatment of GB improves progression free survival (PFS) at 6 months.
5 secondary outcomes
Effect of Niacin CRT in Peripheral Monocytes
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
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
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Derived from this study: PubMed 41632924Poon 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.
- Derived from this study: PubMed 41313494Roldan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gloria Roldan Urgoiti, MD principal investigator
Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Niacin CRT in people with Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, run by AHS Cancer Control Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining the Maximum Tolerated Dose (time frame: Up to 24 weeks after registration onto the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04677049, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.