Childhood CancerPhase 1/2CAN-PONCNCT05754840
CANnabinoids in Pediatric ONCology
A Phase 1/2 study testing MPL-001, MPL-005 and MPL-009 in people with Childhood Cancer and Cancer, run by University of Manitoba at 3 sites in Canada.
Trial summary
CANnabinoids in Pediatric ONCology is a randomized, double blind, adaptive clinical trial looking at the tolerability of cannabinoids in children with cancer across 3 Canadian children's hospitals. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Childhood Cancer, Cancer
- What is being tested?
- MPL-001, MPL-005 and MPL-009
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesCanada
- Study dates
- 18 Jul 2025to 31 Dec 2026
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 4-17 years old at the time of enrollment
- Diagnosed with relapsed or refractory solid or hematologic malignancy including brain tumours
- Currently receiving active cancer treatment or supportive and palliative care
- Estimated survival of at least 4 months at the time of enrollment
Who cannot join
- History of cardiovascular disease, severe hepatic or renal impairment defined by alanine transaminase (ALT)/ aspartate aminotransferase (AST) more than 5x upper limit of normal (ULN), creatinine more than 5x ULN or glomerular filtration rate (GFR less than) <60 mL/min/1.73 m273m2, unstable/unmanaged arrhythmias, uncontrolled hypertension with blood pressure above 99th centile for age or history of myocardial infarction
- Nabilone or other cannabis-based products use (including for recreational purposes) within the past 2 weeks or planned nabilone use for the duration of their enrollment in the trial. Current use/continued use of recreational cannabis, or not willing to abstain from recreational cannabis use during the trial
- Anyone who is pregnant or breast/chest-feeding throughout the duration of the study or has the intention to become pregnant within 3 months of study completion
- Participation in other clinical trials that prohibit the concurrent use of cannabis
- Children with a personal or family history of schizophrenia or psychotic disorders, substance use disorder or allergy to cannabinoids or cannabis
- Unwilling or unable to use effective form of contraception and refrain from driving motorized vehicles (cars, motorcycles, boats, etc.) throughout the study period
- Anyone who is currently receiving cell therapies or immune checkpoint inhibitors
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Bruce Crooks, MD, 9024706404, bruce.crooks@iwk.nshealth.ca
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Adam Rapoport, MD, FRCPC, MHSc, 4162761076, adam.rapoport@sickkids.ca
- Recruiting
BC Children's Hospital
Vancouver, British Columbia, V6H 3N1
Rod Rassekh, MD, FRCPC, 6048752406, rrassekh@cw.bc.ca
About this study
Official title: A Randomized, Double-Blind Tolerability Trial of Cannabinoids for Symptom Management in Children With Cancer: the CAN-PONC Trial
CANnabinoids in Pediatric ONCology is a randomized, double blind, adaptive clinical trial looking at the tolerability of cannabinoids in children with cancer across 3 Canadian children's hospitals.
Read the detailed description
This is a multi-centered, pragmatic, double-blind, adaptive, dose-escalation study to establish the tolerability of Cannabis Herbal Extracts (CHE) containing different ratios of delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD). Study arms will contain the following ratios THC:CBD 1:25 (arm 1), 1:5 (arm 2) and 1:1 (arm 3). CAN-PONC will enroll 20 participants recruited into each arm, for a total of 60 study participants.
To inform the dose for the arm containing the most THC, this study will take place in two stages. In Stage One: The first 20 participants will be randomized 1:1 into arm 1 and arm 2. Once 20 participants have been recruited, trial recruitment will halt until the last participant reaches the maintenance phase, the maximum THC dose at which less than 30% of participants reported dose limiting toxicities (Max-D30) has been established, the remaining 40 recruited participants will be randomized 1:1:2 into arm 1, arm 2 and arm 3 in Stage Two of this study.
All arms consist of three phases: baseline phase (no interventional product for two weeks), treatment phase (dose escalations for eight weeks), and a maintenance phase (maximum tolerated dose for four weeks).
- Conditions
- Childhood Cancer, Cancer
- Being tested
- MPL-001, MPL-005, MPL-009
- Keywords
- cannabinoids, CBD, THC, pediatrics, cannabis
- Medical subject headings
- Neoplasms, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPL-001Drug
High-CBD arm (MPL-001) a cannabidiol-enriched cannabis herbal extract which contains a 1:25 ratio of THC:CBD. The MPL-001 oil is produced by MediPharm Labs, each ml contains 50mg CBD and 2mg THC.
MPL-005Drug
Medium-CBD arm (MPL-005) a cannabidiol-enriched cannabis herbal extract which contains a 1:5 ratio of THC:CBD. The MPL-005 oil is produced by MediPharm Labs, each ml contains 25mg CBD and 5mg THC.
MPL-009Drug
Balanced arm (MPL-009) a balanced 1:1 ratio of THC:CBD. The MPL-009 oil is produced by MediPharm Labs, each ml contains 25mg CBD and 25mg THC.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1. High-CBD arm (MPL-001) | Experimental | High-CBD arm (MPL-001) a cannabidiol-enriched cannabis herbal extract which contains a 1:25 ratio of THC:CBD. Receives: Drug: MPL-001 |
| Arm 2. Medium-CBD arm (MPL-005) | Experimental | Medium-CBD arm (MPL-005) a cannabidiol-enriched cannabis herbal extract which contains a 1:5 ratio of THC:CBD. Receives: Drug: MPL-005 |
| Arm 3. Balanced arm (MPL-009) | Experimental | Balanced arm (MPL-009) a balanced 1:1 ratio of THC:CBD. Receives: Drug: MPL-009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (Tolerability)
Reported through study completion
Measured: 14 weeks
Secondary outcomes (4)
Pain intensity
Pain will be measured using Faces Pain Scale-Revised reported by the participants daily throughout the study. Pain will be reported for each study visit as a percentage change from the weekly average documented at baseline.
Measured: daily for 14 weeks
Symptom burden
Symptom burden is measured using the score of Symptom Screening in Pediatrics Tool (SSPedi) assessed three times a week throughout the study and will be reported as a weekly average and percentage change from baseline.
Measured: 3 times per week for 14 weeks
Quality of life (child)
Pediatric quality of life inventory (PedsQLTM) will be assessed weekly throughout the study
Measured: once per week for 14 weeks
Sleep (hours per night)
Sleep, will be reported as the number of hours per night, measured using Actigraphy and/or parent report, will be reported as an average over a one-week time period.
Measured: daily for 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start18 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Lauren Kelly, University of Manitoba
- Investigators
- Rod Rassekh, MD, Principal investigator, University of British ColumbiaBruce Crooks, MD, Principal investigator, Dalhousie UniversityAdam Rappoport, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754840
- Sponsor's protocol ID
- CAN-PONC
- Acronym
- CAN-PONC
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No. Summary level data may be available from the CAN-PONC steering committee following research ethics board approval.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Tolerability Trial of Cannabinoids for Symptom Management in Children With Cancer: the CAN-PONC Trial
- ClinicalTrials.gov ID
- NCT05754840
- Acronym / sponsor ID
- CAN-PONC / CAN-PONC
- Conditions
- Childhood Cancer, Cancer
- Keywords
- cannabinoids, CBD, THC, pediatrics, cannabis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR)
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Mar 2023 (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.
CANnabinoids in Pediatric ONCology is a randomized, double blind, adaptive clinical trial looking at the tolerability of cannabinoids in children with cancer across 3 Canadian children's hospitals.
Detailed description
This is a multi-centered, pragmatic, double-blind, adaptive, dose-escalation study to establish the tolerability of Cannabis Herbal Extracts (CHE) containing different ratios of delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD). Study arms will contain the following ratios THC:CBD 1:25 (arm 1), 1:5 (arm 2) and 1:1 (arm 3). CAN-PONC will enroll 20 participants recruited into each arm, for a total of 60 study participants.
To inform the dose for the arm containing the most THC, this study will take place in two stages. In Stage One: The first 20 participants will be randomized 1:1 into arm 1 and arm 2. Once 20 participants have been recruited, trial recruitment will halt until the last participant reaches the maintenance phase, the maximum THC dose at which less than 30% of participants reported dose limiting toxicities (Max-D30) has been established, the remaining 40 recruited participants will be randomized 1:1:2 into arm 1, arm 2 and arm 3 in Stage Two of this study.
All arms consist of three phases: baseline phase (no interventional product for two weeks), treatment phase (dose escalations for eight weeks), and a maintenance phase (maximum tolerated dose for four weeks).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1. High-CBD arm (MPL-001) | Experimental | Drug: MPL-001High-CBD arm (MPL-001) a cannabidiol-enriched cannabis herbal extract which contains a 1:25 ratio of THC:CBD. |
| Arm 2. Medium-CBD arm (MPL-005) | Experimental | Drug: MPL-005Medium-CBD arm (MPL-005) a cannabidiol-enriched cannabis herbal extract which contains a 1:5 ratio of THC:CBD. |
| Arm 3. Balanced arm (MPL-009) | Experimental | Drug: MPL-009Balanced arm (MPL-009) a balanced 1:1 ratio of THC:CBD. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Ages 4-17 years old at the time of enrollment
- Diagnosed with relapsed or refractory solid or hematologic malignancy including brain tumours
- Currently receiving active cancer treatment or supportive and palliative care
- Estimated survival of at least 4 months at the time of enrollment
Key exclusion criteria (7 listed)
- History of cardiovascular disease, severe hepatic or renal impairment defined by alanine transaminase (ALT)/ aspartate aminotransferase (AST) more than 5x upper limit of normal (ULN), creatinine more than 5x ULN or glomerular filtration rate (GFR less than) <60 mL/min/1.73 m273m2, unstable/unmanaged arrhythmias, uncontrolled hypertension with blood pressure above 99th centile for age or history of myocardial infarction
- Nabilone or other cannabis-based products use (including for recreational purposes) within the past 2 weeks or planned nabilone use for the duration of their enrollment in the trial. Current use/continued use of recreational cannabis, or not willing to abstain from recreational cannabis use during the trial
- Anyone who is pregnant or breast/chest-feeding throughout the duration of the study or has the intention to become pregnant within 3 months of study completion
- Participation in other clinical trials that prohibit the concurrent use of cannabis
- Children with a personal or family history of schizophrenia or psychotic disorders, substance use disorder or allergy to cannabinoids or cannabis
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 |
|---|---|---|
| MPL-001High-CBD arm (MPL-001) a cannabidiol-enriched cannabis herbal extract which contains a 1:25 ratio of THC:CBD. The MPL-001 oil is produced by MediPharm Labs, each ml contains 50mg CBD and 2mg THC. | Drug | Arm 1. High-CBD arm (MPL-001) |
| MPL-005Medium-CBD arm (MPL-005) a cannabidiol-enriched cannabis herbal extract which contains a 1:5 ratio of THC:CBD. The MPL-005 oil is produced by MediPharm Labs, each ml contains 25mg CBD and 5mg THC. | Drug | Arm 2. Medium-CBD arm (MPL-005) |
| MPL-009Balanced arm (MPL-009) a balanced 1:1 ratio of THC:CBD. The MPL-009 oil is produced by MediPharm Labs, each ml contains 25mg CBD and 25mg THC. | Drug | Arm 3. Balanced arm (MPL-009) |
Primary outcome
Incidence of adverse events (Tolerability)
Time frame: 14 weeks
Reported through study completion
4 secondary outcomes
Pain intensity
Time frame: daily for 14 weeks
Symptom burden
Time frame: 3 times per week for 14 weeks
Quality of life (child)
Time frame: once per week for 14 weeks
Sleep (hours per night)
Time frame: daily for 14 weeks
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 11 Jun 2026.
- Individual participant dataSharing planned: Undecided. No. Summary level data may be available from the CAN-PONC steering committee following research ethics board approval.
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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.
Rod Rassekh, MD principal investigator
University of British Columbia
Bruce Crooks, MD principal investigator
Dalhousie University
Adam Rappoport, MD principal investigator
The Hospital for Sick Children
3 sites 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 MPL-001, MPL-005 and MPL-009 in people with Childhood Cancer and Cancer, run by University of Manitoba at 3 sites 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Contact Lauren Kelly, PhD (204-242-3179, lauren.kelly@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (Tolerability) (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2026.