Advanced CancerUNIQUENCT06285500
Umbrella Study for Single Patient Treatments in Oncology
An observational study of Advanced Cancer and Rare Diseases, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to collect data for assessing the improvement of the overall response rate for the overall cohorts and the proportion of patients accessing precision targeted therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Rare Diseases
- What is being tested?
- Patient-specific treatments
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2024to 1 Feb 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients have advanced and rare cancer with limited treatment options.
Who may be able to join
- Patient's existing genomic information from tumor molecular profiling will be discussed in the hospital expert molecular tumor board rounds consisting of representatives from specialist genomic profiling and medical oncology departments to decide N of 1 treatment for the patient. The discussion will surround the best next therapeutic option in the patient's cancer subtype with or without clear standard of care guidelines. Therefore, specific eligibility criteria aside from individual patient's medical history is not applicable.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Amit Oza, Dr., 416 946 4450, amit.oza@uhn.ca
About this study
Official title: UNIQUE: Umbrella N-of-1 Tumor Trials - Umbrella Protocol for Oncology Single Patient Protocols
The purpose of this study is to collect data for assessing the improvement of the overall response rate for the overall cohorts and the proportion of patients accessing precision targeted therapy.
Read the detailed description
The UNIQUE umbrella protocol is an overarching framework to study precision medicine in patients with precise molecular data, who have exhausted all established treatment options and who are not eligible for any of the ongoing trials. Participants who have received/who may receive the following treatments may join the study and will be assigned to a study cohort (group):
- Group 1 - Health Canada approved/marketed drug(s) used on or off-label as per Standard of Care (SOC)
- Group 2 - Drugs accessed from Special Access Program (SAP)
- Group 3 - Non-marketed investigational agents
Under the UNIQUE framework, data from participants will be evaluated. The following data will be collected:
- Demographic data (for example: sex, race, month and year of birth)
- Medical history
- Cancer characteristics including biomarkers
- Treatment history
- response to treatment
- Conditions
- Advanced Cancer, Rare Diseases
- Being tested
- Patient-specific treatments
- Keywords
- single patient protocols
- Medical subject headings
- Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-specific treatmentsOther
Treatment will be decided specifically for the patient based on biomarker test results.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | N-of-1 treatment with marketed drugs used on or off-label as per SOC. Receives: Other: Patient-specific treatments | |
| Group 2 | N-of-1 treatment with drugs accessed from SAP. Receives: Other: Patient-specific treatments | |
| Group 3 | N-of-1 treatment with non-marketed investigational agents. Receives: Other: Patient-specific treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate for the overall cohorts and the number of patients accessing precision targeted therapy
Measured: 3 years
Secondary outcomes (3)
Overall survival rate
Measured: 5 years
Progression-free survival
Measured: 5 years
Number of participants with adverse events as assessed by CTCAE v5.0
For Groups 1 and 2: Only Grade 3 and above AEs/AESIs and SAEs that are related (possibly, probably or definitely) to the study drug.
For Group 3: All SAEs (regardless of causality).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Feb 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Oza, Dr., Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285500
- Sponsor's protocol ID
- UNIQUE
- Other IDs
- 23-5095
- Acronym
- UNIQUE
- Status last verified
- Dec 2025
- First submitted
- 7 Feb 2024
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UNIQUE: Umbrella N-of-1 Tumor Trials - Umbrella Protocol for Oncology Single Patient Protocols
- ClinicalTrials.gov ID
- NCT06285500
- Acronym / sponsor ID
- UNIQUE / UNIQUE
- Conditions
- Advanced Cancer, Rare Diseases
- Keywords
- single patient protocols
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 29 Feb 2024 (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.
The purpose of this study is to collect data for assessing the improvement of the overall response rate for the overall cohorts and the proportion of patients accessing precision targeted therapy.
Detailed description
The UNIQUE umbrella protocol is an overarching framework to study precision medicine in patients with precise molecular data, who have exhausted all established treatment options and who are not eligible for any of the ongoing trials. Participants who have received/who may receive the following treatments may join the study and will be assigned to a study cohort (group):
- Group 1 - Health Canada approved/marketed drug(s) used on or off-label as per Standard of Care (SOC)
- Group 2 - Drugs accessed from Special Access Program (SAP)
- Group 3 - Non-marketed investigational agents
Under the UNIQUE framework, data from participants will be evaluated. The following data will be collected:
- Demographic data (for example: sex, race, month and year of birth)
- Medical history
- Cancer characteristics including biomarkers
- Treatment history
- response to treatment
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Patient-specific treatmentsN-of-1 treatment with marketed drugs used on or off-label as per SOC. |
| Group 2 | – | Other: Patient-specific treatmentsN-of-1 treatment with drugs accessed from SAP. |
| Group 3 | – | Other: Patient-specific treatmentsN-of-1 treatment with non-marketed investigational agents. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients have advanced and rare cancer with limited treatment options.
Key inclusion criteria (1 listed)
- Patient's existing genomic information from tumor molecular profiling will be discussed in the hospital expert molecular tumor board rounds consisting of representatives from specialist genomic profiling and medical oncology departments to decide N of 1 treatment for the patient. The discussion will surround the best next therapeutic option in the patient's cancer subtype with or without clear standard of care guidelines. Therefore, specific eligibility criteria aside from individual patient's medical history is not applicable.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Patient-specific treatmentsTreatment will be decided specifically for the patient based on biomarker test results. | Other | Group 1, Group 2, Group 3 |
Primary outcome
Overall response rate for the overall cohorts and the number of patients accessing precision targeted therapy
Time frame: 3 years
3 secondary outcomes
Overall survival rate
Time frame: 5 years
Progression-free survival
Time frame: 5 years
Number of participants with adverse events as assessed by CTCAE v5.0
Time frame: 3 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 16 Dec 2025.
- 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.
Amit Oza, Dr. principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancer and Rare Diseases, run by University Health Network, Toronto 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 1 inclusion and 0 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 16 Dec 2025. 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.
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 Amit Oza, Dr. (416 946 4450, amit.oza@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate for the overall cohorts and the number of patients accessing precision targeted therapy (time frame: 3 years). 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 16 Dec 2025.