Umbrella Study for Single Patient Treatments in Oncology | NCT06285500

Studies
Umbrella Study for Single Patient Treatments in Oncology

NCT06285500

Sponsor

University Health Network, Toronto

Status

Recruiting

Last Update Posted

Dec 16, 2025Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Advanced Cancer
Rare Diseases

Interventions

Patient-specific treatments

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
23-5095	Other Identifier	University Health Network

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2024Actual

Primary Completion Date

Feb 1, 2027Estimated

Completion Date

Feb 1, 2029Estimated

First Submitted Date

Feb 7, 2024

First Submission Date that Met QC Criteria

Feb 22, 2024

First Posted Date

Feb 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2025

Last Update Posted Date

Dec 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Group 1	N-of-1 treatment with marketed drugs used on or off-label as per SOC.	Other: Patient-specific treatments
Group 2	N-of-1 treatment with drugs accessed from SAP.	Other: Patient-specific treatments
Group 3	N-of-1 treatment with non-marketed investigational agents.	Other: Patient-specific treatments

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patient-specific treatments	Other	Treatment will be decided specifically for the patient based on biomarker test results.	Group 1 Group 2 Group 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall response rate for the overall cohorts and the number of patients accessing precision targeted therapy		3 years

Secondary Outcomes

Measure	Description	Time Frame
Overall survival rate		5 years
Progression-free survival		5 years
Number of participants with adverse events as assessed by CTCAE v5.0

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria & Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients have advanced and rare cancer with limited treatment options.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amit Oza, Dr.	Contact	416 946 4450		amit.oza@uhn.ca

Overall Officials

Name	Affiliation	Role
Amit Oza, Dr.	University Health Network, Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Health Network, Princess Margaret Cancer Centre	Recruiting	Toronto	Ontario	M5G 2M9	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D035583	Rare Diseases

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided