Umbrella Study for Single Patient Treatments in Oncology

Advanced Cancer Clinical Trial

— UNIQUE  

Official title:

UNIQUE: Umbrella N-of-1 Tumor Trials - Umbrella Protocol for Oncology Single Patient Protocols

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06285500
• Other study ID #: UNIQUE
• Secondary ID: 23-5095
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: February 1, 2029

Study information

• Verified date: February 2024
• Source: University Health Network, Toronto
• Contact: Amit Oza, Dr.
• Phone: 416 946 4450
• Email: amit.oza[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to collect data on how advanced and rare cancers respond to biomarker-based treatments.

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. There is no additional visit or procedure required to participate in this study. 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 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 1, 2029
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Rare Diseases

Intervention

Other:
• Patient-specific treatments
Treatment will be decided specifically for the patient based on biomarker test results.

Locations

Country	Name	City	State
Canada	University Health Network, Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate for the overall cohorts and the number of patients accessing precision targeted therapy		3 years
Secondary	Overall survival rate		5 years
Secondary	Progression-free survival rate		5 years
Secondary	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).	5 years