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.
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 Type
OBSERVATIONAL
Enrollment
400
Treatment will be decided specifically for the patient based on biomarker test results.
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, Canada
RECRUITINGOverall response rate for the overall cohorts and the number of patients accessing precision targeted therapy
Time frame: 3 years
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
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).
Time frame: 3 years
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