Advanced Cancer, Rare Diseases
Conditions
Keywords
single patient protocols
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
Interventions
OTHERPatient-specific treatments
Treatment will be decided specifically for the patient based on biomarker test results.
Sponsors
University Health Network, Toronto
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate for the overall cohorts and the number of patients accessing precision targeted therapy | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival rate | 5 years | — |
| Progression-free survival | 5 years | — |
| Number of participants with adverse events as assessed by CTCAE v5.0 | 3 years | 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). |
Countries
Canada
Contacts
Primary ContactAmit Oza, Dr.
Outcome results
None listed