Pancreatic Adenocarcinoma
Conditions
Brief summary
PFS, defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per RECIST v1.1 by Investigator, OS, defined as the time from randomization until death from any cause
Detailed description
PFS, defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per RECIST v1.1 by BICR, Objective response of PR or CR per RECIST v1.1, as assessed by Investigator, DOR, defined as the time from first evidence of objective response (PR or CR) per RECIST v1.1 to disease progression or death due to any cause, whichever occurs first, as assessed by Investigator, Incidence and severity of TEAEs, TRAEs, and SAEs, Change from baseline in clinical laboratory tests and vital signs, Predose and postdose blood concentrations of zoldonrasib and daraxonrasib, Change from baseline on the EORTC QLQ-PAN26 pain scale, Change from baseline on the EORTC QLQ-C30 global health status score
Interventions
Sponsors
Revolution Medicines Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per RECIST v1.1 by Investigator, OS, defined as the time from randomization until death from any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS, defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per RECIST v1.1 by BICR, Objective response of PR or CR per RECIST v1.1, as assessed by Investigator, DOR, defined as the time from first evidence of objective response (PR or CR) per RECIST v1.1 to disease progression or death due to any cause, whichever occurs first, as assessed by Investigator, Incidence and severity of TEAEs, TRAEs, and SAEs, Change from baseline in clinical laboratory tests and vital signs, Predose and postdose blood concentrations of zoldonrasib and daraxonrasib, Change from baseline on the EORTC QLQ-PAN26 pain scale, Change from baseline on the EORTC QLQ-C30 global health status score | — |
Outcome results
None listed