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 and BICR, 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 and BICR, Incidence and severity of TEAEs, TRAEs, and SAEs, Clinically significant changes in laboratory test values and vital signs, Change from baseline on the EORTC-QLQ-PAN26 pain scale, Change from baseline on the EORTC-QLQ-C30 global health status score, Predose and postdose blood concentrations of zoldonrasib
Interventions
Sponsors
Eligibility
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 and BICR, 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 and BICR, Incidence and severity of TEAEs, TRAEs, and SAEs, Clinically significant changes in laboratory test values and vital signs, Change from baseline on the EORTC-QLQ-PAN26 pain scale, Change from baseline on the EORTC-QLQ-C30 global health status score, Predose and postdose blood concentrations of zoldonrasib | — |