Resected Pancreatic Ductal Adenocarcinoma (PDAC)
Conditions
Brief summary
Disease-Free Survival (DFS) per Investigator DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per response evaluation criteria in solid tumors (RECIST) v1.1 as assessed by Investigator.
Detailed description
Overall survival (OS) - OS is defined as the time from randomization until death from any cause, DFS per blinded independent central review (BICR) - DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per RECIST v1.1 as assessed by BICR, DFS Rate at 1 year and 2 years - DFS rate defined as percentage of patients who are disease free at 1 year and 2 years, respectively, OS rate at 1 year and 2 years - OS rate defined as percentage of patients who are alive at 1 year and 2 years, respectively., Safety and tolerability of daraxonrasib - Incidence of adverse events (AEs) and changes from baseline in vital signs, ECOG performance score, and clinical laboratory tests, Pharmacokinetics (PK) - Predose concentration of daraxonrasib
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-Free Survival (DFS) per Investigator DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per response evaluation criteria in solid tumors (RECIST) v1.1 as assessed by Investigator. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) - OS is defined as the time from randomization until death from any cause, DFS per blinded independent central review (BICR) - DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per RECIST v1.1 as assessed by BICR, DFS Rate at 1 year and 2 years - DFS rate defined as percentage of patients who are disease free at 1 year and 2 years, respectively, OS rate at 1 year and 2 years - OS rate defined as percentage of patients who are alive at 1 year and 2 years, respectively., Safety and tolerability of daraxonrasib - Incidence of adverse events (AEs) and changes from baseline in vital signs, ECOG performance score, and clinical laboratory tests, Pharmacokinetics (PK) - Predose concentration of daraxonrasib | — |