Pancreatic Cancer PDAC Pancreatic Ductal Adenocarcinoma Resected Pancreatic Adenocarcinoma Pancreatic Cancer PDAC Pancreatic Ductal Adenocarcinoma RAS KRAS NRAS HRAS RAS Wild-Type RASolute Resectable Pancreatic Ductal Adenocarcinoma Resectable PDAC Resected Pancreatic Adenocarcinoma RAS Mutation
Conditions
Interventions
- Drug: daraxonrasib
-oral tablets
Sponsors
Revolution Medicines, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - At least 18 years old and has provided informed consent. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Histologically confirmed PDAC with successful (R0/R1) curative intent surgical resection and no evidence of recurrent or metastatic disease. - Must have received perioperative (neoadjuvant, adjuvant, or a combination of both) multi-agent chemotherapy. - Must have completed most recent treatment within the past 12 weeks. - Adequate organ function (bone marrow, liver, kidney, coagulation). - Documented RAS mutation status. - Able to take oral medications.
Exclusion criteria
Exclusion criteria: - Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors). - Any conditions that may affect the ability to take or absorb study drug. - Major surgery within 28 days prior to randomization. - Patient is unable or unwilling to comply with protocol-required study visits or procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Disease-Free Survival (DFS) per Investigator [Time Frame: Up to approximately 5 years] -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 |
|---|---|
| Secondary Outcome Measure: 1. Overall survival (OS) OS is defined as the time from randomization until death from any cause. [Time Frame: Up to approximately 5 years] 2. 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. Progression is per RECIST v1.1 as assessed by BICR. [Time Frame: Up to approximately 5 years] 3. 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. [Time Frame: Up to approximately 5 years] 4. 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. [Time Frame: Up to approximately 5 years] 5. Safety and tolerability of daraxonrasib Incidence of adverse events (AEs) and changes from baseline in vital signs, ECOG performance score, and clinical laboratory tests. [Time Frame: Up to approximately 5 years] 6. Pharmacokinetics (PK) characterization of daraxonrasib Blood concentrations of daraxonrasib over time [Time Frame: Up to approximately 5 years] | — |
Countries
Australia, Canada, France, Germany, Italy, Japan, Puerto Rico, South Korea, Spain, United Kingdom, United States
Contacts
Public ContactjRCT Call Center IQVIA services Japan G.K.
IQVIA services Japan G.K.
Outcome results
None listed