The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard of care (SOC) observation only.
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve disease-free survival (DFS) compared to SOC observation in patients with resected PDAC who have completed neoadjuvant and/or adjuvant chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
oral tablets
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.
Time frame: Up to approximately 5 years
Overall survival (OS)
OS is defined as the time from randomization until death from any cause.
Time frame: Up to approximately 5 years
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.
Time frame: Up to approximately 5 years
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 2 years
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 2 years
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
Pharmacokinetics (PK)
Predose concentration of daraxonrasib
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mayo Clinic
Phoenix, Arizona, United States
RECRUITINGHonorHealth Research Institute
Scottsdale, Arizona, United States
RECRUITINGUC San Diego Moores Cancer Center
La Jolla, California, United States
RECRUITINGCedars-Sinai Cancer at Cedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGUniversity of California, Los Angeles
Los Angeles, California, United States
RECRUITINGStanford Cancer Institute
Palo Alto, California, United States
RECRUITINGUniversity of California, San Francisco
San Francisco, California, United States
RECRUITINGRocky Mountain Cancer Centers, LLP
Lakewood, Colorado, United States
RECRUITINGHartford Healthcare
Hartford, Connecticut, United States
RECRUITINGMayo Clinic
Jacksonville, Florida, United States
RECRUITING...and 64 more locations
Time frame: Up to Cycle 4 Day 1 (Day 85)