Pancreatic Cancer, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma (PDAC), Resected Pancreatic Adenocarcinoma
Conditions
Keywords
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
Brief summary
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.
Detailed description
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.
Interventions
DRUGdaraxonrasib
oral tablets
Sponsors
Revolution Medicines, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* 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 | Description |
|---|---|---|
| Disease-Free Survival (DFS) per Investigator | 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 | Description |
|---|---|---|
| Overall survival (OS) | Up to approximately 5 years | OS is defined as the time from randomization until death from any cause. |
| OS rate at 1 year and 2 years | Up to approximately 2 years | OS rate defined as percentage of patients who are alive at 1 year and 2 years, respectively. |
| DFS Rate at 1 year and 2 years | Up to approximately 2 years | DFS rate defined as percentage of patients who are disease free at 1 year and 2 years, respectively. |
| Safety and tolerability of daraxonrasib | Up to approximately 5 years | Incidence of adverse events (AEs) and changes from baseline in vital signs, ECOG performance score, and clinical laboratory tests. |
| Pharmacokinetics (PK) | Up to Cycle 4 Day 1 (Day 85) | Predose concentration of daraxonrasib |
| DFS per blinded independent central review (BICR) | 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 RECIST v1.1 as assessed by BICR. |
Countries
Puerto Rico, United States
Contacts
CONTACTRevolution Medicines Study Director
Outcome results
None listed