Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)
Purpose
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.
Conditions
- Pancreatic Cancer
- PDAC
- PDAC - Pancreatic Ductal Adenocarcinoma
- Resectable Pancreatic Ductal Adenocarcinoma (PDAC)
- Resected Pancreatic Adenocarcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental daraxonrasib |
study drug |
|
|
No Intervention SOC Observation |
Patients randomized to the comparator control arm will receive SOC observation. |
|
Recruiting Locations
University of Kansas Medical Center Research Institute, Inc.
Lawrence, Kansas 66045
Lawrence, Kansas 66045
More Details
- Status
- Recruiting
- Sponsor
- Revolution Medicines, Inc.
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.