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

ArmDescriptionAssigned Intervention
Experimental
daraxonrasib 		study drug
  • Drug: daraxonrasib
    oral tablets
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

More Details

Status
Recruiting
Sponsor
Revolution Medicines, Inc.

Study Contact

Revolution Medicines Study Director
1-844-2-REVMED
medinfo@revmed.com

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.