Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) (RASolute 304)

Revolution Medicines

Status and phase

Enrolling

Phase 3

Conditions

Resected Pancreatic Adenocarcinoma

PDAC - Pancreatic Ductal Adenocarcinoma

PDAC

Resectable Pancreatic Ductal Adenocarcinoma (PDAC)

Pancreatic Cancer

Treatments

Drug: daraxonrasib

Study type

Interventional

Funder types

Industry

Identifiers

NCT07252232

RMC-6236-304

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.