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

Phase 3RecruitingNCT07252232

Revolution Medicines, Inc.500 enrolled

Overview

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

Conditions

Pancreatic Cancer PDAC PDAC - Pancreatic Ductal Adenocarcinoma Resectable Pancreatic Ductal Adenocarcinoma (PDAC)Resected Pancreatic Adenocarcinoma

Interventions

daraxonrasibDRUG

oral tablets

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Hartford Healthcare

Hartford, Connecticut, United States

NOT_YET_RECRUITING

Community Health Network

Indianapolis, Indiana, United States

RECRUITING

Saint Luke's Cancer Institute

Kansas City, Missouri, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Revolution Medicines Study Director

CONTACT

1-844-2-REVMED medinfo@revmed.com

Data from ClinicalTrials.gov

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