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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

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 California, Los Angeles
Los Angeles, California 90404

Hartford Healthcare
Hartford, Connecticut 06103
Contact:
Jonathan Steinmetz
(860) 972-4183
jonathan.steinmetz@hhchealth.org

Community Health Network
Indianapolis, Indiana 46250
Contact:
Adam Norris
(317) 621-3858
anorris@ecommunity.com

Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins
Baltimore, Maryland 21287

Saint Luke's Cancer Institute
Kansas City, Missouri 64111
Contact:
Marc Roth
(816) 932-2677
mroth@saint-lukes.org

Memorial Sloan Kettering Cancer Center
New York, New York 10065

Taylor Cancer Research Center
Maumee, Ohio 43537
Contact:
Principal Investigator
567-402-4502
sambrose@tcrcpt.org

Avera Cancer Institute
Sioux Falls, South Dakota 57105
Contact:
Heidi McKean
605-322-6900
heidi.mckean@avera.org

University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah 94112

Virginia Cancer Specialists
Fairfax, Virginia 22031

Pan American Oncology Trials, LLC
San Juan, Puerto Rico, Puerto Rico 00909
Contact:
Principal Investigator
787-407-3333
info@panoncologytrials.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.