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
Mayo Clinic
Phoenix, Arizona 85054
Phoenix, Arizona 85054
UC San Diego Moores Cancer Center
La Jolla, California 92037
La Jolla, California 92037
Cedars-Sinai Cancer at Cedars-Sinai Medical Center
Los Angeles, California 90048
Los Angeles, California 90048
University of California, Los Angeles
Los Angeles, California 90404
Los Angeles, California 90404
Stanford Cancer Institute
Palo Alto, California 94304
Palo Alto, California 94304
University of California, San Francisco
San Francisco, California 94143
San Francisco, California 94143
Rocky Mountain Cancer Centers, LLP
Lakewood, Colorado 80228
Lakewood, Colorado 80228
Hartford Healthcare
Hartford, Connecticut 06103
Hartford, Connecticut 06103
University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center
Miami, Florida 33136
Miami, Florida 33136
Florida Cancer Specialists
St. Petersburg, Florida 33701
St. Petersburg, Florida 33701
Contact:
Study Coordinator
727-216-1143
Study Coordinator
727-216-1143
Winship Cancer Institute, Emory University
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Community Health Network
Indianapolis, Indiana 46250
Indianapolis, Indiana 46250
University of Kansas Medical Center Research Institute, Inc.
Lawrence, Kansas 66045
Lawrence, Kansas 66045
Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins & Sibley Memorial Hospital
Baltimore, Maryland 21287
Baltimore, Maryland 21287
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Dana Farber Cancer Institute (DFCI)
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Contact:
617-632-3000
617-632-3000
Mayo Clinic Cancer Center
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Saint Luke's Cancer Institute
Kansas City, Missouri 64111
Kansas City, Missouri 64111
University of Nebraska Medical Center
Omaha, Nebraska 68198
Omaha, Nebraska 68198
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169
Las Vegas, Nevada 89169
Laura and Issac Perlmutter Cancer Center at NYU Langone-Ambulatory Care Center
New York, New York 10016
New York, New York 10016
Columbia University Medical Center
New York, New York 10032
New York, New York 10032
Memorial Sloan Kettering Cancer Center
New York, New York 10065
New York, New York 10065
University of Rochester Medical Center
Rochester, New York 14642
Rochester, New York 14642
Duke Cancer Center
Durham, North Carolina 27710
Durham, North Carolina 27710
Taylor Cancer Research Center
Maumee, Ohio 43537
Maumee, Ohio 43537
Avera Cancer Institute
Sioux Falls, South Dakota 57105
Sioux Falls, South Dakota 57105
SCRI Oncology Partners
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Texas Oncology - DFW
Dallas, Texas 75246
Dallas, Texas 75246
Texas Oncology - Northeast Texas
Longview, Texas 75601
Longview, Texas 75601
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah 94112
Salt Lake City, Utah 94112
Virginia Cancer Specialists
Fairfax, Virginia 22031
Fairfax, Virginia 22031
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
Pan American Oncology Trials, LLC
San Juan, Puerto Rico 00909
San Juan, Puerto Rico 00909
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.