Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)
Recruiting · NCT07252232 · Interventional (participants receive a specific treatment) · Lead sponsor: Revolution Medicines, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 23 US states.
- Mayo Clinic - Phoenix, Arizona, United States
- UC San Diego Moores Cancer Center - La Jolla, California, United States
- Cedars-Sinai Cancer at Cedars-Sinai Medical Center - Los Angeles, California, United States
- University of California, Los Angeles - Los Angeles, California, United States
- Stanford Cancer Institute - Palo Alto, California, United States
- University of California, San Francisco - San Francisco, California, United States
- Rocky Mountain Cancer Centers, LLP - Lakewood, Colorado, United States
- Hartford Healthcare - Hartford, Connecticut, United States
- Mayo Clinic - Jacksonville, Florida, United States
- University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center - Miami, Florida, United States
- Florida Cancer Specialists - St. Petersburg, Florida, United States
- Winship Cancer Institute, Emory University - Atlanta, Georgia, United States
- Community Health Network - Indianapolis, Indiana, United States
- University of Kansas Medical Center Research Institute, Inc. - Lawrence, Kansas, United States
- Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins & Sibley Memorial Hospital - Baltimore, Maryland, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Dana Farber Cancer Institute (DFCI) - Boston, Massachusetts, United States
- Mayo Clinic Cancer Center - Rochester, Minnesota, United States
- Saint Luke's Cancer Institute - Kansas City, Missouri, United States
- University of Nebraska Medical Center - Omaha, Nebraska, United States
- Comprehensive Cancer Centers of Nevada - Las Vegas, Nevada, United States
- Laura and Issac Perlmutter Cancer Center at NYU Langone-Ambulatory Care Center - New York, New York, United States
- Columbia University Medical Center - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- University of Rochester Medical Center - Rochester, New York, United States
- Duke Cancer Center - Durham, North Carolina, United States
- Taylor Cancer Research Center - Maumee, Ohio, United States
- Avera Cancer Institute - Sioux Falls, South Dakota, United States
- SCRI Oncology Partners - Nashville, Tennessee, United States
- Texas Oncology - DFW - Dallas, Texas, United States
- University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- Texas Oncology - Northeast Texas - Longview, Texas, United States
- University of Utah, Huntsman Cancer Institute - Salt Lake City, Utah, United States
- Virginia Cancer Specialists - Fairfax, Virginia, United States
- Froedtert Hospital and the Medical College of Wisconsin - Milwaukee, Wisconsin, United States
- Hospital Universitari Vall d'Hebron - VHIO - Barcelona, Spain
- Hospital Clinic de Barcelona - Barcelona, Spain
- University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Medical Centre - Birmingham, United Kingdom
- Dong-A University Hospital - Busan, South Korea
- National Cancer Center Hospital East - Chiba, Japan
- Beatson West of Scotland Cancer Centre - Glasgow, United Kingdom
- Universitaetsklinikum Heidelberg - Heidelberg, Germany
- Kyoto University Hospital - Kyoto, Japan
- The Royal Marsden NHS Foundation Trust, Royal Marsden Hospital-London - London, United Kingdom
- Imperial College Healthcare NHS Foundation Trust, Hammersmith Hospital - London, United Kingdom
- Hospital Universitario 12 de Octubre - Madrid, Spain
- The Christie NHS Foundation Trust - Manchester, United Kingdom
- Institut Paoli Calmettes - Marseille, France
- Fondazione IRCCS Istituto Nazionale dei Tumori - Milan, Italy
- IEO - Instituto Europeo di Oncologia - Milan, Italy
- IOV - Istituto Oncologico Veneto IRCCS - Padova, Italy
- Azienda Ospedaliero Universitaria Pisana - Pisa, Italy
- Pan American Oncology Trials, LLC - San Juan, Puerto Rico
- Seoul National University Hospital - Seoul, South Korea
- Asan Medical Center - Seoul, South Korea
- Samsung Medical Center - Seoul, South Korea
- Hospital Universitario Virgen del Rocio - Seville, Spain
- National Cancer Center Hospital - Tokyo, Japan
- Cancer Institute Hospital of JFCR - Tokyo, Japan
- Hospital Clinico Universitario de Valencia - Valencia, Spain
Showing 60 of 66 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →