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Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Sponsor: Revolution Medicines, Inc.
Summary
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.
Official title: RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of Daraxonrasib (RMC-6236) Versus Investigator's Choice of Standard of Care Therapy in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
501
Start Date
2024-10-16
Completion Date
2027-12
Last Updated
2025-12-12
Healthy Volunteers
No
Interventions
RMC-6236
Oral Tablets
Gemcitabine
intravenous (IV) infusion
nab-paclitaxel
IV infusion
Irinotecan
IV infusion
Liposomal irinotecan
IV infusion
5-fluorouracil
IV infusion
leucovorin
IV infusion
Oxaliplatin
IV infusion
Locations (60)
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic Cancer Center - Phoenix
Phoenix, Arizona, United States
City of Hope-Duarte
Duarte, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
UC San Diego Health Moores Cancer Center
San Diego, California, United States
Mission Hall UCSF
San Francisco, California, United States
Rocky Mountain Cancer
Aurora, Colorado, United States
Mayo Clinic Cancer Center - Florida
Jacksonville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Cancer Care Centers of Brevard Inc
Palm Bay, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
The Queen's Medical Center
Honolulu, Hawaii, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
Johns Hopkins
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Mayo Clinic Cancer Center - Rochester
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
NYU Lagone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Abramson Cancer Center Clinical Research Unit
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute (Tennessee)
Nashville, Tennessee, United States
Texas Oncology Sammons
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology - Central South
Irving, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Institut Paoli Calmettes
Marseille, France
Centre Eugene Marquis
Rennes, France
Hopital Paul Brousse
Villejuif, France
Gustave Roussy
Villejuif, France
Charité Universitätsmedizin, Campus Berlin Mitte
Berlin, Germany
Nationales Centrum fur
Heidelberg, Germany
Universitatsklinikum Ulm, Zentru
München, Germany
Universitatsklinikum Ulm
Ulm, Germany
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
IEO-Istituto Europeo di Oncologia
Milan, Italy
IOV-Istituto Oncologico
Padova, Italy
Azienda Ospedaliera
Pisa, Italy
National Cancer Center
Chiba, Japan
Aichi Cancer Center
Nagoya, Japan
Osaka International Cancer
Osaka, Japan
National Cancer Center Hospital
Tokyo, Japan
Cancer Institute Hospital of JFCR
Tokyo, Japan
Kanagawa Cancer Center
Yokohama, Japan
Pan-American Center for Oncology Trials
San Juan, Puerto Rico
Hospital Unversitari
Barcelona, Spain
Hospital 12 de Octubre
Madrid, Spain
Clinica Universidad de Navarra
Pamplona, Spain
Hospital Clinico de Valencia
Valencia, Spain