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Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Sponsor: Revolution Medicines, Inc.
Summary
The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.
Official title: RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
900
Start Date
2026-03-09
Completion Date
2029-03
Last Updated
2026-08-27
Healthy Volunteers
No
Conditions
Interventions
daraxonrasib
oral tablets
gemcitabine
intravenous (IV) infusion
nab-paclitaxel
IV infusion
Locations (33)
Honor Health Research Institute
Scottsdale, Arizona, United States
University of California San Francisco
San Francisco, California, United States
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Cincinnati Cancer Center
Cincinnati, Ohio, United States
Taylor Cancer Research Center
Maumee, Ohio, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
SCRI - Texas Oncology Dallas
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Prince of Wales Hospital
Randwick, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Epworth HealthCare
East Melbourne, Victoria, Australia
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
São Paulo, Brazil
National Cancer Center - East
Kashiwa, Chiba, Japan
Cancer Institute Hospital - Japan Foundation for Cancer Research
Koto-Ku, Tokyo, Japan
Chiba Cancer Center
Chiba, Japan
NHO Kyushu Cancer Center
Fukuoka, Japan
Kyushu University Hospital
Fukuoka, Japan
Kanagawa Cancer Canter
Kanagawa, Japan
Osaka International Cancer Institute
Osaka, Japan
National Cancer Center - Tokyo
Tokyo, Japan
Wakayama Medical University Hospital
Wakayama, Japan
Yamaguchi University Hospital
Yamaguchi, Japan
National Taiwan University Hospital
Taipei, Taiwan
Queen Elizabeth Hospital - Birmingham
Birmingham, United Kingdom
Barts Hospital
London, United Kingdom
Royal Marsden Hospital - London
London, United Kingdom