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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
2026-10-02
Healthy Volunteers
No
Conditions
Interventions
daraxonrasib
oral tablets
gemcitabine
intravenous (IV) infusion
nab-paclitaxel
IV infusion
Locations (82)
Mayo Clinic - Scottsdale
Phoenix, Arizona, United States
Honor Health Research Institute
Scottsdale, Arizona, United States
University of California Los Angeles Health - Hematology/Oncology
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Mayo Clinic Cancer Center- Florida
Jacksonville, Florida, 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
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic Cancer Center- Rochester
Rochester, Minnesota, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, 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
St. George Hospital
Kogarah, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Epworth HealthCare
East Melbourne, Victoria, Australia
Austin Health, Olivia Newton-John Cancer Research & Wellness Centre
Heidelberg, Victoria, Australia
Krankenhaus der Barmherzigen Brüder Wien-Klinisch wissenschaftliche Studien
Vienna, Austria
Institut Jules Bordet
Anderlecht, Belgium
UZ Leuven (Univ Ziekenhuis Leuven)
Leuven, Belgium
CEPON - Centro de Pesquisa Oncologicas de Santa Catarina
Florianópolis, Santa Catarina, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
São Paulo, Brazil
Sunnybrook Research Institute
Toronto, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
McGill University - Dept. Oncology Clinical Research Program
Montreal, Quebec, Canada
Klinikum der Universitaet Muenchen Campus Grosshadern
München, Germany
The Chinese University of Hong Kong
Hong Kong, Sha Tin, Hong Kong
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Istituto Oncologico Veneto IRCCS
Padova, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Azienda Ospedaliera Card. G. Panico
Tricase, Italy
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
Verona, Italy
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
Erasmus Medisch Centrum
Rotterdam, Netherlands
St. Antonius Ziekenhuis
Utrecht, Netherlands
National Cancer Centre Singapore
Singapore, Singapore
Curie Oncology Pte Ltd
Singapore, Singapore
Kyungpook National University Chilgok Hospital
Daegu, Republic of Korea, South Korea
Dong-A University Hospital
Busan, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center - PPDS
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz - PPDS
Madrid, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Torbay Hospital
Torquay, Devon, United Kingdom
Queen Elizabeth Hospital - Birmingham
Birmingham, United Kingdom
NHS Cambridge of Addenbrooke Hospital
Cambridge, United Kingdom
The Clatterbridge Cancer Centre
Liverpool, United Kingdom
Barts Hospital
London, United Kingdom
Royal Free Hospital
London, United Kingdom
Guy's Hospital
London, United Kingdom
Royal Marsden Hospital - London
London, United Kingdom
Sarah Cannon Research Institute UK
London, United Kingdom
University College London Hospital
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom