Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Start Date
3/9/2026
Completion Date
3/1/2029
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.
Detailed Description
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib monotherapy or daraxonrasib plus gemcitabine and nab-paclitaxel will improve progression-free survival and/or overall survival compared with standard gemcitabine and nab-paclitaxel when given as first-line treatment in patients with metastatic pancreatic adenocarcinoma. Patients will be randomized to one of three arms: daraxonrasib (Arm A), daraxonrasib + gemcitabine and nab-paclitaxel (Arm B), or gemcitabine and nab-paclitaxel (Arm C).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
daraxonrasib
gemcitabine
nab-paclitaxel
Conditions
Locations
Honor Health Research Institute
Scottsdale, Arizona 85258
United States
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida 33612
United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21287
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada 89052
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
University of Cincinnati Cancer Center
Cincinnati, Ohio 45219
United States
Taylor Cancer Research Center
Maumee, Ohio 43537
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
SCRI - Texas Oncology Dallas
Dallas, Texas 95246
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
Virginia Mason Medical Center
Seattle, Washington 98101
United States
Calvary Mater Newcastle
Waratah, New South Wales 2298
Australia
National Cancer Center - East
Kashiwa, Chiba 277-8577
Japan
Cancer Institute Hospital - Japan Foundation for Cancer Research
Koto-Ku, Tokyo 135-8550
Japan
NHO Kyushu Cancer Center
Fukuoka, 811-1395
Japan
Kanagawa Cancer Canter
Kanagawa, 241-0815
Japan
Wakayama Medical University Hospital
Wakayama, 641-8510
Japan
Yamaguchi University Hospital
Yamaguchi, 755-8505
Japan