Adding a New Treatment to Chemotherapy for Patients with Pancreatic Cancer
NCT07409272 · RecruitingThis study looks at how effective and safe a medicine called setidegrasib is when given with two types of chemotherapy for pancreatic cancer. The focus is on adults with a specific faulty gene, known as the KRAS G12D mutation, who have cancer that has spread. The main goal is to see if setidegrasib helps people live longer than those who only receive a placebo with chemotherapy. Researchers also want to understand how well the body processes this medicine and its safety when used together with chemotherapy.
Locations and contact
This trial is running at 34 locations in 2 countries. All of them are currently recruiting.
United States28 locations · 28 recruiting
- AGH Singer Research InstitutePittsburgh, PennsylvaniaRecruiting
- Allina Health Cancer Institute - Hematology Cancer Care ServicesMinneapolis, MinnesotaRecruiting
- Atlantic Health - Overlook Medical CenterMorristown, New JerseyRecruiting
- Baptist MD Anderson Cancer InstituteJacksonville, FloridaRecruiting
- Brown University Health Cancer Institute - Division of Hematology/OncologyProvidence, Rhode IslandRecruiting
- Crosson Cancer Institute at Providence St. Jude Medical Center in FullertonFullerton, CaliforniaRecruiting
- HealthPartners Cancer Center at Regions HospitalSaint Paul, MinnesotaRecruiting
- HealthPartners Frauenshuh Cancer CenterSaint Louis Park, MinnesotaRecruiting
- Hoag Mem Hosp PresbyterianNewport Beach, CaliforniaRecruiting
- Houston Methodist Office of Graduate - Houston Methodist Neal Cancer Center at Texas Medical CenterHouston, TexasRecruiting
- Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew York, New YorkRecruiting
- Memorial Sloan Kettering Cancer Center - Main CampusNew York, New YorkRecruiting
- Mercy Cancer CenterFort Smith, ArkansasRecruiting
- Mercy CH Chub O'Reilly Cancer CenterSpringfield, MissouriRecruiting
- Mercy David C. Pratt Cancer Center - St. - Mercy Research - David C. Pratt Cancer CenterSt Louis, MissouriRecruiting
- Mercy Hospital Oklahoma City - Mercy Coletta Cancer Center - Oklahoma CityOklahoma City, OklahomaRecruiting
- NYU Long Island MineolaMineola, New YorkRecruiting
- Saint Elizabeth Medical Center, Inc. DBA St. Elizabeth Health CareEdgewood, KentuckyRecruiting
- Saint Joseph Hospital - Cancer Centers - St. Vincent Frontier Cancer CenterBillings, MontanaRecruiting
- The Alvin J. Siteman Cancer Center - Center for Advanced MedSt Louis, MissouriRecruiting
- University of Michigan Health - University of Michigan Medical CenterAnn Arbor, MichiganRecruiting
- University of RochesterRochester, New YorkRecruiting
- UT Southwestern Medical Center at DallasDallas, TexasRecruiting
- Utah Cancer SpecialistsSalt Lake City, UtahRecruiting
- UVA Emily Couric Cancer CenterCharlottesville, VirginiaRecruiting
- Virginia Cancer SpecialistsFairfax, VirginiaRecruiting
- Virginia Mason Franciscan Health - Virginia Mason Medical CenterSeattle, WashingtonRecruiting
- White Plains Hospital Center for Cancer Care - OncologyWhite Plains, New YorkRecruiting
Japan6 locations · 6 recruiting
- Japanese Foundation for Cancer Research - The Cancer Institute Hospital of JFCRKoto, TokyoRecruiting
- Kyushu Group - Kyushu Cancer CenterFukuoka, FukuokaRecruiting
- National Cancer Center Hospital East - Clinical Research Coordinating SectionKashiwa, ChibaRecruiting
- The University of Osaka HospitalSuita, OsakaRecruiting
- The University of Tokyo HospitalBunkyo-ku, TokyoRecruiting
- Yamaguchi University HospitalUbe-shi, YamaguchiRecruiting
Who can join
Adults aged 18 and older can join the study if they have been diagnosed with metastatic pancreatic cancer that shows the KRAS G12D mutation. They must not be able to have surgery or radiation to cure their cancer. The study is not open to those with certain other health issues or other active cancers that need treatment. The trial team will confirm if a person is eligible to participate.
What happens during the trial
Participants will be randomly placed into one of two groups. One group will receive setidegrasib along with chemotherapy (either mFOLFIRINOX or NALIRIFOX), while the other group will get a placebo with the same chemotherapy. Everyone will receive treatment for a cycle of 28 days, and the treatments will be given through an intravenous infusion.
The trial team
The trial is sponsored by Astellas Pharma Global Development, Inc. The medical director overseeing the study is affiliated with Astellas Pharma Global Development, Inc.
Important dates
The study began on February 17, 2026, and is expected to finish by August 31, 2029. The trial is currently enrolling new participants.
Additional information
The trial's ID number is NCT07409272. It is a Phase 3 study, meaning it is looking at how well the treatment works and how safe it is. This trial is regulated by the FDA and aims to include about 614 participants.
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