A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic). The standard treatment is chemotherapy, but other treatments are needed to improve outcomes in people with pancreatic cancer. The first treatment that people usually receive is chemotherapy. At the time this study started, some of the main standard chemotherapies for pancreatic cancer were mFOLFIRINOX or NALIRIFOX. Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many ty

Trial Details

NCT ID
NCT07409272
Phase
PHASE3
Sponsor
Astellas Pharma Global Development, Inc.
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • Setidegrasib
  • Oxaliplatin
  • Leucovorin
  • Irinotecan
  • fluorouracil
  • liposomal irinotecan
Locations (sample)
  • Fullerton, California, United States|33.87029,-117.92534
  • Newport Beach, California, United States|33.61891,-117.92895
  • Jacksonville, Florida, United States|30.33218,-81.65565
  • Edgewood, Kentucky, United States|39.01867,-84.58189
  • Saint Louis Park, Minnesota, United States|44.9483,-93.34801

Key Eligibility Criteria

  • Participant has histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC) with documented Kirsten rat sarcoma viral oncogene homo…
  • Participant has no option for surgical resection or radiotherapy with curative intent.
  • Participant consents to and provides a baseline tumor tissue specimen for the study during screening. The sample must meet the requirements describ…
  • Participant has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 within 7 days prior to randomization.

For full eligibility, visit ClinicalTrials.gov.

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