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A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer
NCT07409272 · View on ClinicalTrials.gov ↗
Study Summary
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 types of cancer are caused by changes in certain genes, making them faulty. Many people with pancreatic cancer have a faulty KRAS gene. One such change in the KRAS gene is called a G12D mutation. Researchers are looking for ways to stop the actions of abnormal proteins made from the KRAS G12D mutation. This study is about setidegrasib given with chemotherapy in people with pancreatic cancer who have the KRAS G12D mutation. Before setidegrasib can become an approved treatment, clinical studies need to be completed to understand how it works and how safe it is. The main aim is to learn if people who are given setidegrasib with chemotherapy live for longer than people who are given placebo with chemotherapy. Other aims are to learn if setidegrasib delays the cancer and symptoms returning, how the body processes setidegrasib, and its safety, when given with chemotherapy. People in this study will be adults with metastatic pancreatic cancer with the G12D mutation in their KRAS gene. Surgery or radiotherapy will not be an option to cure their cancer. People cannot take part if the cancer cells have spread to the thin tissue covering the brain and spinal cord (leptomeningeal disease), have symptoms of cancer in the brain or nervous system, or have recently had some other cancers that required treatment. In this study, people are given either setidegrasib with mFOLFIRINOX or NALIRIF
Conditions Studied
Interventions
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG Irinotecan
- DRUG Setidegrasib
- DRUG fluorouracil
Study Locations (2)
Florida
- Baptist MD Anderson Cancer Institute — Jacksonville
New York
- Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 614 participants |
| Start Date | 2026-02-17 |
| Est. Completion | 2029-08-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07409272
The ClinicalTrials.gov registry entry for NCT07409272 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 614 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 172 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Pancreatic Cancer appearing as the primary indexed condition, and to 5 interventions — of which Leucovorin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07409272 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07409272 about?
NCT07409272 is a clinical study titled "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 tre...
What is the current status of trial NCT07409272?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 614 participants. The study started on 2026-02-17. Estimated completion is 2029-08-31.
What conditions does trial NCT07409272 study?
This clinical trial studies the following conditions: Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma, Metastatic Pancreatic Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07409272?
The interventions under investigation include: Leucovorin (DRUG), Oxaliplatin (DRUG), Irinotecan (DRUG), Setidegrasib (DRUG), fluorouracil (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07409272?
This trial is sponsored by Astellas Pharma Global Development, which has 172 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07409272 being conducted?
This trial has 2 study locations across Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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