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NCT07409272 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer
A Phase 3 study of Pancreatic Cancer and Metastatic Pancreatic Adenocarcinoma, sponsored by Astellas Pharma Global Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 614
- Enrollment target
- 2
- Study locations
NCT07409272 is a Phase 3 study of Pancreatic Cancer and Metastatic Pancreatic Adenocarcinoma that is actively recruiting participants, run by Astellas Pharma Global Development. The registered enrollment target is 614 participants, above the 391-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (57% higher). The trial reports 2 study locations across 2 states.
The verdict
NCT07409272, a Phase 3 study of Pancreatic Cancer and Metastatic Pancreatic Adenocarcinoma, is actively recruiting participants, sponsored by Astellas Pharma Global Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 614 participants
- Enrollment target
- 2
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 614 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 391-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (57% higher). The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
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.
NCT07409272 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, New York.
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.
What interventions are being tested in trial NCT07409272?
The interventions under investigation include: Leucovorin (DRUG), Oxaliplatin (DRUG), Irinotecan (DRUG), Setidegrasib (DRUG), fluorouracil (DRUG).
Who is sponsoring clinical trial NCT07409272?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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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