Study on the Effectiveness and Safety of Setidegrasib with Chemotherapy for Pancreatic Cancer
Sponsor: Astellas Pharma Global Development, Inc.
ClinicalTrials ID:NCT07409272
This clinical trial is testing a new treatment, setidegrasib, combined with standard chemotherapy options, to see if it can help people with pancreatic cancer live longer and delay the return of cancer symptoms.
Patient Parameters
| Parameter | Options |
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Program Overview
Pancreatic cancer is often diagnosed late, making it hard to treat. By the time it's found, it usually has spread to other parts of the body. Chemotherapy is the standard treatment, but new treatments are needed to improve outcomes. This study is testing setidegrasib, a new drug given with chemotherapy, in people with pancreatic cancer who have a specific gene mutation called KRAS G12D. The study aims to find out if this combination helps people live longer and delays cancer symptoms. Participants will receive either setidegrasib or a placebo, along with chemotherapy, and will be monitored for safety and effectiveness.
Eligibility Criteria
Inclusion Criteria
- Have confirmed metastatic pancreatic cancer with a KRAS G12D mutation.
- Surgery or radiotherapy is not an option to cure the cancer.
- Agree to provide a tumor sample for the study.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have adequate organ function based on recent lab tests.
- Agree not to participate in another interventional study while in this study.
Exclusion Criteria
- Have a different type of pancreatic cancer or cancer with specific features.
- Have had another active cancer within the past 2 years, except for certain skin or localized cancers.
- Have chronic bowel disease, bowel obstruction, or severe diarrhea.
- Have nerve damage affecting daily activities.
- Have fluid buildup in the abdomen or chest requiring treatment.
- Have untreated or symptomatic blood clots in the lungs.
- Have lung disease or fibrosis.
- Have uncontrolled seizures.
- Have a specific genetic condition affecting drug metabolism.
- Have had recent heart problems or surgery.
- Have received prior treatment for metastatic pancreatic cancer, except for limited doses during screening.
- Have been treated with a KRAS G12D-targeted drug before.
- Have a prolonged QT interval on an ECG.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Crosson Cancer Institute at Providence St. Jude Medical Center in Fullerton | 92835 | Fullerton | California |
| Hoag Mem Hosp Presbyterian | 92663 | Newport Beach | California |
| Baptist MD Anderson Cancer Institute | 32207 | Jacksonville | Florida |
| Saint Elizabeth Medical Center, Inc. DBA St. Elizabeth Health Care | 41017 | Edgewood | Kentucky |
| HealthPartners Frauenshuh Cancer Center | 55426 | Saint Louis Park | Minnesota |
| HealthPartners Cancer Center at Regions Hospital | 55101 | Saint Paul | Minnesota |
| NYU Long Island Mineola | 11501 | Mineola | New York |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | 10016 | New York | New York |
| White Plains Hospital Center for Cancer Care - Oncology | 10601 | White Plains | New York |
| UT Southwestern Medical Center at Dallas | 75390 | Dallas | Texas |
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