Study on Chemotherapy With or Without INCB161734 for Untreated KRAS G12D-Mutated Metastatic Pancreatic Cancer
Sponsor: Incyte Corporation
ClinicalTrials ID:NCT07522073
This clinical trial is testing whether adding a new drug, INCB161734, to standard chemotherapy can improve treatment outcomes for patients with metastatic pancreatic cancer that has a specific KRAS G12D mutation and has not been treated before.
Patient Parameters
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Program Overview
The aim of this study is to determine if combining a new drug, INCB161734, with standard chemotherapy is safe and more effective than chemotherapy alone for patients with metastatic pancreatic ductal adenocarcinoma (PDAC) that has a KRAS G12D mutation. This study is for patients who have not received any prior treatment for their metastatic cancer.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of metastatic pancreatic cancer with a KRAS G12D mutation.
- Have not received any previous treatment for metastatic cancer.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate organ function as determined by specific medical tests.
Exclusion Criteria
- Have previously been treated with any KRAS inhibitor.
- Have a chronic or active infection that requires treatment within one week before starting the study drug.
- Have known active cancer that has spread to the brain or central nervous system.
Other specific criteria may apply as defined by the study protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Investigative Site US058 | 35233 | Birmingham | Alabama |
| Investigative Site US016 | 99508 | Anchorage | Alaska |
| Investigative Site US026 | 85224 | Chandler | Arizona |
| Investigative Site US045 | 85719 | Tucson | Arizona |
| Investigative Site US051 | 91010 | Duarte | California |
| Investigative Site US048 | 92708 | Fountain Valley | California |
| Investigative Site US049 | 92612 | Irvine | California |
| Investigative Site US054 | 92093 | La Jolla | California |
| Investigative Site US027 | 90027 | Los Angeles | California |
| Investigative Site US036 | 90033 | Los Angeles | California |
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