Phase I Study of Lonsurf in Combination with Gemcitabine and Nab-Paclitaxel in Patients with Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
Investigating the Safety and Effects of a Chemotherapy Combination for Pancreatic Cancer
Brief description of study.
The purpose of this study is to see whether a chemotherapy drug called Lonsurf (TAS-102) could be given safely with other chemotherapy agents (gemcitabine and nab-paclitaxel), and to assess the good and bad effects this treatment might have. Gemcitabine and nab-paclitaxel are approved by the Food and Drug Administration (FDA) for the treatment of pancreatic cancer.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: pancreatic cancer,Pancreatic Ductal Adenocarcinoma
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria
Untreated locally advanced PDAC
Histologically or cytologically confirmed PDAC
Adequate organ function
Women of childbearing potential definition (WOCBP) must have a negative serum or urine pregnancy test performed within 14 days prior to initiation of study treatment.
This study investigates the safety and effects of combining an investigational medication with other chemotherapy agents for the treatment of pancreatic cancer. Pancreatic cancer is a disease where cells in the pancreas grow uncontrollably. The purpose of this study is to see how well this combination works and to identify any side effects.
Participants in the study will receive a combination of chemotherapy treatments. Chemotherapy is a type of cancer treatment that uses drugs to stop the growth of cancer cells. The study will involve regular monitoring and assessments to evaluate the treatment's impact on the participants.
- Who can participate: Adults with untreated locally advanced pancreatic cancer, confirmed through tests, can participate. Participants must have adequate organ function and women of childbearing potential must test negative for pregnancy before starting the study.
- Study details: Participants will receive a combination of chemotherapy drugs, including an investigational medication. The treatment will be administered under close supervision to monitor safety and effects.