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A Phase II Study of AGS-1C4D4 plus Gemcitabine in Patients with Metastatic Pancreatic Cancer
[Protocol 09-086]
- Full Title :
- A GLOBAL, MULTI CENTER, OPEN LABEL PHASE 2 STUDY OF AGS-1C4D4 GIVEN IN COMBINATION WITH GEMCITABINE IN SUBJECTS WITH METASTATIC PANCREATIC CANCER
- Purpose :
Gemcitabine is the standard chemotherapy for advanced pancreatic cancer. In this study, researchers want to evaluate the safety and effectiveness of adding an investigational drug called AGS-1C4D4 to gemcitabine therapy in patients with metastatic pancreatic cancer.
AGS-1C4D4 is a monoclonal antibody that binds to certain proteins on pancreatic cancer cells. Laboratory studies have shown that AGS-1C4D4 plus gemcitabine could stop pancreatic cancer cell growth. Patients will be randomly assigned to receive gemcitabine alone or with AGS-1C4D4.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of metastatic pancreatic cancer.
- Patients may not have had prior chemotherapy for metastatic disease.
- At least 4 weeks must have passed since completion of prior treatments and entry into the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Eileen O'Reilly at 212-639-6672.
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