Pancreatic Cancer Clinical Trial
Official title:
A Global, Multi-center, Open-label, Phase 2 Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer
A study to evaluate AGS-1C4D4 administered in combination with Gemcitabine chemotherapy in subjects with Metastatic Pancreatic Cancer.
A disease assessment will be performed at study week 8 (± 3 days) by the investigator. The
assessment will be based both on changes in clinical symptoms, and radiographic images.
Subjects without evidence of disease progression may continue to receive treatment based on
their original treatment assignment until disease progression or intolerability. Disease
assessments will be performed every 8 weeks during the extended period. A safety follow-up
visit will occur 4 weeks after the last dose infusion of AGS-1C4D4 and/or gemcitabine.
Post-Treatment: Subjects terminating from protocol therapy for reasons unrelated to
documented disease progression will be followed by telephone contact every 2 months until
they begin a new anticancer therapy, their disease progresses, they die, become lost to
follow-up or withdrawal consent for further follow-up, whichever of these events occurs
first.
Overall survival: All subjects will be followed by telephone contact every 2 months until
death, loss to follow-up, or withdrawal of consent, whichever of these events occurs first.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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