A Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer
Sponsored by Astellas Pharma Inc
About this trial
Last updated 11 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 14 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
* Pathologically confirmed metastatic adenocarcinoma of the pancreas (AJCC Stage IV). Subjects with islet cell neoplasms are excluded
* Non-measurable or measurable disease based on the RECIST criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Life expectancy of > 3 months
* Hematologic function, as follows:
* Renal function, as follows:
* Hepatic function, as follows:
* INR < 1.3 (or ≤ 3 if on warfarin for therapeutic anti-coagulation)
Exclusion Criteria
* Prior systemic therapy for metastatic pancreatic cancer
* Chemotherapy and/or radiation within 4 weeks of study enrollment
* Prior monoclonal antibody therapy within 60 days of study enrollment
* Known brain or leptomeningeal disease
* History of other primary malignancy, unless:
* Active angina or Class III or IV Congestive Heart Failure (New York Heart Association CHF Functional Classification System)
* Use of any investigational product within 4 weeks of study enrollment
* Major surgery (that requires general anesthesia) within 4 weeks before study enrollment
* Women who are pregnant (confirmed by positive pregnancy test) or lactating
* Man or woman of childbearing potential not consenting to use adequate contraceptive precautions during the course of the study and for 4 weeks after the last AGS-1C4D4 and/or gemcitabine infusion administration
* Subject known to be human immunodeficiency, hepatitis B or hepatitis C virus positive
* Active serious infection not controlled with antibiotics
