A Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer

This is an interventional treatment trial for Carcinoma, Pancreatic Ductal focused on measuring Clinical Trial, Phase II, Combination Drug Therapy, Gemcitabine, AGS-1C4D4, Pancreatic Cancer Read More

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:

  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Platelet count ≥ 100 x 109/L
  • Hemoglobin ≥ 9 g/dL (transfusion independent)

• Renal function, as follows:

  • Creatinine ≤ 2.0 mg/dL

• Hepatic function, as follows:

  • Aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤ 5 x ULN if known liver metastases.
  • Alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5 x ULN if known liver metastases
  • Bilirubin ≤ 2 x ULN
• INR < 1.3 (or ≤ 3 if on warfarin for therapeutic anti-coagulation)

Exclusion Criteria:

• Prior systemic therapy for metastatic pancreatic cancer

  • Subjects who have received adjuvant treatment with gemcitabine and who had relapse metastatically are allowed
  • Subjects with advanced local disease who have received treatment with gemcitabine and in whom progression has been observed with the onset of metastases less than 6 months are excluded
• 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:

  • Curatively resected non-melanomatous skin cancer
  • Other malignancy curatively treated with no known active disease present and no treatment administered for the last 3 years
• 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