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

Completed · Phase 2

Conditions studied: Carcinoma, Pancreatic Ductal, Pancreatic Cancer, Pancreatic Disease

In brief

A study to evaluate AGS-1C4D4 administered in combination with Gemcitabine chemotherapy in subjects with Metastatic Pancreatic Cancer.

Key facts

Study ID

NCT00902291

Run by

Astellas Pharma Inc

People needed

205

Starts

2009-04-01

Expected to finish

2012-04-01

Last updated by the study team

2015-09-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of California San Diego Medical Center — La Jolla, California, United States
• Palm Beach Institute of Hematology and Oncology — Boynton Beach, Florida, United States
• University of Miami — Miami, Florida, United States
• Medical Oncology LLC — Baton Rouge, Louisiana, United States
• Annapolis Oncology Center — Annapolis, Maryland, United States
• Dana Farber Cancer Center — Boston, Massachusetts, United States
• Virginia G. Piper Cancer Center — Minneapolis, Minnesota, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Regional Oncology Center — Syracuse, New York, United States
• Kaiser Permanente Northwest Region Oncology Hematology — Portland, Oregon, United States
• Cancer Centers of the Carolinas — Greenville, South Carolina, United States
• Baptist Regional Cancer Center — Knoxville, Tennessee, United States
• Vanderbilt University Medical Center, Div. of Medical Oncology — Nashville, Tennessee, United States
• Alan B. Pearson Regional Cancer Center Lynchburg Hematology Oncology Clinic — Lynchburg, Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Cross Cancer Institute — Edmonton, Alberta, Canada
• Juravinski Cancer Centre — Hamilton, Ontario, Canada
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• Chu Estaing — Clermont-Ferrand, France
• Centre Jean Bernard, Oncologie médicale — Le Mans, France
• Centre Régional de Lutte Contre le Cancer-Centre Oscar Lambret — Lille, France
• Hôpital du Haut Lèvêque, Service d'Hepato Gastroentérologie — Pessac, France
• Centre Hospitalier Universitaire de Poitiers — Poitiers, France
• Hôpital Charles Nicolle — Rouen, France
• State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary" — Arkhangelsk, Russia

Full record on ClinicalTrials.gov

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