A study to evaluate AGS-1C4D4 administered in combination with Gemcitabine chemotherapy in
subjects with Metastatic Pancreatic Cancer.
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Locations near you
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Full eligibility criteria for NCT00902291
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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)
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
All locations for NCT00902291
United States (15)
University of California San Diego Medical Center
La Jolla, California, United States, 92093
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, United States, 33435
University of Miami
Miami, Florida, United States, 33136
Medical Oncology LLC
Baton Rouge, Louisiana, United States, 70809
Annapolis Oncology Center
Annapolis, Maryland, United States, 21401
Dana Farber Cancer Center
Boston, Massachusetts, United States, 02115
Virginia G. Piper Cancer Center
Minneapolis, Minnesota, United States, 55407
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Regional Oncology Center
Syracuse, New York, United States, 13210
Kaiser Permanente Northwest Region Oncology Hematology
Portland, Oregon, United States, 97227
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
Baptist Regional Cancer Center
Knoxville, Tennessee, United States, 37920
Vanderbilt University Medical Center, Div. of Medical Oncology
Nashville, Tennessee, United States, 37232
Alan B. Pearson Regional Cancer Center Lynchburg Hematology Oncology Clinic
Lynchburg, Virginia, United States, 24501
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Centre Jean Bernard, Oncologie médicale
Le Mans Cedex, France
Centre Régional de Lutte Contre le Cancer-Centre Oscar Lambret
Hôpital du Haut Lèvêque, Service d'Hepato Gastroentérologie
Centre Hospitalier Universitaire de Poitiers
Poitiers Cedex, France
Hôpital Charles Nicolle
Russian Federation (9)
State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"
Arkhangelsk, Russian Federation
Regional Oncology Dispensary
Ivanovo, Russian Federation
Clinical Oncology Dispensary of Republic of Tatarstan
Kazan, Russian Federation
State Healthcare Institution "Leningrad Regional Oncologic Dispensary"
Kuzmolovo, Russian Federation
Non-state Healthcare Institution N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway"
Moscow, Russian Federation
Medical Radiology Research Center of Russian Medical Academy
Obninsk, Russian Federation
State Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"
Omsk, Russian Federation
State Educational Institution "S.M. Kirov Military Medical Academy of Ministry of Defense of Russia"
Saint Petersburg, Russian Federation
Saint Petersburg State Healthcare Institution "Municipal Clinical Oncology Dispensary"
St. Petersburg, Russian Federation
Hospital Clinic i Provincial de Barcelona, Servicio de Oncologia
Hospital Virgen de la Salud, Servicio Oncologia
View full eligibility
Tris trial is registered with FDA with number: NCT00902291. The sponsor of the trial is Astellas Pharma Inc and it is looking for 205 volunteers for the current phase.
Official trial title: A Global, Multi-center, Open-label, Phase 2 Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer
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