Spots Global Cancer Trial Database for A Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer
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Trial Identification
Brief Title: A Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer
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
Study ID: NCT00902291
Study Description
Brief Summary: A study to evaluate AGS-1C4D4 administered in combination with Gemcitabine chemotherapy in subjects with Metastatic Pancreatic Cancer.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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 Cedex, , 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 Cedex, , France
Hôpital Charles Nicolle, Rouen, , France
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, Barcelona, , Spain
, Madrid, , Spain
Hospital Virgen de la Salud, Servicio Oncologia, Toledo, , Spain
Contact Details
Name: Chief Medical Officer
Affiliation: Agensys, Inc.
Role: STUDY_DIRECTOR
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