Status:
COMPLETED
A Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Agensys, Inc.
Conditions:
Carcinoma, Pancreatic Ductal
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 evid...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT00902291
Start Date
April 1 2009
End Date
April 1 2012
Last Update
September 14 2015
Active Locations (36)
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1
University of California San Diego Medical Center
La Jolla, California, United States, 92093
2
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, United States, 33435
3
University of Miami
Miami, Florida, United States, 33136
4
Medical Oncology LLC
Baton Rouge, Louisiana, United States, 70809