A Global, Multi-center, Open-label, Phase 2 Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects with Metastatic Pancreatic Cancer?Estudio global, multicéntrico, abierto, de fase II de AGS-1C4D4 administrado en combinación con gemcitabina en sujetos con cáncer de páncreas metastásico.
- Conditions
- Metastatic Pancreatic Cancer. To evaluate AGS-1C4D4 administered in combination with gemcitabine as measured by the survival rate at 6 months post-randomizationCancer de páncreas metástasico. Evaluar AGS-1C4D4 administrado en combinación con gemcitabina determinado mediante la tasa de supervivencia a los 6 meses después de la aleatorización
- Registration Number
- EUCTR2009-009194-99-ES
- Lead Sponsor
- Agensys Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 185
Inclusion
1.Man or woman 18 years of age or older
2.Pathologically confirmed metastatic adenocarcinoma of the pancreas (AJCC Stage IV). Subjects with islet cell neoplasms are excluded
3.Non-measurable or measurable disease based on the RECIST criteria
4.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
5.Life expectancy of > 3 months as documented by the investigator
6.Hematologic function, as follows:
a.Absolute neutrophil count (ANC)= 1.5 x 109/L
b.Platelet count = 100 x 109/L
c.Hemoglobin = 9 g/dL (transfusion independent)
7.Renal function, as follows:
a.Creatinine =2.0 mg/dL
8. Hepatic function, as follows:
a.Aspartate aminotransferase (AST) = 2.5 x ULN or = 5 x ULN if known liver metastases.
b.Alanine aminotransferase (ALT) = 2.5 x ULN
c.Bilirubin =2 x ULN
9. INR <1.3 (or 3 if on warfarin for therapeutic anti-coagulation)
10. Competent to comprehend, sign, and date an independent ethics committee/institutional review board (IEC/IRB) approved informed consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion
1.Prior systemic therapy for metastatic pancreatic cancer (prior systemic treatment for local disease is allowed)
2.Chemotherapy and/or radiation within 4 weeks of study enrollment
3.Prior monoclonal antibody therapy within 60 days of study enrollment
4.Brain or leptomeningeal disease
5.History of other primary malignancy, unless:
a.Curatively resected non-melanomatous skin cancer
b.Other malignancy curatively treated with no known active disease present and no treatment administered for the last 3 years
6.Active angina or Class III or IV Congestive Heart Failure (New York Heart Association CHF Functional Classification System)
7.Use of any investigational product within 4 weeks of study enrollment
8.Major surgery (that requires general anesthesia) within 4 weeks before study enrollment
9.Women who are pregnant (confirmed by positive pregnancy test) or lactating
10.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
11.Subject known to be human immunodeficiency, hepatitis B or hepatitis C virus positive
12.Active serious infection not controlled with antibiotics
13.Subject unwilling or unable to comply with study requirements
14.Known allergy to the ingredients of the study drug or to Staphylococcus protein A
15.Any medical or psychiatric disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method