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Clinical Trials/EUCTR2009-009194-99-ES
EUCTR2009-009194-99-ESActive, not recruitingNot Applicable

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.

Agensys Inc0 sites185 target enrollmentStarted: February 23, 2010Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
185
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •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 Criteria

  • •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

Investigators

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