Trial record 2 of 4 for:    Aicardi-Goutieres Syndrome Disorder

A Study of AGS-1C4D4 in Pancreatic Cancer Subjects Previously Treated in Protocol 2008002

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Agensys, Inc. ) Identifier:
First received: May 29, 2012
Last updated: December 10, 2015
Last verified: December 2015
The purpose of this study is to continue the safety and immunogenicity of AGS-1C4D4 administered in combination with gemcitabine in subjects previously treated in protocol 2008002.

Condition Intervention Phase
Carcinoma, Pancreatic Ductal
Pancreatic Cancer
Pancreatic Disease
Biological: AGS-1C4D4
Biological: gemcitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Phase 2 Study of AGS-1C4D4 in Pancreatic Cancer Subjects Previously Treated in Protocol 2008002

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 31 months ] [ Designated as safety issue: Yes ]
    Grade 3 and 4 adverse events, treatment-related adverse events, serious adverse events and adverse events requiring discontinuation of AGS-1C4D4

  • Incidence of anti-AGS-1C4D4 antibody formation [ Time Frame: Every 8 weeks (up to 31 months) ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: May 2012
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AGS-1C4D4 plus gemcitabine Biological: AGS-1C4D4
Intravenous Infusion
Other Name: ASP6182
Biological: gemcitabine
Intravenous Infusion

Detailed Description:

Subjects will receive a maintenance dose of AGS-1C4D4 every 3 weeks (Q3W) in addition to the gemcitabine administration. If subjects have grade 4 adverse events considered to be related to AGS-1C4D4 at anytime during the study, AGS-1C4D4 treatment will be discontinued for that subject.

Subjects will continue to have their tumor status assessed by computerized tomography (CT) and magnetic resonance (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) guidelines every eight weeks (Q8W). Subjects without evidence of disease progression will continue to receive AGS-1C4D4 and gemcitabine until intolerability, disease progression or consent withdrawal.

Subjects who discontinue AGS-1C4D4 for any reason will undergo an end of study visit 4 weeks after their last AGS-1C4D4 infusion.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject has stable disease or better per Response Evaluation Criteria in Solid Tumors (RECIST) criteria v.1.1. in Protocol 2008002

Exclusion Criteria:

  • More than 6 weeks (2 doses) has lapsed from the time of the last infusion in AGS-1C4D4 Protocol 2008002
  • Use of the following prohibited medications / therapies:

    • Monoclonal antibody therapy, other than AGS-1C4D4
    • Chemotherapy, other than gemcitabine
    • Investigational therapy other than AGS-1C4D4
    • Erlotinib (Tarceva)
  • Any clinical condition which would not allow safe conduct of this study
  Contacts and Locations
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Please refer to this study by its identifier: NCT01608711

United States, Wisconsin
Site US116
Madison, Wisconsin, United States, 53226
Site CA00203
Toronto, Canada, M4N 3M5
Sponsors and Collaborators
Agensys, Inc.
Study Director: Medical Monitor Agensys, Inc.
  More Information

Responsible Party: Astellas Pharma Inc ( Agensys, Inc. ) Identifier: NCT01608711     History of Changes
Other Study ID Numbers: AGS-1C4D4-12-3 
Study First Received: May 29, 2012
Last Updated: December 10, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Astellas Pharma Inc:
Pancreatic Cancer

Additional relevant MeSH terms:
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Carcinoma, Pancreatic Ductal
Pancreatic Neoplasms
Carcinoma, Ductal
Digestive System Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Glandular and Epithelial
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 24, 2016