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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Agensys, Inc. )
ClinicalTrials.gov Identifier:
NCT01608711
First received: May 29, 2012
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 19 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 19 months) ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: May 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608711

Locations
United States, Wisconsin
Medical College of Wisconsin
Madison, Wisconsin, United States, 53226
Canada
Sunnybrook Health Science Centre
Toronto, Canada, M4N 3M5
Sponsors and Collaborators
Agensys, Inc.
Investigators
Study Director: Medical Monitor Agensys, Inc.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Agensys, Inc. )
ClinicalTrials.gov Identifier: NCT01608711     History of Changes
Other Study ID Numbers: AGS-1C4D4-12-3
Study First Received: May 29, 2012
Last Updated: April 3, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Astellas Pharma Inc:
Gemcitabine
AGS-1C4D4
Pancreatic Cancer
ASP6182

Additional relevant MeSH terms:
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Carcinoma
Pancreatic Neoplasms
Carcinoma, Pancreatic Ductal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Carcinoma, Ductal
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
 Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on June 17, 2013