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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Agensys, Inc. )
ClinicalTrials.gov Identifier:
NCT01608711
First received: May 29, 2012
Last updated: May 15, 2017
Last verified: May 2017
  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
Pancreatic Cancer Carcinoma, Pancreatic Ductal Pancreatic Disease Biological: AGS-1C4D4 Biological: gemcitabine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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 ( Agensys, Inc. ):

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 31 months ]
    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) ]

Enrollment: 2
Actual Study Start Date: August 7, 2012
Study Completion Date: November 16, 2015
Primary Completion Date: November 16, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AGS-1C4D4 plus gemcitabine
Subjects will receive a maintenance dose of AGS-1C4D4 every 3 weeks (Q3W) in addition to the gemcitabine administration.
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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Responsible Party: 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: May 15, 2017

Keywords provided by Astellas Pharma Inc ( Agensys, Inc. ):
Gemcitabine
ASP6182
AGS-1C4D4
Pancreatic Cancer

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

ClinicalTrials.gov processed this record on July 27, 2017