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

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ClinicalTrials.gov Identifier: NCT01608711
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Agensys, Inc. )

May 29, 2012
May 31, 2012
May 16, 2017
August 7, 2012
November 16, 2015   (Final data collection date for primary outcome measure)
  • 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) ]
  • Incidence of adverse events [ Time Frame: 19 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 19 months) ]
Complete list of historical versions of study NCT01608711 on ClinicalTrials.gov Archive Site
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A Study of AGS-1C4D4 in Pancreatic Cancer Subjects Previously Treated in Protocol 2008002
An Open-Label Phase 2 Study of AGS-1C4D4 in Pancreatic Cancer Subjects Previously Treated in Protocol 2008002
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pancreatic Cancer
  • Carcinoma, Pancreatic Ductal
  • Pancreatic Disease
  • Biological: AGS-1C4D4
    Intravenous Infusion
    Other Name: ASP6182
  • Biological: gemcitabine
    Intravenous Infusion
Experimental: AGS-1C4D4 plus gemcitabine
Subjects will receive a maintenance dose of AGS-1C4D4 every 3 weeks (Q3W) in addition to the gemcitabine administration.
Interventions:
  • Biological: AGS-1C4D4
  • Biological: gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
Same as current
November 16, 2015
November 16, 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT01608711
AGS-1C4D4-12-3
No
Not Provided
Not Provided
Astellas Pharma Inc ( Agensys, Inc. )
Agensys, Inc.
Not Provided
Study Director: Medical Monitor Agensys, Inc.
Astellas Pharma Inc
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP