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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-Label Phase 2 Study of AGS-1C4D4 in Pancreatic Cancer Subjects Previously Treated in Protocol 2008002

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Agensys, Inc.

Current Primary Outcome:

  • 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) ]


Original Primary Outcome:

  • 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) ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Astellas Pharma Inc

Dates:
Date Received: May 29, 2012
Date Started: August 7, 2012
Date Completion:
Last Updated: May 15, 2017
Last Verified: May 2017