Clinical Trial: A Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer

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

Official Title: A Global, Multi-center, Open-label, Phase 2 Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer

Brief Summary: A study to evaluate AGS-1C4D4 administered in combination with Gemcitabine chemotherapy in subjects with Metastatic Pancreatic Cancer.

Detailed Summary:

A disease assessment will be performed at study week 8 (± 3 days) by the investigator. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may continue to receive treatment based on their original treatment assignment until disease progression or intolerability. Disease assessments will be performed every 8 weeks during the extended period. A safety follow-up visit will occur 4 weeks after the last dose infusion of AGS-1C4D4 and/or gemcitabine.

Post-Treatment: Subjects terminating from protocol therapy for reasons unrelated to documented disease progression will be followed by telephone contact every 2 months until they begin a new anticancer therapy, their disease progresses, they die, become lost to follow-up or withdrawal consent for further follow-up, whichever of these events occurs first.

Overall survival: All subjects will be followed by telephone contact every 2 months until death, loss to follow-up, or withdrawal of consent, whichever of these events occurs first.


Sponsor: Astellas Pharma Inc

Current Primary Outcome: Survival rate at 6 months [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall Survival (OS) [ Time Frame: Throughout treatment period and post-treatment every 2 months until death, or subject discontinues the study ]
  • Progression free survival (PFS) [ Time Frame: Throughout treatment period or post-treatment every 2 months until disease progression or death, respectively, or subject discontinues the study ]
  • Change in level of serum tumor marker CA 19-9 [ Time Frame: Week 1, Week 4, Week 7 and every 3 weeks during the extended treatment period ]
  • Incidence of anti-AGS-1C4D4 antibody formation [ Time Frame: Week 1, Week 7 and every 8 weeks during the extended treatment period ]
  • Objective Response Rate (Partial Response or better per RECIST criteria version 1.1 [ Time Frame: Week 8, and every 8 weeks during the extended treatment period ]
  • Disease Control (Stable Disease or better per RECIST criteria) [ Time Frame: Week 8, and every 8 weeks during the extended treatment period ]


Original Secondary Outcome:

  • Overall Survival (OS) [ Time Frame: Throughout treatment period and post-treatment every 2 months until death, or subject discontinues the study ]
  • Progression free survival (PFS) [ Time Frame: Throughout treatment period or post-treatment every 2 months until disease progression or death, respectively, or subject discontinues the study ]
  • Best tumor response (stable disease, or better per RECIST criteria) [ Time Frame: Week 8, and every 8 weeks during the extended treatment period ]
  • Change in level of serum tumor marker CA 19-9 [ Time Frame: Week 1, Week 4, Week 7 and every 3 weeks during the extended treatment period ]
  • Incidence of anti-AGS-1C4D4 antibody formation [ Time Frame: Week 1, Week 7 and every 8 weeks during the extended treatment period ]


Information By: Astellas Pharma Inc

Dates:
Date Received: May 13, 2009
Date Started: April 2009
Date Completion:
Last Updated: August 31, 2015
Last Verified: August 2015