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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01608711
• Other study ID #: AGS-1C4D4-12-3
• Status: Completed
• Phase: Phase 2
• First received: May 29, 2012
• Last updated: May 15, 2017
• Start date: August 7, 2012
• Est. completion date: November 16, 2015

Study information

• Verified date: May 2017
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: November 16, 2015
• Est. primary completion date: November 16, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Pancreatic Ductal
• Pancreatic Cancer
• Pancreatic Disease
• Pancreatic Diseases
• Pancreatic Neoplasms

Intervention

Biological:
• AGS-1C4D4
Intravenous Infusion
• gemcitabine
Intravenous Infusion

Locations

Country	Name	City	State
Canada	Site CA00203	Toronto
United States	Site US116	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Agensys, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events	Grade 3 and 4 adverse events, treatment-related adverse events, serious adverse events and adverse events requiring discontinuation of AGS-1C4D4	31 months
Primary	Incidence of anti-AGS-1C4D4 antibody formation		Every 8 weeks (up to 31 months)