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Completed

NCT Number: NCT01608711

A 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.

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Key information

Conditions

Pancreatic Cancer Adenocarcinoma Carcinoma Carcinoma, Ductal Carcinoma, Pancreatic Ductal Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Pancreatic Disease Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site CA00203, Toronto, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AGS-1C4D4

Biological

Intravenous Infusion

Other names: ASP6182

Gemcitabine

Biological

Intravenous Infusion

Primary outcomes

  1. 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

  2. Incidence of anti-AGS-1C4D4 antibody formation

    Time frame: Every 8 weeks (up to 31 months)

Sponsors and collaborators

Lead sponsor

Agensys, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 31, 2012
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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