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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01608711
Other study ID # AGS-1C4D4-12-3
Secondary ID
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
Health authority
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

Study Design


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)
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