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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Pancreatic Ductal, Pancreatic Cancer, Pancreatic Disease

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of adverse events

Outcome Description:

Grade 3 and 4 adverse events, treatment-related adverse events, serious adverse events and adverse events requiring discontinuation of AGS-1C4D4

Outcome Time Frame:

19 months

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Agensys, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

AGS-1C4D4-12-3

NCT ID:

NCT01608711

Start Date:

May 2012

Completion Date:

December 2013

Related Keywords:

  • Carcinoma, Pancreatic Ductal
  • Pancreatic Cancer
  • Pancreatic Disease
  • Gemcitabine
  • AGS-1C4D4
  • Pancreatic Cancer
  • ASP6182
  • Carcinoma
  • Pancreatic Diseases
  • Pancreatic Neoplasms
  • Carcinoma, Pancreatic Ductal

Name

Location

Medical College of WisconsinMilwaukee, Wisconsin  53226