Status:
COMPLETED
A Study of Volociximab in Combination With Gemcitabine in Metastatic Pancreatic Cancer
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that is required f...
Eligibility Criteria
Inclusion
- Male or female, 18 years of age or older.
- Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
- May have received prior immunotherapy (including monoclonal antibodies) or vaccine therapies.
- Measurable disease, according to RECIST criteria.
- Negative pregnancy test (women of childbearing potential only).
- Pretreatment laboratory levels that meet specific criteria.
Exclusion
- Prior treatment with Volociximab (M200) or inhibitors of α5β1 integrin (antibodies or small molecules) or gemcitabine and other chemotherapeutic regimens.
- Known hypersensitivity to murine proteins or chimeric antibodies or other components of the product.
- Use of any investigational drug within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer).
- Monoclonal antibody therapy within 4 weeks of the first dose of Volociximab.
- Central Nervous System (CNS) tumor or metastasis.
- History of bleeding disorders within the past year.
- Medical conditions that may be exacerbated by bleeding.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00401570
Start Date
March 1 2005
End Date
June 1 2008
Last Update
January 30 2013
Active Locations (6)
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1
Site Reference ID/Investigator# 70538
Pittsburgh, Pennsylvania, United States, 15213
2
Site Reference ID/Investigator# 70537
Nashville, Tennessee, United States, 37232-7415
3
Site Reference ID/Investigator# 70534
Glasgow, United Kingdom, G12 0YN
4
Site Reference ID/Investigator# 70533
Leeds, United Kingdom, LS16 6QB