A Study of Volociximab in Combination With Gemcitabine in Metastatic Pancreatic Cancer

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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 for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Treatments: Antibodies, Monoclonal; Gemcitabine; Volociximab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.