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

AbbVie

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Gemcitabine; Drug: Volociximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00401570

M200-1205

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Volociximab (10 mg/kg every other week (qowk)) and Gemcitabine

Treatment:

Drug: Volociximab

Drug: Gemcitabine

Cohort 2

Experimental group

Description:

Volociximab (15 mg/kg weekly (qwk)) and Gemcitabine

Treatment:

Drug: Volociximab

Drug: Gemcitabine