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

Phase 2

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: Volociximab; Drug: Gemcitabine

• Registration Number: NCT00401570
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2006-11-16
• Study First Submitted QC: 2006-11-16
• Study First Posted: 2006-11-20
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Disposition First Submitted: 2012-04-25
• Disposition First Submitted QC: 2012-04-25
• Disposition First Posted: 2012-04-27
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2	Gemcitabine	Volociximab (15 mg/kg weekly (qwk)) and Gemcitabine
Cohort 1	Gemcitabine	Volociximab (10 mg/kg every other week (qowk)) and Gemcitabine
Cohort 2	Volociximab	Volociximab (15 mg/kg weekly (qwk)) and Gemcitabine
Cohort 1	Volociximab	Volociximab (10 mg/kg every other week (qowk)) and Gemcitabine

Primary Outcome Measures

Name	Time	Method
The proportion of patients, in each dose cohort, with a confirmed tumor response	Any time during the course of the trial (up to 104 weeks)

Secondary Outcome Measures

Name	Time	Method
Duration of progression-free survival	During the course of the trial (up to 104 weeks)
Time to disease progression	During the course of the trial (up to 104 weeks)
Duration of overall survival	During the course of the trial (up to 104 weeks)
To evaluate the safety in of M200 in combination with gemcitabine	During the course of the trial (up to 104 weeks)
To evaluate the pharmacokinetics of M200	During the course of the trial (up to 104 weeks)
To evaluate the immunogenicity of M200	During the course of the trial (up to 104 weeks)

Trial Locations

Locations (6)

Site Reference ID/Investigator# 70536; 🇬🇧 Manchester, United Kingdom

Site Reference ID/Investigator# 70534; 🇬🇧 Glasgow, United Kingdom

Site Reference ID/Investigator# 70538; 🇺🇸 Pittsburgh, Pennsylvania, United States

Site Reference ID/Investigator# 70533; 🇬🇧 Leeds, United Kingdom

Site Reference ID/Investigator# 70535; 🇬🇧 Northwood, United Kingdom

Site Reference ID/Investigator# 70537; 🇺🇸 Nashville, Tennessee, United States