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

Pancreatic Cancer Clinical Trial

Official title:

Phase 2 Open-Label Study of Volociximab (M200) in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer Not Previously Treated With Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401570
• Other study ID #: M200-1205
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2006
• Last updated: January 28, 2013
• Start date: March 2005
• Est. completion date: June 2008

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 a5ß1 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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Volociximab
Volociximab: 10 mg/kg or 15mg/kg every week or every other week (qowk) via IV infusion for up to 104 weeks.
• Gemcitabine
Gemcitabine: Standard chemotherapy regime at 1 g/m2 once per week for 3 weeks via IV infusion, followed by one week with no treatment

Locations

Country	Name	City	State
United Kingdom	Site Reference ID/Investigator# 70534	Glasgow
United Kingdom	Site Reference ID/Investigator# 70533	Leeds
United Kingdom	Site Reference ID/Investigator# 70536	Manchester
United Kingdom	Site Reference ID/Investigator# 70535	Northwood
United States	Site Reference ID/Investigator# 70537	Nashville	Tennessee
United States	Site Reference ID/Investigator# 70538	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Duration of progression-free survival		During the course of the trial (up to 104 weeks)	No
Secondary	Time to disease progression		During the course of the trial (up to 104 weeks)	No
Secondary	Duration of overall survival		During the course of the trial (up to 104 weeks)	No
Secondary	To evaluate the safety in of M200 in combination with gemcitabine		During the course of the trial (up to 104 weeks)	Yes
Secondary	To evaluate the pharmacokinetics of M200		During the course of the trial (up to 104 weeks)	No
Secondary	To evaluate the immunogenicity of M200		During the course of the trial (up to 104 weeks)	No