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

January 28, 2013 updated by: AbbVie (prior sponsor, Abbott)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • Site Reference ID/Investigator# 70534
      • Leeds, United Kingdom, LS16 6QB
        • Site Reference ID/Investigator# 70533
      • Manchester, United Kingdom, M20 4BX
        • Site Reference ID/Investigator# 70536
      • Northwood, United Kingdom, HA6 2RN
        • Site Reference ID/Investigator# 70535
  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Site Reference ID/Investigator# 70538
    • Tennessee
      • Nashville, Tennessee, United States, 37232-7415
        • Site Reference ID/Investigator# 70537

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cohort 1
Volociximab (10 mg/kg every other week (qowk)) and Gemcitabine
Drug: Volociximab
Volociximab: 10 mg/kg or 15mg/kg every week or every other week (qowk) via IV infusion for up to 104 weeks.
Drug: 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
EXPERIMENTAL: Cohort 2
Volociximab (15 mg/kg weekly (qwk)) and Gemcitabine
Drug: Volociximab
Volociximab: 10 mg/kg or 15mg/kg every week or every other week (qowk) via IV infusion for up to 104 weeks.
Drug: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

November 16, 2006

First Submitted That Met QC Criteria

November 16, 2006

First Posted (ESTIMATE)

November 20, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

January 30, 2013

Last Update Submitted That Met QC Criteria

January 28, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M200-1205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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