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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00401570
First Posted: November 20, 2006
Last Update Posted: January 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
  Purpose
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.

Condition Intervention Phase
Pancreatic Cancer Drug: Volociximab Drug: Gemcitabine Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • Duration of progression-free survival [ Time Frame: 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) ]
  • Duration of overall survival [ Time Frame: 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) ]
  • To evaluate the pharmacokinetics of M200 [ Time Frame: 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) ]

Enrollment: 40
Study Start Date: March 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401570


Locations
United States, Pennsylvania
Site Reference ID/Investigator# 70538
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Site Reference ID/Investigator# 70537
Nashville, Tennessee, United States, 37232-7415
United Kingdom
Site Reference ID/Investigator# 70534
Glasgow, United Kingdom, G12 0YN
Site Reference ID/Investigator# 70533
Leeds, United Kingdom, LS16 6QB
Site Reference ID/Investigator# 70536
Manchester, United Kingdom, M20 4BX
Site Reference ID/Investigator# 70535
Northwood, United Kingdom, HA6 2RN
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Mihail Obrocea, MD AbbVie
  More Information

Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT00401570     History of Changes
Other Study ID Numbers: M200-1205
First Submitted: November 16, 2006
First Posted: November 20, 2006
Last Update Posted: January 30, 2013
Last Verified: January 2013

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Antibody
Pancreas
Carcinoma
Cancer
Pancreatic

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs