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OpenTrials
Completed

NCT Number: NCT00401570

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

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.

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Key information

Conditions

Pancreatic Cancer Carcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site Reference ID/Investigator# 70534, Glasgow, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Volociximab

Drug

Volociximab: 10 mg/kg or 15mg/kg every week or every other week (qowk) via IV infusion for up to 104 weeks.

Gemcitabine

Drug

Gemcitabine: Standard chemotherapy regime at 1 g/m2 once per week for 3 weeks via IV infusion, followed by one week with no treatment

Primary outcomes

  1. 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 outcomes

  1. Duration of progression-free survival

    Time frame: During the course of the trial (up to 104 weeks)

  2. Time to disease progression

    Time frame: During the course of the trial (up to 104 weeks)

  3. Duration of overall survival

    Time frame: During the course of the trial (up to 104 weeks)

  4. To evaluate the safety in of M200 in combination with gemcitabine

    Time frame: During the course of the trial (up to 104 weeks)

  5. To evaluate the pharmacokinetics of M200

    Time frame: During the course of the trial (up to 104 weeks)

  6. To evaluate the immunogenicity of M200

    Time frame: During the course of the trial (up to 104 weeks)

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Nov 20, 2006
Registry last updated
Jan 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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