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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00401570
First received: November 16, 2006
Last updated: January 28, 2013
Last verified: January 2013

November 16, 2006
January 28, 2013
March 2005
June 2008   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
The proportion of patients, in each dose cohort, with a confirmed tumor response at any time during the study
Complete list of historical versions of study NCT00401570 on ClinicalTrials.gov Archive Site
  • Duration of progression-free survival [ Time Frame: During the course of the trial (up to 104 weeks) ] [ Designated as safety issue: No ]
  • Time to disease progression [ Time Frame: During the course of the trial (up to 104 weeks) ] [ Designated as safety issue: No ]
  • Duration of overall survival [ Time Frame: During the course of the trial (up to 104 weeks) ] [ Designated as safety issue: No ]
  • To evaluate the safety in of M200 in combination with gemcitabine [ Time Frame: During the course of the trial (up to 104 weeks) ] [ Designated as safety issue: Yes ]
  • To evaluate the pharmacokinetics of M200 [ Time Frame: During the course of the trial (up to 104 weeks) ] [ Designated as safety issue: No ]
  • To evaluate the immunogenicity of M200 [ Time Frame: During the course of the trial (up to 104 weeks) ] [ Designated as safety issue: No ]
  • Duration of progression-free survival
  • Time to disease progression
  • Duration of overall survival
  • Assessment of adverse events and serious adverse events, abnormal physical examination findings, and abnormal laboratory values
  • PK
  • Immunogenicity
Not Provided
Not Provided
 
A Study of Volociximab in Combination With Gemcitabine in Metastatic Pancreatic Cancer
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
  • 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 1
    Volociximab (10 mg/kg every other week (qowk)) and Gemcitabine
    Interventions:
    • Drug: Volociximab
    • Drug: Gemcitabine
  • Experimental: Cohort 2
    Volociximab (15 mg/kg weekly (qwk)) and Gemcitabine
    Interventions:
    • Drug: Volociximab
    • Drug: Gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2008
June 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT00401570
M200-1205
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Mihail Obrocea, MD AbbVie
AbbVie
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP