Back to resultsA Study of Volociximab in Combination With Gemcitabine in Metastatic Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Volociximab
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Antibody, Pancreas, Carcinoma, Cancer, Pancreatic
Eligibility 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.
Sites / Locations
- Site Reference ID/Investigator# 70538
- Site Reference ID/Investigator# 70537
- Site Reference ID/Investigator# 70534
- Site Reference ID/Investigator# 70533
- Site Reference ID/Investigator# 70536
- Site Reference ID/Investigator# 70535
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Arm Description
Volociximab (10 mg/kg every other week (qowk)) and Gemcitabine
Volociximab (15 mg/kg weekly (qwk)) and Gemcitabine
Outcomes
Primary Outcome Measures
The proportion of patients, in each dose cohort, with a confirmed tumor response
Secondary Outcome Measures
Duration of progression-free survival
Time to disease progression
Duration of overall survival
To evaluate the safety in of M200 in combination with gemcitabine
To evaluate the pharmacokinetics of M200
To evaluate the immunogenicity of M200
Full Information
NCT ID
NCT00401570
First Posted
November 16, 2006
Last Updated
January 28, 2013
Sponsor
AbbVie (prior sponsor, Abbott)
1. Study Identification
Unique Protocol Identification Number
NCT00401570
Brief Title
A Study of Volociximab in Combination With Gemcitabine in Metastatic Pancreatic Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Antibody, Pancreas, Carcinoma, Cancer, Pancreatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Volociximab (10 mg/kg every other week (qowk)) and Gemcitabine
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Volociximab (15 mg/kg weekly (qwk)) and Gemcitabine
Intervention Type
Drug
Intervention Name(s)
Volociximab
Intervention Description
Volociximab: 10 mg/kg or 15mg/kg every week or every other week (qowk) via IV infusion for up to 104 weeks.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
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 Outcome Measure Information:
Title
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 Measure Information:
Title
Duration of progression-free survival
Time Frame
During the course of the trial (up to 104 weeks)
Title
Time to disease progression
Time Frame
During the course of the trial (up to 104 weeks)
Title
Duration of overall survival
Time Frame
During the course of the trial (up to 104 weeks)
Title
To evaluate the safety in of M200 in combination with gemcitabine
Time Frame
During the course of the trial (up to 104 weeks)
Title
To evaluate the pharmacokinetics of M200
Time Frame
During the course of the trial (up to 104 weeks)
Title
To evaluate the immunogenicity of M200
Time Frame
During the course of the trial (up to 104 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mihail Obrocea, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 70538
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Site Reference ID/Investigator# 70537
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-7415
Country
United States
Facility Name
Site Reference ID/Investigator# 70534
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 70533
City
Leeds
ZIP/Postal Code
LS16 6QB
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 70536
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Site Reference ID/Investigator# 70535
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of Volociximab in Combination With Gemcitabine in Metastatic Pancreatic Cancer
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