A Study Of Volociximab In Combination With Gemcitabine In Metastatic Pancreatic Cancer

Study Overview

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.

N/A

Pancreatic Cancer

DRUG: Volociximab
DRUG: Gemcitabine

M200-1205

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-11-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-01-28
First Submitted that Met QC Criteria 2006-11-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-01-30
First Posted (ESTIMATED) 2006-11-20	Results First Posted N/A	Last Verified 2013-01

Study Plan

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

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

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

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

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

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

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

Investigators

STUDY_DIRECTOR: Mihail Obrocea, MD, AbbVie

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record