A Study of Volociximab in Combination With Gemcitabine in Metastatic Pancreatic Cancer - Full Text View

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by AbbVie:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:	NCT00401570 History of Changes
Other Study ID Numbers:	M200-1205
Study First Received:	November 16, 2006
Last Updated:	January 28, 2013
Health Authority:	United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AbbVie:

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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 22, 2013