Study of M200 (Volociximab) in Patients With Metastatic Renal Cell Carcinoma (RCC) - 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) and is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.

Condition	Intervention	Phase
Renal Cell Carcinoma Metastases	Drug: Volociximab (anti-α5β1 integrin monoclonal antibody)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 2 Open-Label Study of Volociximab (M200) in Patients With Metastatic Renal Cell Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

The proportion of patients with a confirmed tumor response at any time during the study [ Time Frame: Any time during the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to disease progression [ Time Frame: Up to 104 weeks ] [ Designated as safety issue: No ]
Duration of tumor response [ Time Frame: Up to 104 weeks ] [ Designated as safety issue: No ]
Pharmacokinetics (PK) of M200 [ Time Frame: Day 0 through Study Termination ] [ Designated as safety issue: No ]
Immunogenicity [ Time Frame: Day 0 through Study Termination ] [ Designated as safety issue: No ]

Enrollment:	48
Study Start Date:	January 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 Volociximab administered intravenously at a dose of 10 mg/kg qowk	Drug: Volociximab (anti-α5β1 integrin monoclonal antibody) Volociximab intravenously (Cohort 1: 10 mg/kg every other week or Cohort 2: 15 mg/kg once a week) for up to 104 weeks or until disease progression, whichever occurs first.
Experimental: Arm 2 Volociximab administered intravenously at a dose of 15 mg/kg qwk	Drug: Volociximab (anti-α5β1 integrin monoclonal antibody) Volociximab intravenously (Cohort 1: 10 mg/kg every other week or Cohort 2: 15 mg/kg once a week) for up to 104 weeks or until disease progression, whichever occurs first.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Males and females of at least 18 years of age with metastatic RCC of predominantly clear cell histology who have received 0 to 2 prior treatment regimens for metastatic disease.
Measurable disease according to Response Criteria for Solid Tumors.
Negative pregnancy test (women of childbearing potential only).
Pretreatment laboratory levels that meet specific criteria.
Signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations
Patients must have failed at least one approved or investigational tyrosine kinase inhibitor (TKI).

Exclusion Criteria

Any of the following histologies of RCC: papillary, chromophobe, collecting duct, or unclassified.
Known sensitivity 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).
Systemic chemotherapy, immunotherapy, radiation therapy, or monoclonal antibody therapy within 4 weeks of M200 administration.
Documented central nervous system (CNS) tumor or CNS metastasis.
History of thromboembolic events and 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: NCT00100685

Locations

United States, California
Site Reference ID/Investigator# 70400
Los Angeles, California, United States, 90095
United States, New York
Site Reference ID/Investigator# 70401
New York, New York, United States, 10021
United States, Ohio
Site Reference ID/Investigator# 70399
Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Mihail Obrocea, MD

Abbott

More Information

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT00100685 History of Changes
Obsolete Identifiers:	NCT00103077
Other Study ID Numbers:	M200-1204
Study First Received:	January 4, 2005
Last Updated:	April 25, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Kidney
renal
cancer
carcinoma

cell
metastatic
metastatic renal cell carcinoma
RCC

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Renal Cell
Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms

Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplastic Processes
Pathologic Processes
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013