Study of M200 (Volociximab) in Patients With Metastatic Renal Cell Carcinoma (RCC)

April 25, 2012 updated by: Abbott

Phase 2 Open-Label Study of Volociximab (M200) in Patients With Metastatic Renal Cell Carcinoma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients with a confirmed tumor response at any time during the study
Time Frame: Any time during the study
Any time during the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to disease progression
Time Frame: Up to 104 weeks
Up to 104 weeks
Duration of tumor response
Time Frame: Up to 104 weeks
Up to 104 weeks
Pharmacokinetics (PK) of M200
Time Frame: Day 0 through Study Termination
Day 0 through Study Termination
Immunogenicity
Time Frame: Day 0 through Study Termination
Day 0 through Study Termination

Collaborators and Investigators

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

Sponsor

Abbott

Investigators

  • Study Director: Mihail Obrocea, MD, Abbott

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 Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

January 4, 2005

First Submitted That Met QC Criteria

January 4, 2005

First Posted (Estimate)

January 5, 2005

Study Record Updates

Last Update Posted (Estimate)

April 27, 2012

Last Update Submitted That Met QC Criteria

April 25, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M200-1204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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