- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00100685
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
-
-
California
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Los Angeles, California, United States, 90095
- Site Reference ID/Investigator# 70400
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-
New York
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New York, New York, United States, 10021
- Site Reference ID/Investigator# 70401
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Ohio
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Cleveland, Ohio, United States, 44195
- Site Reference ID/Investigator# 70399
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-
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
|
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.
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Experimental: Arm 2
Volociximab administered intravenously at a dose of 15 mg/kg qwk
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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
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
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Antibodies
- Antibodies, Monoclonal
- Volociximab
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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