Status:
TERMINATED
Study of M200 (Volociximab) in Patients With Metastatic Renal Cell Carcinoma (RCC)
Lead Sponsor:
Abbott
Conditions:
Renal Cell Carcinoma
Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 fo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00100685
Start Date
January 1 2005
End Date
December 1 2007
Last Update
April 27 2012
Active Locations (3)
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1
Site Reference ID/Investigator# 70400
Los Angeles, California, United States, 90095
2
Site Reference ID/Investigator# 70401
New York, New York, United States, 10021
3
Site Reference ID/Investigator# 70399
Cleveland, Ohio, United States, 44195