Study of M200 (Volociximab) in Patients With Metastatic Renal Cell Carcinoma (RCC)
Stopped early · Phase 2
Conditions studied: Renal Cell Carcinoma, Metastases
In brief
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.
Key facts
- Study ID
- NCT00100685
- Run by
- Abbott
- People needed
- 48
- Starts
- 2005-01-01
- Expected to finish
- 2007-12-01
- Last updated by the study team
- 2012-04-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Site Reference ID/Investigator# 70400 — Los Angeles, California, United States
- Site Reference ID/Investigator# 70401 — New York, New York, United States
- Site Reference ID/Investigator# 70399 — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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