Phase 2 Open-Label Study of Volociximab (M200) in Patients With Metastatic Renal Cell Carcinoma
- 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
- 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
- Any of the following histologies of RCC: papillary, chromophobe, collecting duct, or
- Known sensitivity to murine proteins or chimeric antibodies or other components of
- 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.