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

• Status: Terminated
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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 for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Antibodies; Antibodies, Monoclonal; Volociximab

Criteria

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.