Trial Information

Summary: A Phase 1 Study of Bavituximab in Patients with Solid Tumors

The main purpose of this research study is to test the safety of the study drug Bavituximab at different dose levels. The effects Bavituximab has on patients and their cancer, good and/or bad, will be examined. This study will also try to characterize the pharmacokinetic profile of Bavituximab administered intravenously. Pharmacokinetics is a way to study how the body processes a drug by looking at how the body absorbs (takes drug into the blood), distributes (delivers drug through the body), metabolizes (breaks down or processes the drug), and eliminates (removes) drugs.

Patients are being asked to participate in this study because their cancer is advanced and either there is no standard cure or the standard cure is no longer working for their cancer. This study uses the investigational drug Bavituximab which has not been approved for use by the U.S. Food and Drug Administration (FDA). Its use in this study is experimental. Bavituximab is designed to attach to tumor blood vessels without binding to blood vessels in normal organs. The tumor blood vessels are then destroyed, blood flow to the tumor stops, and the tumor's growth is then limited due to lack of oxygen and nutrients.

Patient Inclusion Criteria:

• evaluable, histologically or cytologically confirmed refractory advanced solid tumor
• adequate bone marrow, liver and renal function
• d-dimer up to 2 times the institutional upper normal limits

Not all eligibility criteria are listed. Additional criteria must be met in order to be eligible.

Patient Exclusion Criteria:

• prior exposure to a chimeric antibody (Avastin-okay, Erbitux- not okay)
• any gross hematuria
• hemoptysis or GI bleeding
• any history of DVT or PE
• any evidence or history of hypercoagulable state
• concurrent therapy with oral or parenteral anticoagulants
• symptomatic or active brain metastases
• uncontrolled intercurrent disease (thyroid, diabetes, hypertension)

If you would like to learn more about participating in this study, please send an e-mail message using the form below.