Study of Bavituximab in Patients With Advanced Solid Tumor Malignancies

Inclusion Criteria:

* At least 18 years of age with life expectancy of 3 months
* Evaluable, histologically or cytologically confirmed, refractory advanced solid tumor malignancy
* ECOG score of less than or equal to 1
* Adequate hematologic function (absolute neutrophil count \[ANC\] greater than or equal to 1,500 cells/uL; hemoglobin greater than or equal to 9 g/dL; platelets greater than or equal to 100,000/uL and less than or equal to 500,000/uL)
* Adequate renal function (serum creatinine less than or equal to 1.5 mg/dL or calculated creatinine clearance greater than 60 mL/min)
* Adequate hepatic function (bilirubin less than or equal to 1.5 x ULN; ALT less than or equal to 3 x ULN; AST less than or equal to 3 x ULN)
* Normal coagulation profile (prothrombin time/international normalized ratio \[PT/INR\] and activated partial thromboplastin time \[aPTT\] within institutional normal limits)
* D-dimer less than or equal to 2 times upper limit of institutional normal
* New York Heart Association classification I or II for patients with significant cardiopulmonary disease
* Female patients must have a negative serum pregnancy test at prestudy and all patients of reproductive potential must be willing to use an approved form of barrier method contraception

Exclusion Criteria:

* Prior exposure to any chimeric antibody
* Any evidence of clinically significant bleeding
* Known history of bleeding diathesis or coagulopathy
* Any history of thromboembolic events including central venous catheter-related thrombosis within the past 12 months
* Any evidence or history of hypercoagulable state (eg, shortened aPTT)
* Concurrent therapy with oral or parenteral anticoagulants
* Concurrent hormone therapy (ie, estrogen contraceptives, hormone replacement, anti-estrogen)
* Chemotherapy, immunotherapy or radiotherapy within 4 weeks of day 0 (6 weeks for nitrosoureas and mitomycin C) or have not recovered from treatment-related side effects due to agents administered more than 4 weeks earlier (stable, non-hematological residual toxicities of Grade 1 or less and Grade 2 dry skin or alopecia are allowed)
* Investigational therapy within 4 weeks of day 0
* Evidence of central nervous system (CNS) metastatic disease at prestudy (no active brain metastases on magnetic resonance imaging \[MRI\] at prestudy)
* Major surgery within 4 weeks of day 0
* Pregnant or nursing women
* Uncontrolled intercurrent disease (eg, diabetes, hypertension, thyroid disease)
* Any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack
* A history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin
* A history of any condition requiring treatment (past or current) with coumarin-type agents within the past 12 months
* Cardiac arrhythmia requiring medical therapy
* Serious non-healing wound
* Requirement for chronic daily treatment with non-steroidal anti-inflammatory drugs (NSAIDs), anti-platelet drugs (eg, phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists) or steroids
* Known chronic infection with HIV or hepatitis