Ph Ib/IIa Study of Cabazitaxel Plus Bavituximab in Castration-resistant Prostate Cancer

Inclusion Criteria:

* Written informed consent has been obtained.
* Adults 18 years of age or older with a life expectancy of at least 3 months.
* Histologically confirmed castration-resistant prostate cancer (CRPC). Patient must have demonstrated a rising PSA level above the androgen-deprivation therapy (ADT) nadir, on at least two determinations four weeks or more apart. ADT is defined as treatment with a Luteinizing-hormone-releasing hormone (LHRH) agonist or orchiectomy.
* Treatment with only one prior chemotherapy regimen, which must contain docetaxel as a single agent or in combination with other agents. Patients may be intolerant of, or resistant to, the cytotoxic drug combination.
* Patients on ADT must be willing to continue ADT for the duration of their participation in this protocol. ADT cannot be initiated, and ADT dose/agents may not be changed during the study.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Adequate hematologic function (absolute neutrophil count \[ANC\] ≥ 1,500 cells/μL; hemoglobin ≥ 8 g/dL, platelets ≥ 100,000/μL).
* Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min).
* Adequate hepatic function (bilirubin ≤ 1.0 x upper limit of normal \[ULN\], alanine aminotransferase \[ALT\] ≤ 1.5 x ULN, aspartate aminotransferase \[AST\] ≤ 1.5 x ULN).
* Prothrombin time (PT) / international normalized ratio (INR) ≤ 1.5 × ULN.
* Activated partial thromboplastin (aPTT) time ≤ 1.5 × ULN.
* Prostate-specific antigen (PSA) level of at least 2 ng/mL.
* New York Heart Association classification I or II.
* All patients of reproductive potential must agree to use an approved form of contraception (as determined by the investigator).

Exclusion Criteria:

* Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand disease or hemophilia).
* Any history of thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism); central venous catheter-related thrombosis \> 6 months before Screening is allowed.
* Ongoing therapy with oral or parenteral anticoagulants; patients on low-dose anticoagulants to maintain patency of central venous catheters are eligible.
* Grade 2 or higher peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities).
* Radiotherapy (teletherapy or brachytherapy) , chemotherapy or estrogen agonist within 28 days before Study Day 1.
* Systemic radiotherapy (Sm-153, Sr-89) within 56 days before study day 1.
* Symptomatic or clinically active brain metastases.
* Major surgery within 28 days of Study Day 1.
* Uncontrolled intercurrent disease (eg, diabetes, hypertension, thyroid disease).
* Any history of cerebrovascular accident, or transient ischemic attack at any time, or history of symptomatic coronary artery disease \< 6 months before screening.
* A history of any condition requiring anti-platelet therapy (eg, phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists), with the exception of general cardiovascular prophylaxis with aspirin (≤ 325 mg/day).
* Serious non-healing wound (including wound healing by secondary intention, ulcer, or bone fracture).
* Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis.
* Contraindication to intravenous (IV) contrast media.