Clinical trial NCT01335204 (phase 1/phase 2, status: terminated)
Conditions: prostate cancer, prostatic neoplasms
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, B38.81, N42.31, Z87.430, N40.0, N40.1
Drugs: cabazitaxel plus bavituximab
SMILES: [H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C4=CC=CC=C4)C(C)=C([C@@H](OC)C(=O)[C@]1(C)[C@H](C[C@H]1OC[C@@]21OC(C)=O)OC)C3(C)C
Reason stopped: 
    lack of funding
  
Eligibility criteria:

        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.