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

This is an interventional treatment trial for Prostate Cancer focused on measuring Castration-resistant prostate cancer, Prostate Cancer, JEVTANA, Cabazitaxel, Bavituximab Read More

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.