Study of Bafetinib (INNO-406) as Treatment for Patients With Hormone-Refractory Prostate Cancer

Inclusion Criteria: * Males age ≥18 years. * Histologically confirmed diagnosis of adenocarcinoma of the prostate. * Hormone-refractory prostate cancer having progressed despite androgen deprivation therapy that resulted in a castrated level of testosterone (\<50 ng/dL) or orchiectomy; with or without evidence of measurable or evaluable disease. * PSA increase defined as 2 consecutive rises; first increase in PSA occurred a minimum of 1 week from the reference value; increase in PSA should be at least 25% above the reference value and absolute PSA value should be \>5 ng/mL. * May have received no more than 1 prior chemotherapy regimen. Prior immunomodulatory therapy (sipuleucel-t (Provenge), interferon) is allowed. * Must be taking a single agent LHRH agonist or antagonist, unless previously underwent orchiectomy. * ECOG performance status 0-2. * Able to swallow pills. * Able to provide written, voluntary informed consent, comply with trial procedures, and have accessibility to the site. Exclusion Criteria: * Chemotherapy, antibody therapy, major surgery or irradiation within 4 weeks of study enrollment * Exposure to any investigational agent within 30 days of the Screening Visit. * No prior flutamide (Eulexin) and ketoconazole use within 4 weeks, bicalutamide (Casodex) within 6 weeks or nilutamide (Nilandron) within 6 weeks of study enrollment. * Use of Quadramet therapy during 2 months prior to study enrollment or Metastron ever. * Prior treatment with a tyrosine kinase inhibitor. * Subjects who have started bisphosphonate therapy within 4 weeks of study enrollment are excluded. Subjects treated with a stable dose of a bisphosphonate for \>4 weeks and the tumor has still progressed can be enrolled in the study. * Known CNS disease or CNS metastases. * History of other malignancies within the last five years except curatively treated basal cell carcinoma or superficial bladder cancer. * Laboratory values: Screening serum creatinine greater than or equal to 1.5 x ULN, alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, total bilirubin greater than 3 times the upper limit of normal, white blood cell (WBC) count \<3500/mm3, absolute neutrophil count \<1500/mm3, hematocrit level \<35% and platelets \<100,000/mm3. * History of abnormal bleeding or use of anticoagulant therapy. * Clinically evident congestive heart failure \>class II of the New York Heart Association (NYHA) guidelines. * Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V. * History of MI within 6 months or uncontrolled angina within 3 months. * Severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, chronic renal disease, chronic liver disease. * Known HIV infection. * Uncontrolled active, infection. * Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results. * Any condition that in the opinion of the Investigator is unstable and could jeopardize the subject's participation in the study.