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

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.