 - Treatment with chemotherapy, hormonal therapy except GnRH agonists or antagonists for prostate cancer, immunotherapy, biologic therapy, or radiation therapy except palliative radiation to bony metastases as cancer therapy within 4 weeks prior to initiation of study treatment exceptions are kinase inhibitors that are approved by the local regulatory authorities, which may be used within 2 weeks prior to initiation of study treatment, provided that any drug-related toxicity has completely resolved and after approval by the Medical Monitor has been granted 