Study of AS1404 With Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer

Exclusion Criteria

• •Decreasing PSA levels after antiandrogen withdrawal
• •Previous chemotherapy treatment for prostate cancer
• •Patients who have received blood transfusions or growth factors to aid hematological recovery within two weeks of scheduled baseline visit
• •Concurrent severe and/or uncontrolled co-morbid medical condition within 2 weeks of screening
• •Previous exposure to AS1404 or other vascular targeting agents
• •Clinically significant cardiac arrhythmias and known QTc prolongation (interval \>450 msec)
• •Evidence of severe or uncontrolled systemic disease that, in the opinion of the Investigator, might interfere with the patient's participation in the study
• •A history of alcoholism; drug addiction; or any psychiatric condition, which, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures
• •A history of hypersensitivity to taxanes or other drugs formulated with polysorbate 80
• •Treatment with the following medications within two weeks of AS1404 administration or the expected need for such treatments during the study period:
• •* Medications known to modulate serotonin;
• •* Medications known to affect the QT interval;
• •* Current treatment with, or the expected need during the treatment period for ketoconazole, erythromycin, troleandomycin, and/or cyclosporine. The use of other agents known to induce, inhibit, or that are metabolized by cytochrome P450-3A4 should be undertaken with caution.
• •Concurrent or previous malignancy of a different tumor type within five years of starting the study, except for adequately treated non-melanoma skin cancer
• •Clinical or radiological evidence of central nervous system (CNS) metastases
• •Symptomatic peripheral neuropathy greater than or equal to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade II
• •Evidence of any other significant clinical disorder or laboratory finding that, in the opinion of the Investigator, compromises the patient safety during study participation
• •Participation in any prostate cancer investigational drug study in which the study drug has not subsequently obtained a product license
• •Any other concurrent treatment for prostate cancer (with the exception of palliative radiotherapy) other than that specified in the protocol, including the use of herbal remedies, (e.g. saw palmetto)