A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients

A Phase I/II, Open-Label, Uncontrolled, Dose-Escalation Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer

This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100 after oral administration to patients with castration-resistant prostate cancer.

This is a Phase1/2, open-label, uncontrolled study, involving Dose-Escalation Cohorts, where dose will be escalated to next dose with the safety, tolerability, and PK being evaluated in metastatic castration-resistant prostate cancer (mCRPC) patients and an Expansion Cohort, where the efficacy, safety, and PK of MDV3100 in post-chemo mCRPC patients will be evaluated. After evaluation of the safety and tolerability in Dose-Escalation Cohorts, additional patients are included in Expansion Cohort.

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate
• Ongoing androgen deprivation therapy with a GnRH analogue or a bilateral orchiectomy
• Progressive disease after prior androgen deprivation therapy (medical or surgical castration)
• For Expansion Cohort, the patient has no more than two prior chemotherapy regimens with at least one regimen containing docetaxel
• For Expansion Cohort, the patient must have measurable lesions by RECIST

Exclusion Criteria:

• Metastases in the brain
• History of another malignancy except for adenocarcinoma of the prostate within the previous 5 years
• Use of bicalutamide within 6 weeks prior to study
• Radiation therapy within 12 weeks prior to study
• Evidence of serious drug hypersensitivity