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Clinical Trial Summary

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


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01284920
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Completed
Phase Phase 1/Phase 2
Start date November 2, 2010
Completion date July 2, 2014

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