NCT01284920

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Prostate Cancer
• Prostate Neoplasms
• Castration Resistant Prostate Cancer (CRPC)

Interventions

Type	Name	Description
DRUG	MDV3100	oral

Timeline

• Start date: 2010-11-02
• Primary completion: 2012-07-12
• Completion: 2014-07-02
• First posted: 2011-01-27
• Last updated: 2024-11-21

Locations

7 sites across 1 country: Japan