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

• Status: Completed
• Trial end date: 2014-07-02
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

Criteria

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