A Study to Assess the Safety of Continued Administration of MDV3100 in Subjects With Prostate Cancer Who Showed Benefit From Prior Exposure to MDV3100
Condition: Castration-Resistant Prostate Cancer (CRPC)
MeSH terms: Prostatic Neoplasms
Intervention: Enzalutamide
Intervention description: Oral
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer; Castration-Resistant Prostate Cancer (CRPC); MDV3100; Androgen receptor signaling inhibitor

Summary:

      A study to assess the safety of continued administration of MDV3100 in subjects with Prostate
      Cancer who have already undergone treatment with MDV3100 and showed benefit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has completed a prior study with MDV3100, can be enrolled in this extension study
             without any interruption in study drug

          -  No new clinically significant abnormalities based upon physical examination, safety
             laboratory data, vital signs, ECG, and other clinical assessments noted from the last
             visit conducted during the subject's active MDV3100 study prior to initiation of this
             study

          -  Male subjects and their female spouses/partners who are of childbearing potential must
             be using highly effective contraception1 consisting of two forms of birth control (one
             of which must be a barrier method) starting at Screening and continue throughout the
             study period and for 3 months after final study drug administration. Male subjects
             must not donate sperm starting at Screening and throughout the study period and for at
             least 3 months after final study drug administration. 1Highly effective contraception
             is defined as:

               -  Established use of oral, injected or implanted hormonal methods of contraception.

               -  Placement of an intrauterine device (IUD) or intrauterine system (IUS).

               -  Barrier methods of contraception: Condom or occlusive cap (diaphragm or
                  cervical/vault caps) with spermicidal form/gel/film/ cream/suppository

          -  Subject agrees not to participate in another interventional study while on treatment

        Exclusion Criteria:

        Subject will be excluded from participation if any of the following apply:

          1. Subject has a history of seizure or any condition that may predispose to seizure
             including, but not limited to underlying brain injury, stroke, primary brain tumours,
             brain metastases, or alcoholism.

          2. Subject has a history of loss of consciousness or transient ischemic attack within 12
             months prior to Day 1 of the completed preceding study.

          3. Use of the following prohibited medication/therapies:

               -  Concomitant medication that likely could cause clinically relevant drug-to-drug
                  interactions with MDV3100.

               -  Other (than MDV3100) androgen-receptor (AR) antagonists (bicalutamide, flutamide,
                  nilutamide).

               -  Investigational therapy other than MDV3100 or investigational procedures of any
                  kind.