Relative Bioavailability Study of Enzalutamide in Prostate Cancer Patients

This is an interventional basic science trial for Prostate Cancer focused on measuring Phase 1, Prostate cancer, Bioavailability, Food effect, Pharmacokinetics, Xtandi, Enzalutamide, MDV3100 Read More

Inclusion Criteria:

• Histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant setting). Subjects may be on ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., medical or surgical castration) at study entry.

• Progressive disease by Prostate-specific antigen (PSA) or imaging. Disease progression for study entry is defined as one or more of the following 3 criteria:

  • PSA progression defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each determination. The PSA value during the pre-investigational period should be ≥2 μg/L (2 ng/mL);
  • Soft tissue disease progression defined by the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) for soft tissue disease
  • Bone disease progression defined by two or more new lesions on bone scan

Exclusion Criteria:

• Treatment with chemotherapy within 4 weeks prior to enrollment (Day 1 visit) or plans to initiate treatment with chemotherapy during the study.
• History of seizure or any condition that may predispose to seizure. Also, history of loss of consciousness, or transient ischemic attack within 12 months prior to enrollment (Day 1 visit).
• Patients who previously received treatment with Enzalutamide.
• Concomitant use of drugs that are potent inducers and/or inhibitors of CYP3A4 and CYP2C8.
• Confirmed CYP2C8 poor metabolizer status based on genotyping analysis.