Relative Bioavailability Study of Enzalutamide in Prostate Cancer Patients

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

A multiple dose relative bioavailability study in patients with prostate cancer comparing a capsule and a tablet formulation of enzalutamide.

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

Details

• Lead Sponsor: Astellas Pharma Europe B.V.
• Collaborator: Medivation, Inc.

Criteria

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.