Relative Bioavailability Study of Enzalutamide in Prostate Cancer Patients

Completed · Phase 1

Conditions studied: Prostate Cancer, Pharmacokinetics of Enzalutamide

In brief

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

Key facts

Study ID

NCT01902251

Run by

Astellas Pharma Europe B.V.

People needed

27

Starts

2012-11-01

Expected to finish

2013-10-01

Last updated by the study team

2014-09-09

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Colorado - Anschutz Medical Campus — Denver, Colorado, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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