Relative Bioavailability Study of Enzalutamide in Prostate Cancer Patients

NCT ID: NCT01902251

Last Updated: 2014-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-10-31

Brief Summary

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

Conditions

Prostate Cancer; Pharmacokinetics of Enzalutamide

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Enzalutamide tablet

Multiple once daily oral doses of enzalutamide formulated as a tablet for approximately 8 weeks

Group Type: EXPERIMENTAL

Enzalutamide tablet

Intervention Type: DRUG

Oral

Enzalutamide capsule

Multiple once daily oral doses of enzalutamide formulated as liquid-filled soft gelatin capsule for approximately 8 weeks

Group Type: ACTIVE_COMPARATOR

Enzalutamide capsule

Intervention Type: DRUG

Oral

Interventions

Enzalutamide tablet

Oral

Intervention Type: DRUG

Enzalutamide capsule

Oral

Intervention Type: DRUG

Other Intervention Names

Xtandi; MDV3100; Xtandi; MDV3100

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Medivation, Inc.

INDUSTRY

Sponsor Role: collaborator

Astellas Pharma Europe B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Study Manager

Role: STUDY_DIRECTOR

Astellas Pharma Europe B.V.

Locations

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

Countries

United States

Other Identifiers

9785-CL-0003

Identifier Type: -

Identifier Source: org_study_id