Status:
COMPLETED
Relative Bioavailability Study of Enzalutamide in Prostate Cancer Patients
Lead Sponsor:
Astellas Pharma Europe B.V.
Collaborating Sponsors:
Medivation, Inc.
Conditions:
Prostate Cancer
Pharmacokinetics of Enzalutamide
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
A multiple dose relative bioavailability study in patients with prostate cancer comparing a capsule and a tablet formulation of enzalutamide.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01902251
Start Date
November 1 2012
End Date
October 1 2013
Last Update
September 9 2014
Active Locations (4)
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1
University of Colorado - Anschutz Medical Campus
Denver, Colorado, United States, 80045
2
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
3
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
4
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229