Relative Bioavailability Study of Enzalutamide in Prostate Cancer Patients

Prostate Cancer Clinical Trial

Official title:

A Phase I, Open-label, Randomized, Parallel, Relative Bioavailability Study Comparing a Capsule and a Tablet Formulation of Enzalutamide Following Multiple Once Daily Doses of 160 mg Enzalutamide in Male Subjects With Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01902251
• Other study ID #: 9785-CL-0003
• Status: Completed
• Phase: Phase 1
• First received: July 15, 2013
• Last updated: September 8, 2014
• Start date: November 2012
• Est. completion date: October 2013

Study information

• Verified date: September 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pharmacokinetics of Enzalutamide
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Enzalutamide tablet
Oral
• Enzalutamide capsule
Oral

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University of Colorado - Anschutz Medical Campus	Denver	Colorado
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	South Texas Accelerated Research Therapeutics	San Antonio	Texas

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic profile of Enzalutamide under fasted conditions measured by Cmax (Maximum concentration)	Day 56 (fasted) Cmax under steady state conditions of enzalutamide	Day1 through Day 56 (12 samples)	No
Primary	Pharmacokinetic profile of Enzalutamide under fasted conditions measured by AUC0-24h (Area under the concentration-time curve 0-24h)	Day 56 (fasted) AUC0-24h under steady state conditions of enzalutamide	Day1 through Day 56 (12 samples)	No
Secondary	Pharmacokinetic profile of Enzalutamide under fasted and fed conditions	Measured by: Cmax, tmax (Time to attain Cmax), AUC0-24h, Ctrough (Trough concentration), PTR (Peak-trough ratio), CLss/F (Apparent clearance at steady state)	Day 1, 8, 29, 55, 56 and 57 (38 samples)	No
Secondary	Pharmacokinetic profile of MDPC0001 alone, MDPC0002 alone and sum of Enzalutamide plus MDPC0002	Measured by: Ctrough, Cmax, tmax, AUC0-24h, Ctrough (24h after dosing), PTR	Day 8, 29, 55, 56 and 57 (26 samples)	No
Secondary	Evaluation of the safety and tolerability of two oral formulations of Enzalutamide assessed through vital signs, adverse events, electrocardiogram and clinical laboratory assessments		Day 1 through Day 58	No

External Links

•   Link to Results on JAPIC - enter 140588 in the JapicCTI-RNo. field