Clinical trial NCT01902251: Relative Bioavailability Study of Enzalutamide in Prostate Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Pharmacokinetics of Enzalutamide
Keywords: Phase 1
Prostate cancer
Bioavailability
Food effect
Pharmacokinetics
Xtandi
Enzalutamide
MDV3100
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Medivation, Inc.
First posted: 2013-07-18
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 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.

Primary outcomes:
measure: Pharmacokinetic profile of Enzalutamide under fasted conditions measured by Cmax (Maximum concentration)
timeFrame: Day1 through Day 56 (12 samples)
measure: Pharmacokinetic profile of Enzalutamide under fasted conditions measured by AUC0-24h (Area under the concentration-time curve 0-24h)
timeFrame: Day1 through Day 56 (12 samples)
Secondary outcomes:
measure: Pharmacokinetic profile of Enzalutamide under fasted and fed conditions
timeFrame: Day 1, 8, 29, 55, 56 and 57 (38 samples)
measure: Pharmacokinetic profile of MDPC0001 alone, MDPC0002 alone and sum of Enzalutamide plus MDPC0002
timeFrame: Day 8, 29, 55, 56 and 57 (26 samples)
measure: Evaluation of the safety and tolerability of two oral formulations of Enzalutamide assessed through vital signs, adverse events, electrocardiogram and clinical laboratory assessments
timeFrame: Day 1 through Day 58
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado - Anschutz Medical Campus
state: Colorado
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics
state: Texas
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Clinical Study Manager
role: STUDY_DIRECTOR
References: