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Relative Bioavailability Study of Enzalutamide in Prostate Cancer Patients

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ClinicalTrials.gov Identifier: NCT01902251
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : September 9, 2014
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Pharmacokinetics of Enzalutamide Drug: Enzalutamide tablet Drug: Enzalutamide capsule Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : November 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Enzalutamide tablet
Multiple once daily oral doses of enzalutamide formulated as a tablet for approximately 8 weeks
Drug: Enzalutamide tablet
Oral
Other Names:
  • Xtandi
  • MDV3100

Active Comparator: Enzalutamide capsule
Multiple once daily oral doses of enzalutamide formulated as liquid-filled soft gelatin capsule for approximately 8 weeks
Drug: Enzalutamide capsule
Oral
Other Names:
  • Xtandi
  • MDV3100




Primary Outcome Measures :
  1. Pharmacokinetic profile of Enzalutamide under fasted conditions measured by Cmax (Maximum concentration) [ Time Frame: Day1 through Day 56 (12 samples) ]
    Day 56 (fasted) Cmax under steady state conditions of enzalutamide

  2. Pharmacokinetic profile of Enzalutamide under fasted conditions measured by AUC0-24h (Area under the concentration-time curve 0-24h) [ Time Frame: Day1 through Day 56 (12 samples) ]
    Day 56 (fasted) AUC0-24h under steady state conditions of enzalutamide


Secondary Outcome Measures :
  1. Pharmacokinetic profile of Enzalutamide under fasted and fed conditions [ Time Frame: Day 1, 8, 29, 55, 56 and 57 (38 samples) ]
    Measured by: Cmax, tmax (Time to attain Cmax), AUC0-24h, Ctrough (Trough concentration), PTR (Peak-trough ratio), CLss/F (Apparent clearance at steady state)

  2. Pharmacokinetic profile of MDPC0001 alone, MDPC0002 alone and sum of Enzalutamide plus MDPC0002 [ Time Frame: Day 8, 29, 55, 56 and 57 (26 samples) ]
    Measured by: Ctrough, Cmax, tmax, AUC0-24h, Ctrough (24h after dosing), PTR

  3. Evaluation of the safety and tolerability of two oral formulations of Enzalutamide assessed through vital signs, adverse events, electrocardiogram and clinical laboratory assessments [ Time Frame: Day 1 through Day 58 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902251


Locations
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United States, Colorado
University of Colorado - Anschutz Medical Campus
Denver, Colorado, United States, 80045
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Medivation, Inc.
Investigators
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Study Director: Clinical Study Manager Astellas Pharma Europe B.V.

Additional Information:
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Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT01902251     History of Changes
Other Study ID Numbers: 9785-CL-0003
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: September 2014

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
Phase 1
Prostate cancer
Bioavailability
Food effect
Pharmacokinetics
Xtandi
Enzalutamide
MDV3100

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases