NCT01902251

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 prostate-cancer

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_1 prostate-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 18, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

11 months

First QC Date

July 15, 2013

Last Update Submit

September 8, 2014

Conditions

Prostate CancerPharmacokinetics of Enzalutamide

Keywords

Phase 1Prostate cancerBioavailabilityFood effectPharmacokineticsXtandiEnzalutamideMDV3100

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Secondary Outcomes (3)

  • Pharmacokinetic profile of Enzalutamide under fasted and fed conditions

    Day 1, 8, 29, 55, 56 and 57 (38 samples)

  • Pharmacokinetic profile of MDPC0001 alone, MDPC0002 alone and sum of Enzalutamide plus MDPC0002

    Day 8, 29, 55, 56 and 57 (26 samples)

  • 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

Study Arms (2)

Enzalutamide tablet

EXPERIMENTAL

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

Drug: Enzalutamide tablet

Enzalutamide capsule

ACTIVE COMPARATOR

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

Drug: Enzalutamide capsule

Interventions

Enzalutamide tabletDRUG

Oral

Also known as: Xtandi, MDV3100
Enzalutamide tablet
Enzalutamide capsuleDRUG

Oral

Also known as: Xtandi, MDV3100
Enzalutamide capsule

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Colorado - Anschutz Medical Campus

Denver, Colorado, 80045, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

enzalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Clinical Study Manager

    Astellas Pharma Europe B.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2013

First Posted

July 18, 2013

Study Start

November 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

September 9, 2014

Record last verified: 2014-09

Locations

US(4)