A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/16/2019
Start Date:December 22, 2016
End Date:July 2021
Contact:Astellas Pharma Global Development
Email:astellas.registration@astellas.com
Phone:800-888-7704

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A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

The purpose of this study is to collect long term safety data in subjects who are continuing
to derive clinical benefit from treatment with Enzalutamide from the subjects participation
in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study)
which has completed, at a minimum, the primary analysis or the study specified evaluation
period.

Subjects should continue on the treatment regimen that the subject was receiving in the prior
study. Dose changes of any of the prior therapies subjects were receiving on the previous
protocol are allowed after medical monitor approval. The day 1 visit for this study should
coincide with the last treatment visit for the study the subject will be enrolling from (≤ 7
days post last visit of parent study). The subjects will be followed according to the local
institution's standard of care and will be required to return to the institution every 12
weeks (± 7 days) to review adverse events (AEs), collect concomitant medications, confirm
that no discontinuation criteria are met, return all dispensed study drug and to receive more
study drug if applicable. All AEs (new and ongoing from the study the subject is enrolling
from) and Serious Adverse Events (SAEs) (including death), will be collected from the time
the subject signs the consent form until the end of study visit.

Inclusion Criteria:

- Subject must currently be receiving enzalutamide for prostate cancer in a study
sponsored by Astellas or Medivation and, based on the investigator's assessment,
benefit from continued treatment. Subjects participating in investigator-initiated
trials are not eligible.

- Subject is able to continue on the treatment regimen that the subject was receiving in
the prior study. If in the investigator's assessment, a change is needed to the
subject's regimen (e.g., dose change in Androgen deprivation therapy (ADT) or dropping
of a combination therapy) approval from a medical monitor is required prior to
enrollment.

- Subject is able to swallow enzalutamide capsules and comply with study requirements.

- Subject and female partner who is of childbearing potential must continue to use 2
forms of birth control, of which 1 must be highly effective and 1 must be a barrier
method throughout the study and for 3 months after final enzalutamide administration.

- Subject agrees to avoid sperm donation during the study and for at least 3 months
after final enzalutamide administration.

- Subject agrees not to participate in another interventional study while on treatment.

Exclusion Criteria:

- Subject met any of the discontinuation criteria or whose cancer progressed on the
current enzalutamide clinical study in which subject is enrolling from.

- Subject requires treatment with or plans to use either of the following:

- New systemic therapy for subjects cancer (palliative radiation therapy is
allowed). The treatment with agents administered during previous studies which
was stopped and then restarted during this study does not represent new
treatment.

- Investigational therapy other than enzalutamide.

- Subject is currently participating in an investigator-initiated interventional trial
and receiving enzalutamide.

- Subject has any concurrent disease, infection, or comorbid condition that interferes
with the ability of the subject to participate in the study, which places the subject
at undue risk or complicates the interpretation of data.
We found this trial at
36
sites
Jacksonville, Florida 32256
2138
mi
from 91732
Jacksonville, FL
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Anchorage, Alaska 99503
2344
mi
from 91732
Anchorage, AK
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Aurora, Colorado 80045
825
mi
from 91732
Aurora, CO
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Chapel Hill, North Carolina 27514
1991
mi
from 91732
Chapel Hill, NC
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Charleston, South Carolina 29424
2184
mi
from 91732
Charleston, SC
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Chicago, Illinois 60612
1728
mi
from 91732
Chicago, IL
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Cincinnati, Ohio 45242
1882
mi
from 91732
Cincinnati, OH
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Concord, North Carolina 28025
2114
mi
from 91732
Concord, NC
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Cordorba,
?
mi
from 91732
Cordorba,
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Dallas, Texas 75246
1223
mi
from 91732
Dallas, TX
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Daytona Beach, Florida 32114
2189
mi
from 91732
Daytona Beach, FL
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Denver, Colorado 80239
818
mi
from 91732
Denver, CO
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Garden City, New York 11530
2452
mi
from 91732
Garden City, NY
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Greensboro, North Carolina 27403
2151
mi
from 91732
Greensboro, NC
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Hackensack, New Jersey 07601
2430
mi
from 91732
Hackensack, NJ
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Houston, Texas 77030
1357
mi
from 91732
Houston, TX
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Jeffersonville, Indiana 47130
1813
mi
from 91732
Jeffersonville, IN
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Lancaster, Pennsylvania 17604
2314
mi
from 91732
Lancaster, PA
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Los Angeles, California 90033
13
mi
from 91732
Los Angeles, CA
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Madison, Wisconsin 53792
1655
mi
from 91732
Madison, WI
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Myrtle Beach, South Carolina 29572
2233
mi
from 91732
Myrtle Beach, SC
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Nashville, Tennessee 37232
1762
mi
from 91732
Nashville, TN
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Norfolk, Virginia 23502
2341
mi
from 91732
Norfolk, VA
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Omaha, Nebraska 68114
1301
mi
from 91732
Omaha, NE
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Pittsburgh, Pennsylvania 15213
2119
mi
from 91732
Pittsburgh, PA
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Saint Louis, Missouri 63110
1573
mi
from 91732
Saint Louis, MO
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San Bernardino, California 92404
41
mi
from 91732
San Bernardino, CA
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San Diego, California 92123
124
mi
from 91732
San Diego, CA
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Seattle, Washington 98101
961
mi
from 91732
Seattle, WA
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Springfield, Oregon 97477
739
mi
from 91732
Springfield, OR
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Stanford, California 94305
328
mi
from 91732
Stanford, CA
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Towson, Maryland 21204
2301
mi
from 91732
Towson, MD
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Tucson, Arizona 85719
427
mi
from 91732
Tucson, AZ
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Virginia Beach, Virginia 23462
2354
mi
from 91732
Virginia Beach, VA
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Washington, District of Columbia 20007
2279
mi
from 91732
Washington,
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Winston-Salem, North Carolina 27157
2125
mi
from 91732
Winston-Salem, NC
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